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Cutting-edge Advancements
Clinical Diagnosis
OphthalmologyTimes.com
follow us online:
Special Reprt
NEWER ICLS MAY
reduce CATARACT
formation rate
Surgery
May 2016 Vol. 41, No. 8
Drug therapy
Perfecting
capsulotomy
Novel disposable tool could provide several
advantages compared with femtosecond laser
VIDEO
This video shows the
final design of the
disposable intraocular
nanopulse technology
(Zepto) inserting
through a 2.2-mm
incision and performing
a 5-mm capsulotomy in
a cadaver eye.
Go to bit.ly/1SFHhoh
Oviedo, Spain :: cataract formation has been associated with the first
phakic IOLs introduced into the marketplace. However, newer models seem to
be on the way to solving that problem,
said Jose F. Alfonso, MD, PhD. Because
implantable collamer lenses meet a
need in the refractive surgery arena
for patients with high refractive levels,
they have been gaining in popularity.
(Video courtesy of Mynosys)
( See story on page 22 : Cataract )
Clinical Diagnosis
Tell us at ASCRS Booth 1523.
Growing up
with glaucoma
into adulthood
By Cheryl Guttman Krader;
mies created with either the femtosecond laser or
Reviewed by David F. Chang, MD
a manual technique,” Dr. Chang said.
miami :: what happens to children
The technology consists of a control console and
treated for glaucoma as they grow older?
a disposable handpiece containing the capsulotomy
Los Altos, CA ::
The short answer is that life goes on.
Precision pulse capsulotomy tip. The tip is comprised of a 6-mm silicone suction
Just like other kids, they want to be
(PPC) performed using novel disposable intraocular cup and the cutting element—a 5-mm nitinol capsuactive, get an education, have a career,
lotomy ring. Using just a small amount of vacuum,
nanopulse technology (Zepto, Mynosys) may be a
date, get married, and have children.
step forward toward the ideal capsulotomy, accord- the suction cup apposes the anterior capsule to the
But even if their glaucoma has been
cutting element and also shields surrounding tising to David F. Chang, MD.
effectively cured, the impact lingers.
“PPC is an exciting new method that like a fem- sues from the energy delivery.
“They have anatomical things that have
A retractable push rod extends to stretch the captosecond laser could quickly and reliably create a
followed them, and they have other
perfectly circular capsulotomy with a precise di- sulotomy tip into an elongated shape so that it can
baggage that has followed them,” said
ameter,” said Dr. Chang, private practice, Los Altos, enter through a sub-2.2-mm clear corneal incision.
Alana L. Grajewski, MD. Though the
©
2016 Abbott Medical Optics Inc.CA,
| www.AbbottMedicalOptics.com
| PP2016MLT0048
“The nitinol used for the capsulotomy ring is a
and clinical professor of ophthalmology, Unianatomical issues have been well studshape memory alloy, which means that it can be
versity of California, San Francisco. “However, PPC
ied, literature on the psychological-socollapsed to allow insertion through a small corhas advantages of being lower cost and able to be
cial burden of childhood glaucoma on
used without disruption of the conventional sur- neal incision and then will rebound back from the
children and families is limited, and
deformation to its native circular shape and diamgical sequence.
these quality-of-life issues should be
eter,” Dr. Chang explained.
“As another bonus, PPC also seems to create a
examined more formally.
( See story on page 14 : Pediatric glaucoma )
capsulotomy with a stronger edge than capsuloto-
( Continues on page 9 : Capsulotomy )
CUTTING-EDGE ADVANCEMENTS
CLINICAL DIAGNOSIS
OphthalmologyTimes.com
FOLLOW US ONLINE:
Special Reprt
NEWER ICLS MAY
REDUCE CATARACT
FORMATION RATE
SURGERY
May 2016 VOL. 41, NO. 8
DRUG THERAPY
Perfecting
CAPSULOTOMY
Novel disposable tool could provide several
advantages compared with femtosecond laser
VIDEO
This video shows the
final design of the
disposable intraocular
nanopulse technology
(Zepto) inserting
through a 2.2-mm
incision and performing
a 5-mm capsulotomy in
a cadaver eye.
Go to bit.ly/1SFHhoh
OVIEDO, SPAIN :: CATARACT formation has been associated with the first
phakic IOLs introduced into the marketplace. However, newer models seem to
be on the way to solving that problem,
said Jose F. Alfonso, MD, PhD. Because
implantable collamer lenses meet a
need in the refractive surgery arena
for patients with high refractive levels,
they have been gaining in popularity.
(Video courtesy of Mynosys)
( See story on page 22 : Cataract )
Clinical Diagnosis
GROWING UP
WITH GLAUCOMA
INTO ADULTHOOD
MIAMI :: WHAT HAPPENS to children
treated for glaucoma as they grow older?
The short answer is that life goes on.
Just like other kids, they want to be
active, get an education, have a career,
date, get married, and have children.
But even if their glaucoma has been
followed them, and they have other
baggage that has followed them,” said
Alana L. Grajewski, MD. Though the
anatomical issues have been well studied, literature on the psychological-social burden of childhood glaucoma on
children and families is limited, and
these quality-of-life issues should be
examined more formally.
( See story on page 14 : Pediatric glaucoma )
By Cheryl Guttman Krader;
Reviewed by David F. Chang, MD
LOS ALTOS, CA ::
PRECISION PULSE CAPSULOTOMY
(PPC) performed using novel disposable intraocular
nanopulse technology (Zepto, Mynosys) may be a
step forward toward the ideal capsulotomy, according to David F. Chang, MD.
“PPC is an exciting new method that like a femtosecond laser could quickly and reliably create a
perfectly circular capsulotomy with a precise diameter,” said Dr. Chang, private practice, Los Altos,
CA, and clinical professor of ophthalmology, University of California, San Francisco. “However, PPC
has advantages of being lower cost and able to be
used without disruption of the conventional surgical sequence.
“As another bonus, PPC also seems to create a
capsulotomy with a stronger edge than capsuloto-
mies created with either the femtosecond laser or
a manual technique,” Dr. Chang said.
The technology consists of a control console and
a disposable handpiece containing the capsulotomy
tip. The tip is comprised of a 6-mm silicone suction
cup and the cutting element—a 5-mm nitinol capsulotomy ring. Using just a small amount of vacuum,
the suction cup apposes the anterior capsule to the
cutting element and also shields surrounding tissues from the energy delivery.
A retractable push rod extends to stretch the capsulotomy tip into an elongated shape so that it can
enter through a sub-2.2-mm clear corneal incision.
“The nitinol used for the capsulotomy ring is a
shape memory alloy, which means that it can be
collapsed to allow insertion through a small corneal incision and then will rebound back from the
deformation to its native circular shape and diameter,” Dr. Chang explained.
( Continues on page 9 : Capsulotomy )
Because getting it right the first time
is better than getting there first.
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1093 Rev.D
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MAY 2016
contents
22
46
28
39
38
Surgery
Clinical Diagnosis
Practice Management
8 SINGLE TREATMENT FOR
BILATERAL GLAUCOMA?
16 IN-OFFICE THERAPY MAY
OFFER MGD RELIEF
39 FOR WHOSE CONVENIENCE:
PRACTICE OR PATIENT?
Laser therapy reduces IOP, lowers
patient reliance on medication
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MAY 2016 :: Ophthalmology Times
editorial
MAY 2016 ◾ VOL. 41, NO. 8
CONTENT
My drug of choice: Dopamine
What attracts the attention of neurons in ophthalmologists
By Peter J. McDonnell, MD
director of the Wilmer Eye Institute,
Johns Hopkins University School of
Medicine, Baltimore, and chief medical
editor of Ophthalmology Times.
He can be reached at 727 Maumenee Building
600 N. Wolfe St. Baltimore, MD 21287-9278
Phone: 443/287-1511 Fax: 443/287-1514
E-mail: pmcdonn1@jhmi.edu
FOR SOME TIME, I find myself looking at
my smartphone with a frequency that is frankly
disconcerting. In committee meetings, lectures,
sporting venues, social events, and other settings, my eyes and fingers find themselves gravitating to that little rectangular device.
The screen comes to life when my fingerprint
is recognized and some bit of data, a text or
email message, a news headline or other snippet of information is delivered to me.
TAKING IT ALL IN
It turns out that our senses present our brains
with too much input for us to attend to it all.
The process of picking what deserves our attention is called “attentional orienting,” and this is
“like tuning a radio to a specific frequency.”
Susan Courtney, PhD, a professor of psychological and brain sciences at my university,
monitored the brains of subjects using a PET
scanner. When her subjects saw an object that
had rewarded them in the past, they focused
their attention in on it, and “a part of their
brains involved in attention became flushed
with dopamine . . . Our brains pull us back to
things that rewarded us in the past.”
Scientists call this “reward conditioning”
and the PET scan images show dark pixels in
the brain slices that apparently represent dopamine being squirted into certain regions.
Those neurons are getting their little fixes from
the neurotransmitter that makes them happy.
Kind of like a bunch of ophthalmologists at
“happy hour” on a Friday evening after a long week of helping people see and documenting in their electronic health
records. Hence, my tendency
to keep checking my phone is
explained.
There are three other items
that cause the neurons of ophthalmologists to focus attention and garner their rewards
of dopamine molecules, just like the dolphins
at water parks receiving their fish snacks after
their jump through rings of fire. Those include:
‘This phone habit of mine
is not like a chemical
dependency— it is a
chemical dependency.’
Sometimes, there is good news. Sometimes, great news. Occasionally, the news is
disappointing.
And sometimes there really isn’t any news
worth seeing. Then I put the device down, only
to find myself looking back at it within a few
minutes.
Some people are critical of this habit. They
say that looking at a phone all day means you
are not fully engaged with your surroundings
and not living in the moment. But I have found
it very, very difficult to stop.
Now I know why. This phone habit of mine
is not like a chemical dependency—it is a
chemical dependency.
Or so says recent research published in Current Biology.1 My attention was garnered in an
article about this work entitled “Why You Can’t
Stop Checking Your Phone.”2
1. Femtophaco lasers
2. Syringes filled with anti-VEGF agents
3. Each and every issue of Ophthalmology Times Q
References
1. Anderson BA et al. The role of dopamine in value-based
attentional orienting. Current Biology. 2016;26:550-555.
2. Why You Can’t Stop Checking Your Phone. Johns Hopkins
Magazine. Vol. 68, Spring 2016.
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8
surgery
Modality approaches bilateral
glaucoma in single treatment
Laser therapy gives patients access to strategy that reduces IOP, lowers reliance on drugs
By Ahad Mahootchi, MD, Special to Ophthalmology Times
get tissue, as well as
less destructive to tar*
get and adjacent tissue. MP allows for a
39.3
treatment effect with> 33% IOP reduction at 18 months,
out the inflammation
n = 38 patients
and destructive effect
> 61% medication reduction (2.1 to 1.3)
associated with con> 73% success rate with 1.3 sessions
31.1
tinuous wave laser.
28.0
I prefer to perform
27.4
27.1
26.2
26.6
25.8
MicroPulse TSCPC for
about 3 minutes total,
or about 90 seconds in
each hemisphere, in
Baseline
1 day
1 wk
1 mo
3 mos
6 mos
12 mos
18 mos
patients with darker
colored irises. The
*Tan A, Chockalingam M, Aquino M, Lim Z, See J, Chew P. Micropulse
treatment duration
transscleral diode laser cyclophotocoagulation in the treatment of refractory
m ight increase to
glaucoma. Clin Experiment Ophthalmol. 2010;38:266–272.
100 to 110 seconds
per hemisphere in a
(FIGURE 1) Evidence that the laser therapy is effective even in the most
difficult cases is demonstrated in a recent prospective interventional
blue eye.
case series by Tan et al. (Figure courtesy of Ahad Mahootchi, MD)
Because the MicroPulse TSCPC has a favorable safety profile
A NOV EL T R E AT MEN T
The probe powered by the laser may look simi- it is widely applicable. I have used it for a wide I contacted these researchers to see what they
lar to traditional transcleral cyclophotocoagu- range of cases, ranging from mild to end-stage, thought the durability of MicroPulse TSCPC may
and have yet to find a patient type in which be. Dr. Tan and colleagues reported to me that
lation (TSCPC).
However, there is nothing similar in regard it is not a viable option. Even in uveitis-prone many of the patients they followed in the study
to patient selection or postop experience to the patients I have not stirred up iritis.
were still doing well 5 and even 6 years after
Evidence that MicroPulse TSCPC is effec- a single treatment (personal communication).
patient or physician. It may look like the laser
cyclodestructive procedures of yester-year when tive even in the most difficult cases is demonI have performed MicroPulse TSCPC now in
performing this 3-minute procedure. That is strated in a recent prospective interventional 75 cases with a full range of glaucoma, from
case series by Tan et al.2
where the similarity ends.
mild to severe, using varying treatment endPatients recover vision in minIn a series of 40 eyes of 38 points. In some cases, the goal was to achieve
utes and are free of pain and
consecutive patients with re- lower pressure, while in others, patients exLaser therapy that
inflammation. The ciliary body
fractory glaucoma, mean IOP pressed a desire to reduce their reliance on
approaches bilateral
laser treatment does not ablate
was reduced from 39.3 ± 12.6 costly glaucoma drops. Regardless, the preglaucoma in a single
the ciliary body. The mechanism
mm Hg at baseline to 31.1 ± defined treatment endpoint has been achieved
treatment provides
is believed to enhance uveo13.4 mm Hg at 1 day, 28.0 ± in 73 of these cases.
greater efficacy for
scleral outflow in addition to
Ultimately, MicroPulse TSCPC may supplant
12.0 mm Hg at 1 week, 27.4 ±
the practice and
affecting outflow.1
12.7 mm Hg at 1 month, 27.1 ± many current intermediary approaches to glaumore convenience for
13.6 mm Hg at 3 months, 25.8 ± coma. It is easier to perform than a valve proAlthough seemingly counterpatients.
14.5 mm Hg at 6 months, 26.6 cedure or a trabeculectomy, and has a much
intuitive, MicroPulse is not sim± 14.7 mm Hg at 12 months, more favorable safety profile.
ply a reduction in laser power
It can easily be a first-line therapy for peoand 26.2 ± 14.3 mm Hg at 18
or a way to adjust the interval;
rather, MicroPulse is a different way of ap- months (p < 0.001 at all time points (Figure 1). ple who cannot afford or do not want to use
Before investing in a P3 probe for my clinic,
plying laser—both more specific to the tarContinues on page 9 : Single treatment
T
TAKE-HOME
NUHS Prospective Clinical Study
IOP (mmHg)
hough medical therapy is the typical first line-treatment strategy in
glaucoma, there is much interest
in developing therapy approaches
that effectively lower IOP while reducing the need for drop therapy.
Incisional surgical options typically remain a consideration for end-stage
disease, while the largest need in glaucoma
management is an approach for the majority
of patients with mild-to-moderate glaucoma.
In particular, laser therapy offers a viable
strategy for these patients, although not all
platforms for delivery are equal.
The MicroPulse P3 (MP3) probe powered
by the Cyclo G6 laser (Iridex) is a powerfulyet-gentle treatment for a range of patients,
equally applicable to wide assortment of glaucoma types. This modality represents a new
way to treat glaucoma that results in pressure
reductions while lessening patients’ reliance
on medical therapy.
surgery
CAPSULOTOMY
( Continued from page 1 )
To make the capsulotomy, very low energy
electrical impulses are delivered to the cutting
ring. This causes a rapid and momentary increase of temperature, leading to vaporization
of water molecules that are trapped between
the cutting ring and the capsule. The result
is instantaneous mechanical cleavage of the
capsule membrane around the entire circumference of the ring in about 4 ms.
“There is no heating of the tissue with this
technique, and it is not cautery, which would create a capsulotomy with a weaker edge,” he said.
Once the capsulotomy is made, the suction
is released, and the device is withdrawn from
the eye along with the excised capsule disc.
PPC performance has been evaluated in several studies. Results from a series of investigations conducted by Dr. Chang with Nick
Mamalis, MD, and Liliana Werner, MD, PhD,
in human cadaver eyes and in vivo in rabbit
eyes highlighted the safety and efficacy of the
novel tool for creating round, complete capsulotomies [Ophthalmology. 2016;123:255-264].
Serial slit lamp examination in the animal
eyes showed no differences comparing eyes that
underwent PPC and fellow eyes in which capsulotomy was done using manual continuous
SINGLE TREATMENT
drops, yet it is also a successful adjunctive option when drop therapy does not achieve the
target pressure. It is more widely applicable
than laser trabeculoplasty; it can also be used
at the time of cataract surgery, although unlike some of the MIGS category, it can be reimbursed as a stand-alone procedure.
The availability of MicroPulse TSCPC has
allowed us to design a treatment algorithm for
bilateral treatment of glaucoma, which would
not be possible with other treatments, because
of visual morbidity.
When I have a patient with bilateral glaucoma, I will bring him or her to the operating
room and use a very low dose combination
of Fentanyl, Versed, and Propofol to induce
a mild anesthetic state without ophthalmic
blocking for the 6 minutes it takes to apply the
treatment. We have found that we can avoid
using a block at all. As a result, patients are
The technology consists of a control console and a disposable handpiece containing the capsulotomy tip.
The tip is comprised of a 6-mm silicone suction cup and the cutting element—a 5-mm nitinol capsulotomy
ring. (Image courtesy of Mynosy)
curvilinear capsulorhexis (CCC) with respect
to corneal edema, anterior chamber inflammation, capsular fibrosis, or capsule opacification.
“We also used a thermocouple to measure
temperature change at the iris and corneal endothelium during the PPC and found negligible
increases in both duration and magnitude,” Dr.
Chang said.
The capsulotomies created with the nanopulse technology were found to be perfectly
circular and free of tags. Intraoperative MiyakeApple videos obtained during a study using
paired human cadaver eyes showed minimal
zonular movement during the procedure that
was no different than that occurring during
manual CCC. Imaging of human cadaver capsulotomies with scanning electron microscopy
showed the capsule edges had the same smooth
appearance of those created by manual CCC.
In collaboration with Vance M. Thompson,
MD, John P. Berdahl, MD, and Joel M. Solano,
MD, a comparative study in paired human cadaver eyes evaluated rim strength of capsulotomies created using the PPC technology, a femtosecond laser, or manual CCC [Ophthalmology.
2016;123:265-274]. The PPC capsulotomies were
consistently the most resistant to tearing when
capsulotomy edge retractors attached to force
transducers were used to stretch the edge.
“The finding that the PPC capsulotomy edge
was significantly stronger was intriguing,” Dr.
Chang said. ■
able to leave the recovery area in 15 minutes
or less. They return to normal activities immediately after that. The postoperative recovery
area is never congested when using the lowdose anesthesia.
nient for patients. This is not just a new way
to perform the same treatments that are performed with standard continuous wave laser,
it gives patients access to a safe and effective
treatment strategy that reduces IOP and lessens dependence on medical therapy. ■
CONCLUSION
About one-half of patients who respond to treatment do so within 2 weeks. After the first
couple of cases, I realized that inflammation
was significantly reduced compared with other
procedures and laser treatments, and so it was
unnecessary to see patients back on the first
post-treatment day.
As a result, the need for follow-up examinations is based on how badly the visual field
is at baseline. If the field is not terrible, (as
most mild-to-moderate cases are) there is a
bit more latitude in bringing the patient back
for follow-up.
This treatment modality has proven to be
an effective addition to practice. Addressing
bilateral glaucoma in a single treatment—one
that does not depend on patients’ compliance—
is more efficient for practice and more conve-
DAVID F. CHANG, MD
E: dceye@earthlink.net
This article was adapted from Dr. Chang’s presentation at the 2015 meeting of the
European Society of Cataract and Refractive Surgeons. Dr. Chang is a consultant for
Mynosys.
References
1. Radcliffe N, Vold S, Kammer JA, et al. MicroPulse
trans-scleral cyclophotocoagulation (mTSCPC) for
the treatment of glaucoma using the MicroPulse P3
Device. Presented at the American Glaucoma Society
annual meeting, 2015.
2. Tan AM, Chockalingam M, Aquino MC, Lim ZI, See
JL, Chew PT. Micropulse transscleral diode laser
cyclophotocoagulation in the treatment of refractory
glaucoma. Clin Experiment Ophthalmol. 2010;38:266272.
AHAD MAHOOTCHI, MD
P: 813/779-3338 E: am@seebetterflorida.com
Ahad Mahootchi, MD, is medical director of The Eye Clinic of Florida,
Zephyrhills, FL. He is a consultant and speaker for Iridex.
9
Making Allergic Conjunctivitis
Treatment a Priority
Marguerite B. McDonald, MD, FACS, and John D. Sheppard, MD, MMSc
We make treating allergic
conjunctivitis a priority by making
sure our patients get BEPREVE®
(bepotastine besilate ophthalmic
solution) 1.5%, for severe itch
due to allergic conjunctivitis, and
ALREX® (loteprednol etabonate
ophthalmic suspension 0.2%), for
multiple signs and symptoms of
seasonal allergic conjunctivitis.
Ocular allergy affects up to 20%
of the US population—more than
60 million Americans.1,2 Yet in spite
of its prevalence, ocular allergy is
underrecognized.1,2 Why?
Perhaps because perennial or
seasonal ocular allergies are not
blinding. Despite the fact that perennial
or seasonal ocular allergies are not
blinding, we as ophthalmologists need
to recognize allergic conjunctivitis as
an important condition to diagnose and
treat appropriately.
Conjunctivitis can result in symptoms
that may contribute to discontinuation of
contact lens wear and interference with
surgical outcomes.3-5
BY NO MEANS BENIGN
When allergic conjunctivitis inflames
the ocular surface, fluid can accumulate
in the subconjunctival space. Repeated
cycles of inflammation can cause chalasis,
subconjunctival hemorrhages, and
inhibition of the normal distribution and
collection of tears.
When patients with allergic
conjunctivitis rub their eyes, they
INDICATION
IMPORTANT SAFETY INFORMATION
BEPREVE® (bepotastine besilate ophthalmic solution)
1.5% is a histamine H1 receptor antagonist indicated
for the treatment of itching associated with signs
and symptoms of allergic conjunctivitis.
• ALREX® (loteprednol etabonate ophthalmic
suspension 0.2%) is contraindicated in most viral
diseases of the cornea and conjunctiva including
epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of the
ocular structures. ALREX® is also contraindicated in
individuals with known or suspected hypersensitivity to any of the ingredients of this preparation
and to other corticosteroids.
• Prolonged use of ALREX® is associated with several warnings and precautions, including glaucoma
with optic nerve damage, defects in visual acuity,
cataract formation, secondary ocular infections, exacerbation or prolongation of viral ocular infections
(including herpes simplex), delay in wound healing
and increase in bleb formation.
• If this product is used for 10 days or longer, intraocular pressure should be monitored. The initial
prescription and renewal of the medication order
beyond 14 days should be made by a physician
only after examination of the patient with the aid
of magnification.
• Ocular adverse reactions occurring in 5-15% of
patients treated with loteprednol etabonate ophthalmic suspension (0.2%-0.5%) in clinical studies
included abnormal vision/blurring, burning on
instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and
photophobia.
• BEPREVE® is contraindicated in patients with a
history of hypersensitivity reactions to bepotastine
or any of the other ingredients.
• BEPREVE® is for topical ophthalmic use only. To
minimize risk of contamination, do not touch the
dropper tip to the eyelids or to any surface. Keep
the bottle closed when not in use.
• BEPREVE® should not be used to treat contact
lens-related irritation. Remove contact lens prior to
instillation of BEPREVE®. Lenses may be reinserted
10 minutes after BEPREVE® administration.
• The most common adverse reaction occurring in
approximately 25% of patients was a mild taste
following instillation. Other adverse reactions
occurring in 2%–5% of patients were eye irritation,
headache, and nasopharyngitis.
INDICATION
ALREX® (loteprednol etabonate ophthalmic
suspension) 0.2% is indicated for temporary relief
of the signs and symptoms of seasonal allergic
conjunctivitis.
can introduce microbes to the ocular
surface, which can lead to other ocular
complications.
IMPACT ON SURGERY
A poor quality tear film from
ocular surface diseases such as allergic
conjunctivitis can affect the accuracy
of preoperative biometry, which in
turn affects IOL power selection in
cataract surgery.6 Without repeatable,
confirmable biometry in our patients, we
set ourselves up for refractive surprises
and postoperative complaints.
A patient with allergic conjunctivitis
will reveal markedly increased tear
levels of proinflammatory cytokines—
inflammatory mediators that can
negatively impact postsurgical healing.5
In addition, the itch associated with
allergic conjunctivitis can provoke eye
rubbing, which not only perpetuates the
inflammatory process but can also lead to
postoperative LASIK flap dislocation.7
Ocular allergy is also a risk factor for
regression and haze after PRK and can
disqualify a patient from LASIK until
symptoms resolve.4,5 Following LASIK
surgery, patients with ocular allergies
are more likely to develop Sands of the
Sahara, or diffuse lamellar keratitis.8
DIAGNOSIS
The most common ocular allergy
complaints are itching and redness,
followed by tearing, lid swelling, and a
grey-white stringy mucous. A history
of severe ocular itching, or a seasonal
itching pattern, almost always indicates
allergic conjunctivitis.
Patients can have a variety of signs,
such as injection, chemosis, conjunctival
chalasis, lid droop, and red, thickened
lids. There is a wealth of information
on examination of the everted upper
tarsus: conjunctival hyperemia, papillae
in the acute phase, follicles in the chronic
phase, conjunctival ulcerations in
extreme cases, and conjunctival scarring
in chronic cases.
RELIEF OF SEVERE OCULAR ITCH
For acute-phase problems, a selective
therapeutic agent with a fast onset of
action such as BEPREVE® (bepotastine
besilate ophthalmic solution) 1.5% is a
good choice.
We also appreciate the comfort
BEPREVE® provides to patients. In a
6-week, double-masked, randomized,
placebo-controlled trial in which 861
patients received BEPREVE® or placebo,
92% of BEPREVE®-treated patients
indicated that they experienced no
discomfort (grade 0) on a 0 to 3 ocular
comfort scale in an analysis of >6400
assessments of both eyes.11
to understand that as their eyecare
practitioner, we are aware of the
therapeutic options available to treat their
condition and have chosen to prescribe
BEPREVE® or ALREX® carefully.
MULTISYMPTOM RELIEF
Figure 1 BEPREVE® is a selective
Blocker of histamine (H1).
BEPREVE®, a selective H1 blocker
(Figure 1), offers relief in minutes, and
has demonstrated efficacy in severe
ocular itch.9 In two double-masked,
randomized, placebo-controlled trials,
68% of BEPREVE®-treated eyes (n = 104
eyes) in patients with severe ocular itch
achieved complete relief of ocular itch vs
3% of placebo treated eyes (n = 98 eyes)
in minutes (P ≤ 0.001).10
Marguerite B. McDonald, MD, is a
Clinical Professor of Ophthalmology at
NYU Langone Medical Center in New
York, NY, an Adjunct Clinical Professor
of Ophthalmology at Tulane University
Health Sciences Center in New Orleans,
and a cornea/refractive surgery/anterior segment specialist
with Ophthalmic Consultants of Long Island in Lynbrook,
NY. Dr. McDonald is a consultant to Bausch + Lomb; the
content of this article is sponsored by Bausch + Lomb.
John D. Sheppard, MD, MMSc, is President
and Managing Partner of Virginia Eye
Consultants, Clinical Director of the
Thomas R. Lee Ocular Pharmacology
Center, and Professor of Ophthalmology,
Microbiology and Molecular Biology at
Eastern Virginia Medical School, and a Medical Director of
the Lions Eye Bank of Eastern Virginia in Norfolk, Virginia.
Dr. Sheppard is a consultant for Bausch + Lomb; the
content of this article is sponsored by Bausch + Lomb.
If the patient presents with more
of a chronic phase, is already on an
antihistamine/mast cell stabilizer, or has
multiple symptoms of seasonal allergic
conjunctivitis, we prescribe ALREX®
(loteprednol etabonate ophthalmic
suspension 0.2%).12
We recommend ALREX® for patients
with seasonal allergic conjunctivitis
because it reduced inflammation and
allergic response quickly and effectively
and has demonstrated efficacy in itching,
burning/stinging, discomfort, foreign body
sensation, tearing, and redness.
In two double-masked, placebocontrolled, six-week environmental studies
conducted during pollen season (N = 268),
ALREX® QID was superior to placebo
QID in treating the signs and symptoms
of seasonal allergic conjunctivitis. ALREX®
provided reduction in bulbar conjunctival
injection and itching, beginning
approximately 2 hours after instillation of
the first dose and throughout the first 14
days of treatment.13,14
In addition, in the two 42-day clinical
trials, 1 out of 133 patients treated with
ALREX® experienced an IOP elevation
≥ 10 mm Hg compared to 1 out of 135
patients treated with placebo.12
ACCESSIBILITY
Thanks to copay assistance programs
from Bausch + Lomb, eligible patients
can limit their copay on either their
BEPREVE® or ALREX® prescriptions.
Often, we can print coupons while
patients are still in the office by going
to Bausch.com. Ask your Bausch +
Lomb Sales Representative for more
information.
Sometimes a patient or pharmacist
will inquire about a generic version of
BEPREVE® or ALREX®. We let them
know that there is no generic equivalent
for either medication. Patients need
Please see Full Prescribing Information for BEPREVE® and Brief Summary of
Prescribing Information for ALREX® on following pages.
REFERENCES
1. Rosario N, Bielory L. Epidemiology of allergic
conjunctivitis. Curr Opin Allergy Clin Immunol.
2011;11:471-6.
2. Bielory L, Katelaris CH, Lightman S, et al.
Treating the ocular component of allergic
rhinoconjunctivitis and related eye disorders.
MedGenMed. 2007;9(3):35.
3. Blaiss MS. Allergic rhinoconjunctivitis: burden
of disease. Allergy Asthma Proc. 2007 Jul-Aug;
28(4):393-7.
4. Yang HY, Fujishima H, Toda I, et al. Allergic
conjunctivitis as a risk factor for regression and
haze after photorefractive keratectomy. Am J
Ophthalmol. 1998 Jan;125(1):54-8.
5. Bielory BP, O’Brien TP. Allergic complications with
laser-assisted in-situ keratomileusis. Curr Opin
Allergy Clin Immunol. 2011 Oct;11(5):483-91.
6. Montes-Mico R. Role of the tear film in the optical
quality of the human eye. J Cataract Refract Surg.
2007;33:1631-5.
7. Padmanabhan P, Aiswaryah R, Abinaya Priya V.
Post-LASIK keratectasia triggered by eye rubbing
and treated with topography-guided ablation and
collagen cross-linking — a case report. Cornea.
2012;31(5):575-80.
8. Boorstein SM, Henk HJ, Elner VM. Atopy: a
patient-specific risk factor for diffuse lamellar
keratitis. Ophthalmology. 2003 Jan;110(1):131-7.
9. BEPREVE [package insert]. Tampa, FL: Bausch &
Lomb Incorporated; 2012. 10. Meier EJ, Torkildsen GL, Gow JA, et al; for
Bepotastine Besilate Ophthalmic Solutions Study
Group. Integrated phase III trials of bepotastine
besilate ophthalmic solution 1.5% for ocular
itching associated with allergic conjunctivitis.
Allergy Asthma Proc. 2012;33:265-274.
11. Data on file. Clinical study report CL-SAF 040507-P. NDA 22-288. Ista Pharmaceuticals, Inc.
October 27, 2008.
12. ALREX [package insert]. Tampa, FL: Bausch &
Lomb Incorporated; 2013. 13. Dell SJ, Lowry GM, Northcutt JA, et al. A
randomized, double-masked, placebo-controlled
parallel study of 0.2% loteprednol etabonate in
patients with seasonal allergic conjunctivitis. J
Allergy Clin Immunol. 1998 Aug;102(2):251-5.
14. Shulman DG, Lothringer LL, Rubin JM, et al. A
randomized, double- masked, placebo-controlled
parallel study of loteprednol etabonate 0.2% in
patients with seasonal allergic conjunctivitis.
Ophthalmology. 1999;106(2):362-369.
15. Kato M, Nishida A, Aga Y, et al.
Pharmacokinetic and pharmacodynamic evaluation
of central effect of the novel antiallergic agent
betotastine besilate. Arzneimittelforschung.
1997;47(10):1116-1124.
16. Hawkins DW, Bussey HI, Trisant LM.
Hypertension. In: Dipiro T, ed. Pharmacotherapy: A
Pathophysiologic Approach. Stamford, CT: Appleton
& Lange; 1997:195-218.
17. Crismon ML, Dorson PG. Schizophrenia.
In: Dipiro T, ed. Pharmacotherapy: A
Pathophysiologic Approach. Stamford, CT: Appleton
& Lange; 1997:1367-1394.
18. Data on file. Bepreve® Integrated Summary
of Safety. NDA 22-288. ISTA Pharmaceuticals, Inc.
October 18, 2008.
®/TM are trademarks of Bausch & Lomb Incorporated or its affiliates.
©2016 Bausch & Lomb Incorporated
BEP.0018.USA.16
BRIEF SUMMARY OF PRESCRIBING INFORMATION
This Brief Summary does not include all the information needed to
use Alrex® (loteprednol etabonate ophthalmic suspension 0.2%)
safely and effectively. See full prescribing information for Alrex.
Alrex
®
loteprednol etabonate
ophthalmic suspension 0.2%
Sterile Ophthalmic Suspension
Rx only
INDICATIONS AND USAGE
ALREX Ophthalmic Suspension is indicated for the temporary relief of the
signs and symptoms of seasonal allergic conjunctivitis.
CONTRAINDICATIONS
ALREX, as with other ophthalmic corticosteroids, is contraindicated in
most viral diseases of the cornea and conjunctiva including epithelial
herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and
also in mycobacterial infection of the eye and fungal diseases of ocular
structures. ALREX is also contraindicated in individuals with known or
suspected hypersensitivity to any of the ingredients of this preparation
and to other corticosteroids.
WARNINGS
Prolonged use of corticosteroids may result in glaucoma with damage
to the optic nerve, defects in visual acuity and fields of vision, and in
posterior subcapsular cataract formation. Steroids should be used with
caution in the presence of glaucoma.
Prolonged use of corticosteroids may suppress the host response and
thus increase the hazard of secondary ocular infections. In those diseases
causing thinning of the cornea or sclera, perforations have been known
to occur with the use of topical steroids. In acute purulent conditions of
the eye, steroids may mask infection or enhance existing infection.
Use of ocular steroids may prolong the course and may exacerbate the
severity of many viral infections of the eye (including herpes simplex).
Employment of a corticosteroid medication in the treatment of patients
with a history of herpes simplex requires great caution.
PRECAUTIONS
General: For ophthalmic use only. The initial prescription and renewal
of the medication order beyond 14 days should be made by a physician
only after examination of the patient with the aid of magnification, such
as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
If signs and symptoms fail to improve after two days, the patient should
be re-evaluated.
If this product is used for 10 days or longer, intraocular pressure should
be monitored.
Fungal infections of the cornea are particularly prone to develop
coincidentally with long-term local steroid application. Fungus invasion
must be considered in any persistent corneal ulceration where a steroid
has been used or is in use. Fungal cultures should be taken when
appropriate.
Information for Patients: This product is sterile when packaged.
Patients should be advised not to allow the dropper tip to touch any
surface, as this may contaminate the suspension. If redness or itching
becomes aggravated, the patient should be advised to consult a
physician.
Patients should be advised not to wear a contact lens if their eye is
red. ALREX should not be used to treat contact lens related irritation.
The preservative in ALREX, benzalkonium chloride, may be absorbed by
soft contact lenses. Patients who wear soft contact lenses and whose
eyes are not red, should be instructed to wait at least ten minutes after
instilling ALREX before they insert their contact lenses.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term
animal studies have not been conducted to evaluate the carcinogenic
potential of loteprednol etabonate. Loteprednol etabonate was not
genotoxic in vitro in the Ames test, the mouse lymphoma tk assay,
or in a chromosome aberration test in human lymphocytes, or in vivo
in the single dose mouse micronucleus assay. Treatment of male and
female rats with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol
etabonate, respectively, (1500 and 750 times the maximum clinical
dose, respectively) prior to and during mating did not impair fertility in
either gender.
Pregnancy: Teratogenic effects: Pregnancy Category C. Loteprednol
etabonate has been shown to be embryotoxic (delayed ossification)
and teratogenic (increased incidence of meningocele, abnormal left
common carotid artery, and limb flexures) when administered orally
to rabbits during organogenesis at a dose of 3 mg/kg/day (85 times
the maximum daily clinical dose), a dose which caused no maternal
toxicity. The no-observed-effect-level (NOEL) for these effects was
0.5 mg/kg/day (15 times the maximum daily clinical dose). Oral
treatment of rats during organogenesis resulted in teratogenicity
(absent innominate artery at ≥5 mg/kg/day doses, and cleft palate
and umbilical hernia at ≥50 mg/kg/day) and embryotoxicity (increased
postimplantation losses at 100 mg/kg/day and decreased fetal body
weight and skeletal ossification with ≥50 mg/kg/day). Treatment of
rats with 0.5 mg/kg/day (15 times the maximum clinical dose) during
organogenesis did not result in any reproductive toxicity. Loteprednol
etabonate was maternally toxic (significantly reduced body weight
gain during treatment) when administered to pregnant rats during
organogenesis at doses of ≥5 mg/kg/day.
Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate
from the start of the fetal period through the end of lactation, a
maternally toxic treatment regimen (significantly decreased body
weight gain), gave rise to decreased growth and survival, and retarded
development in the offspring during lactation; the NOEL for these effects
was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration
of gestation or parturition when administered orally to pregnant rats at
doses up to 50 mg/kg/day during the fetal period.
There are no adequate and well controlled studies in pregnant women.
ALREX Ophthalmic Suspension should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether topical ophthalmic
administration of corticosteroids could result in sufficient systemic
absorption to produce detectable quantities in human milk. Systemic
steroids appear in human milk and could suppress growth, interfere with
endogenous corticosteroid production, or cause other untoward effects.
Caution should be exercised when ALREX is administered to a nursing
woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not
been established.
ADVERSE REACTIONS
Reactions associated with ophthalmic steroids include elevated
intraocular pressure, which may be associated with optic nerve damage,
visual acuity and field defects, posterior subcapsular cataract formation,
secondary ocular infection from pathogens including herpes simplex, and
perforation of the globe where there is thinning of the cornea or sclera.
Ocular adverse reactions occurring in 5-15% of patients treated with
loteprednol etabonate ophthalmic suspension (0.2% - 0.5%) in clinical
studies included abnormal vision/blurring, burning on instillation,
chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching,
injection, and photophobia. Other ocular adverse reactions occurring in
less than 5% of patients include conjunctivitis, corneal abnormalities,
eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort,
papillae, and uveitis. Some of these events were similar to the
underlying ocular disease being studied.
Non-ocular adverse reactions occurred in less than 15% of patients.
These include headache, rhinitis and pharyngitis.
In a summation of controlled, randomized studies of individuals treated
for 28 days or longer with loteprednol etabonate, the incidence of
significant elevation of intraocular pressure (≥10 mm Hg) was 2%
(15/901) among patients receiving loteprednol etabonate, 7% (11/164)
among patients receiving 1% prednisolone acetate and 0.5% (3/583)
among patients receiving placebo. Among the smaller group of patients
who were studied with ALREX, the incidence of clinically significant
increases in IOP (≥10 mm Hg) was 1% (1/133) with ALREX and 1%
(1/135) with placebo.
DOSAGE AND ADMINISTRATION
SHAKE VIGOROUSLY BEFORE USING.
One drop instilled into the affected eye(s) four times daily.
Revised: August 2013.
Bausch & Lomb Incorporated, Tampa, Florida 33637
©Bausch & Lomb Incorporated
Alrex® is a registered trademark of Bausch & Lomb Incorporated
Based on 9007904-9005504
US/ALX/15/0004
Issued: 02/2015
BEPREVE® (bepotastine besilate ophthalmic solution) 1.5%
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information
needed to use BEPREVE® (bepotastine besilate
ophthalmic solution) 1.5% safely and effectively.
See full prescribing information for BEPREVE®.
BEPREVE® (bepotastine besilate ophthalmic
solution) 1.5%
Initial U.S. Approval: 2009
-------------RECENT MAJOR CHANGES-------------Contraindications (4)
06/2012
--------------INDICATIONS AND USAGE-------------BEPREVE® is a histamine H1 receptor antagonist
indicated for the treatment of itching associated
with allergic conjunctivitis. (1)
-----------DOSAGE AND ADMINISTRATION---------Instill one drop into the affected eye(s) twice a day
(BID). (2)
----------DOSAGE FORMS AND STRENGTHS-------Solution containing bepotastine besilate, 1.5%. (3)
-----------------CONTRAINDICATIONS----------------Hypersensitivity to any component of this product. (4)
-----------WARNINGS AND PRECAUTIONS---------t 5 PNJOJNJ[FUIFSJTLPGDPOUBNJOBUJPOEPOPU
touch dropper tip to any surface. Keep bottle
tightly closed when not in use. (5.1)
t #&13&7&TIPVMEOPUCFVTFEUPUSFBUDPOUBDU
lens-related irritation. (5.2)
t 3
FNPWFDPOUBDUMFOTFTQSJPSUPJOTUJMMBUJPOPG
BEPREVE. (5.2)
------------------ADVERSE REACTIONS---------------The most common adverse reaction occurring in
approximately 25% of patients was a mild taste
following instillation. Other adverse reactions
which occurred in 2-5% of subjects were eye
irritation, headache, and nasopharyngitis. (6)
To report SUSPECTED ADVERSE REACTIONS,
contact Bausch & Lomb Incorporated. at 1-800-3230000, or FDA at 1-800-FDA-1088 or www.fda.gov/
medwatch.
See 17 for PATIENT COUNSELING INFORMATION
Revised: 10/2012
FULL PRESCRIBING INFORMATION:
CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Contamination of Tip and Solution
5.2 Contact Lens Use
5.3 Topical Ophthalmic Use Only
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Post-Marketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis and
Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.2 Sterility of Dropper Tip
17.3 Concomitant Use of Contact Lenses
FULL PRESCRIBING INFORMATION
The most common reported adverse reaction
occurring in approximately 25% of subjects was a
mild taste following instillation. Other adverse
reactions occurring in 2-5% of subjects were eye
irritation, headache, and nasopharyngitis.
1 INDICATIONS AND USAGE
solution) 1.5% is a histamine H1 receptor antagonist
indicated for the treatment of itching associated
with signs and symptoms of allergic conjunctivitis.
2 DOSAGE AND ADMINISTRATION
Instill one drop of BEPREVE into the affected
eye(s) twice a day (BID).
3 DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution containing
bepotastine besilate 1.5%.
4 CONTRAINDICATIONS
Bepreve is contraindicated in patients with a
history of hypersensitivity reactions to bepotastine
or any of the other ingredients [see Adverse
Reactions (6.2)].
5 WARNINGS AND PRECAUTIONS
5.1 Contamination of Tip and Solution
To minimize contaminating the dropper tip and
solution, care should be taken not to touch the
eyelids or surrounding areas with the dropper tip
of the bottle. Keep bottle tightly closed when not
in use.
5.2 Contact Lens Use
Patients should be advised not to wear a contact
lens if their eye is red. BEPREVE should not be
used to treat contact lens-related irritation.
BEPREVE should not be instilled while wearing
contact lenses. Remove contact lenses prior to
instillation of BEPREVE. The preservative in
BEPREVE, benzalkonium chloride, may be
absorbed by soft contact lenses. Lenses may be
reinserted after 10 minutes following
administration of BEPREVE.
BEPREVE is for topical ophthalmic use only.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under
widely varying conditions, adverse reaction rates
observed in the clinical trials of a drug cannot be
directly compared to rates in the clinical trials of
another drug and may not reflect the rates
observed in clinical practice.
*Sections or subsections omitted from the full
prescribing information are not listed
6.2 Post Marketing Experience
Hypersensitivity reactions have been reported
rarely during the post-marketing use of BEPREVE.
Because these reactions are reported voluntarily
from a population of unknown size, it is not
always possible to reliably estimate their
frequency or establish a casual relationship to
drug exposure. The hypersensitivity reactions
include itching, body rash, and swelling of lips,
tongue and/or throat.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C: Teratogenicity studies
have been performed in animals. Bepotastine
besilate was not found to be teratogenic in rats
during organogenesis and fetal development at
oral doses up to 200 mg/kg/day (representing a
systemic concentration approximately 3,300 times
that anticipated for topical ocular use in humans),
but did show some potential for causing skeletal
abnormalities at 1,000 mg/kg/day. There were no
teratogenic effects seen in rabbits at oral doses
up to 500 mg/kg/day given during organogenesis
and fetal development (>13,000 times the dose in
humans on a mg/kg basis). Evidence of infertility
was seen in rats given oral bepotastine besilate
1,000 mg/kg/day; however, no evidence of
infertility was observed in rats given 200 mg/kg/
day (approximately 3,300 times the topical ocular
use in humans). The concentration of radiolabeled bepotastine besilate was similar in fetal
liver and maternal blood plasma following a single
3 mg/kg oral dose. The concentration in other
fetal tissues was one-third to one-tenth the
concentration in maternal blood plasma.
An increase in stillborns and decreased growth
and development were observed in pups born
from rats given oral doses of 1,000 mg/kg/day
during perinatal and lactation periods. There
were no observed effects in rats treated with
100 mg/kg/day.
There are no adequate and well-controlled
studies of bepotastine besilate in pregnant
women. Because animal reproduction studies are
not always predictive of human response,
solution) 1.5% should be used during pregnancy
only if the potential benefit justifies the potential
risk to the fetus.
8.3 Nursing Mothers
Following a single 3 mg/kg oral dose of radiolabeled
bepotastine besilate to nursing rats 11 days after
delivery, the maximum concentration of radioactivity
in milk was 0.40 mcg-eq/mL 1 hour after
administration; at 48 hours after administration the
concentration was below detection limits. The milk
concentration was higher than the maternal blood
plasma concentration at each time of measurement.
It is not known if bepotastine besilate is excreted
in human milk. Caution should be exercised when
BEPREVE (bepotastine besilate ophthalmic
solution) 1.5% is administered to a nursing woman.
8.4 Pediatric Use
Safety and efficacy of BEPREVE (bepotastine
besilate ophthalmic solution) 1.5% have not been
established in pediatric patients under 2 years of
age. Efficacy in pediatric patients under 10 years
of age was extrapolated from clinical trials
conducted in pediatric patients greater than 10
years of age and from adults.
8.5 Geriatric Use
No overall difference in safety or effectiveness has
been observed between elderly and younger patients.
11 DESCRIPTION
solution) 1.5% is a sterile, topically administered
drug for ophthalmic use. Each mL of BEPREVE
contains 15 mg bepotastine besilate.
Bepotastine besilate is designated chemically as
(+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1piperidine butyric acid monobenzenesulfonate.
The chemical structure for bepotastine besilate is:
Bepotastine besilate is a white or pale yellowish
crystalline powder. The molecular weight of
®
bepotastine besilate is 547.06 daltons. BEPREVE
ophthalmic solution is supplied as a sterile,
aqueous 1.5% solution, with a pH of 6.8.
The osmolality of BEPREVE (bepotastine besilate
ophthalmic solution) 1.5% is approximately
290 mOsm/kg.
Each mL of BEPREVE® (bepotastine besilate
ophthalmic solution) 1.5% contains:
Active: Bepotastine besilate 15 mg (equivalent to
10.7 mg bepotastine)
Preservative: benzalkonium chloride 0.005%
Inactives: monobasic sodium phosphate
dihydrate, sodium chloride, sodium hydroxide to
adjust pH, and water for injection, USP.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Bepotastine is a topically active, direct H1receptor antagonist and an inhibitor of the release
of histamine from mast cells.
12.3 Pharmacokinetics
Absorption: The extent of systemic exposure to
bepotastine following topical ophthalmic
administration of bepotastine besilate 1% and 1.5%
ophthalmic solutions was evaluated in 12 healthy
adults. Following one drop of 1% or 1.5% bepotastine
besilate ophthalmic solution to both eyes four times
daily (QID) for seven days, bepotastine plasma
concentrations peaked at approximately one to two
hours post-instillation. Maximum plasma
concentration for the 1% and 1.5% strengths were
5.1 ± 2.5 ng/mL and 7.3 ± 1.9 ng/mL, respectively.
Plasma concentration at 24 hours post-instillation
were below the quantifiable limit (2 ng/mL) in 11/12
subjects in the two dose groups.
Distribution: The extent of protein binding of
bepotastine is approximately 55% and
independent of bepotastine concentration.
Metabolism: In vitro metabolism studies with human
liver microsomes demonstrated that bepotastine is
minimally metabolized by CYP450 isozymes.
In vitro studies demonstrated that bepotastine
besilate does not inhibit the metabolism of various
cytochrome P450 substrate via inhibition of
CYP3A4, CYP2C9, and CYP2C19. The effect of
bepotastine besilate on the metabolism of
substrates of CYP1A2, CYP2C8, CYP2D6 was not
studied. Bepotastine besilate has a low potential
for drug interaction via inhibition of CYP3A4,
CYP2C9, and CYP2C19.
Excretion: The main route of elimination of
bepotastine besilate is urinary excretion (with
approximately 75-90% excreted unchanged in urine).
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis and
Impairment of Fertility
Long-term dietary studies in mice and rats were
conducted to evaluate the carcinogenic potential
of bepotastine besilate. Bepotastine besilate did
not significantly induce neoplasms in mice
receiving a nominal dose of up to 200 mg/kg/day
for 21 months or rats receiving a nominal dose of
up to 97 mg/kg/day for 24 months. These dose
levels represent systemic exposures
approximating 350 and 200 times that achieved
with human topical ocular use. The no observable
adverse effect levels for bepotastine besilate
based on nominal dose levels in carcinogenicity
tests were 18.7 to 19.9 mg/kg/day in mice and 9.6
to 9.8 mg/kg/day in rats (representing exposure
margins of approximately 60 and 20 times the
systemic exposure anticipated for topical ocular
use in humans).
There was no evidence of genotoxicity in the
Ames test, in CHO cells (chromosome aberrations),
in mouse hepatocytes (unscheduled DNA
synthesis), or in the mouse micronucleus test.
When oral bepotastine was administered to male
and female rats at doses up to 1,000 mg/kg/day,
there was a slight reduction in fertility index and
surviving fetuses. Infertility was not seen in rats
given 200 mg/kg/day oral bepotastine besilate
(approximately 3,300 times the systemic
concentration anticipated for topical ocular use
in humans).
14 CLINICAL STUDIES
Clinical efficacy was evaluated in 2 conjunctival
allergen challenge (CAC) studies (237 patients).
solution) 1.5% was more effective than its vehicle
for relieving ocular itching induced by an ocular
allergen challenge, both at a CAC 15 minutes postdosing and a CAC 8 hours post dosing of BEPREVE.
The safety of BEPREVE was evaluated in a
randomized clinical study of 861 subjects over a
period of 6 weeks.
16 HOW SUPPLIED/STORAGE AND HANDLING
solution) 1.5% is supplied in a white low density
polyethylene plastic squeeze bottle with a white
controlled dropper tip and a white polypropylene
cap in the following size:
5 mL (NDC 24208-629-02)
10 mL (NDC 24208-629-01)
STORAGE
Store at 15º – 25ºC (59º – 77ºF).
17 PATIENT COUNSELING INFORMATION
For topical ophthalmic administration only.
17.2 Sterility of Dropper Tip
Patients should be advised to not touch dropper tip
to any surface, as this may contaminate the contents.
17.3 Concomitant Use of Contact Lenses
Patients should be advised not to wear a contact
lens if their eye is red. Patients should be advised
that BEPREVE should not be used to treat contact
lens-related irritation.
Patients should also be advised to remove
contact lenses prior to instillation of BEPREVE.
The preservative in BEPREVE, benzalkonium
chloride, may be absorbed by soft contact lenses.
Lenses may be reinserted after 10 minutes
following administration of BEPREVE.
Manufactured by: Bausch & Lomb Incorporated
Tampa, FL 33637
Under license from:
Senju Pharmaceutical Co., Ltd.
Osaka, Japan 541-0046
®/TM are trademarks of Bausch & Lomb
Incorporated or its affiliates
© 2012 Bausch & Lomb Incorporated.
US/BEP/13/0028
4/13
14
clinical diagnosis
Pediatric glaucoma can have
impact beyond clinical effect
Multifaceted approach takes into account psychological, social burdens as children age
By Nancy Groves; Reviewed by Alana L. Grajewski, MD
MIAMI ::
hat happens to children
treated for glaucoma as
they grow older?
The short answer is
that life goes on. Just like
other kids, they want to
be active, get an education, have a career, date, get married, and have
children. But even if their glaucoma has been
followed them, and they have other baggage
that has followed them,” said Alana L. Grajewski, MD.
While the anatomical issues have been well
studied, literature on the psychological-social
burden of childhood glaucoma on children and
families is limited, and these quality of life issues should be examined more formally, she
said, noting that this is one goal of the Childhood Glaucoma Research Network (CGRN),
an international group she helped found several years ago.
Providers need more information on the relationship between the care burden and other
effects of childhood glaucoma, such as depression in caregivers and visually impaired children, she said.
“It should be an essential part of our holistic approach to the management of glaucoma,”
said Dr. Grajewski, director, Samuel and Ethel
Balkan Pediatric International Glaucoma Center, Bascom Palmer Eye Institute, and professor
of ophthalmology, University of Miami Miller
School of Medicine.
She observed that glaucoma experts who
have treated very young children and then continued to follow them for years are uniquely
positioned to understand the importance of
such a multifaceted approach. As part of a
longstanding patient-parent-provider relationship, they have become familiar enough to
be invited to graduations and weddings and
may have fielded questions from now-grown
patients on the risks of inherited glaucoma in
the next generation.
W
Children who have been undergoing treatment or follow-up for years can also share
their experiences with newly diagnosed patients and may be more persuasive than doctors, parents, or coaches in getting them to take
necessary precautions, such as using protective eyewear for sports.
“They know the drill. They’re much more
IMPACT BE YON D
sensitized to knowing that something can hapCLINIC A L FACTOR S
There is also an unmet need for instruments to pen to their eyes,” Dr. Grajewski said.
At some point, patients will “graduate” from
identify the impact of childhood glaucoma bethe care of pediatric providers,
yond the strictly clinical effects.
but young adulthood presents
“We’re looking for ways to
its own concerns, such as decidevaluate this in a more construcAfter childhood
ing whether to have children.
tive fashion: the process, the
glaucoma has
“What do we tell them about
experience, and the outcome
been treated,
genetic testing and the risk for
of the care,” Dr. Grajewski exophthalmologists
their children?” Dr. Grajewski
plained. “All of this you hope
expect to follow
asked. “They may think that they
will reduce the physical, psypatients for years,
and their parents went through
chological, social, and economic
monitoring them for
so much due to the glaucoma
consequences of childhood glaua host of anatomical
that they don’t want to subject
coma for the affected individual
problems that can
children of their own to the same
and the caregiver.”
affect their vision.
thing. It’s our job to be sensiThrough her experience treattive to those things and maybe
ing pediatric glaucoma, Dr. Grastart looking at those issues in
jewski has realized that a teambased approach is most effective and efficient advance or before they leave our care.”
She also noted, however, that the managein providing appropriate care for young patients
ment of pediatric glaucoma can diverge sigand their caregivers.
At the Samuel and Ethel Balkan Interna- nificantly in different countries.
It may be uncommon—for any number of
tional Pediatric Glaucoma Center, glaucoma
specialists partner with experts in pediatric reasons—for children to return to a physician
corneal and retinal diseases and amblyopia or clinic for follow-up visits after their disease
as well as geneticists and genetic counselors has been treated, and in some places growto address children’s needs as they change ing up visually impaired can present many
hardships. ■
through the years.
“All of use who take care of kids see where
having grown up with something that needs
monitoring constantly does affect them, although not necessarily adversely,“ Dr. Grajewski said. “They look back on that experience
and make decisions based on it.”
TAKE-HOME
SUPPORT GROUPS
Dr. Grajewski also recommends support groups
for young glaucoma patients, tailored to different age groups so that they can talk more
freely about the most relevant topics.
Middle-school students, for instance, may
want to trade tips about make-up and dating,
topics their ophthalmologist would never think
of or feel comfortable discussing.
ALANA L. GRAJEWSKI, MD
E: agrajewski@med.miami.edu
This article was adapted from Dr. Grajewski’s presentation at Glaucoma Subspecialty
Day during the 2015 meeting of the American Academy of Ophthalmology. She did not
indicate any proprietary interest in the subject matter.
DUAL-SEGMENT PUMP TECHNOLOGY
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16
clinical diagnosis
In-office therapy may offer MGD relief
Patients must play a role in care; surgeons need a systematic treatment approach
By Vanessa Caceres; Reviewed by Richard S. Davidson, MD
DENVER ::
THOUGH IN-OFFICE treatments for
meibomian gland dysfunction (MGD) can be
helpful, patients also need to know that they
must take a role in managing this chronic condition, said Richard S. Davidson, MD.
Ophthalmologists must also systematically
and consistently follow a treatment plan for patients with MGD to provide relief, explained Dr.
Davidson, associate professor and vice chairman, University of Colorado Health Eye Center, Denver.
A solid treatment approach for MGD is crucial
because the condition may well be the leading
cause of dry eye, Dr. Davidson said. These patients often experience discomfort, and they
make up a significant chunk of office visits.
“We probably all cringe on certain days when
we see another burning, itching patient,” he said.
Additionally, an unhealthy ocular surface different compared with baseline at 3 years,
Dr. Davidson said.
can affect surgical outcomes.
BlephEx is another treatment for patients
At-home treatment has been the mainstay for
MGD, and this has included warm compresses, with MGD and consists of a medical-grade disposable micro-sponge that is
eyelid scrubs and gland expresapplied to the edge of eyelids
sion performed by the patient,
and lashes. The device removes
Dr. Davidson said.
Surgeons have
debris and exfoliates eyelids.
However, these treatments
several in-office
The treatments last about 6 to
come with their own challenges,
treatments available
8 minutes, and patients must
including poor compliance, infor meibomian gland
maintain good eyelid hygiene
adequate heat levels, and padysfunction.
and return for treatment every
tients only able to self-express
4 to 6 months.
the upper portion of the gland.
“In theory, it looks pretty
These challenges have led to
several in-office treatments for blepharitis that good, but there is no data to show it’s beneficial,” Dr. Davidson said.
Dr. Davidson outlined.
A fourth device is a thermoelectric heat pump
One such device that helps with making the
diagnosis is an interferometer (LipiView, Tear- (MiBo ThermoFlo, MiBo Medical Group) that
Science) that takes precise liquefies the meibum and facilitates the expresmeasurements of tear film sion of gland secretions. Heat is applied to the
thickness, takes dynamic outside of the lids, breaking down hardened
CENTURION® VISION SYSTEM
meibomian imaging, and material inside the glands. The treatment takes
IMPORTANT PRODUCT INFORMATION
allows the user to quan- up to 12 minutes each eye. One study showed
CAUTION:
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tify lipid level of tear film. improvement in 73% of patients who had had
environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert® IOL Injector
“This is helpful for an- previous Lipiflow, Dr. Davidson said.
Handpiece does not perform as expected.
Yet another MGD treatment is intense pulsed
alytical
patients because
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you can show them a num- light, for which there is a paucity of published
cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar
data for ophthalmic indications, he said.
ber,” Dr. Davidson said.
coagulation, and intraocular lens injection. The AutoSert® Ζ2/ ΖQMHFWRU +DQGSLHFH LV LQWHQGHG WR GHOLYHU TXDOLHG
AcrySof® intraocular lenses into the eye following cataract removal. The AutoSert® IOL Injector Handpiece achieves the
However, some research has shown a reThe
treatment
arm
of
functionality of injection of intraocular lenses. The AutoSert® IOL Injector Handpiece is indicated for use with the AcrySof®
®
duction
in artificial tear usage, a decrease in
LipiView
is
Lipiflow,
which
lenses SN6OWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof OHQVHVWKDWDUHVSHFLFDOO\LQGLFDWHGIRU
use with this inserter, as indicated in the approved labeling of those lenses.
applies heat to the inner the Ocular Surface Disease Index score, and
WARNINGS:
eyelids. The device liq- a reduction in lid margin edema and vascuAppropriate use of Centurion® Vision System parameters and accessories is important for successful procedures. Use of low
uefies meibomian gland larity. Patients must return for maintenance
YDFXXPOLPLWVORZRZUDWHVORZERWWOHKHLJKWVKLJKSRZHUVHWWLQJVH[WHQGHGSRZHUXVDJHSRZHUXVDJHGXULQJRFFOXVLRQ
FRQGLWLRQVEHHSLQJWRQHVIDLOXUHWRVXɝFLHQWO\DVSLUDWHYLVFRHODVWLFSULRUWRXVLQJSRZHUH[FHVVLYHO\WLJKWLQFLVLRQVDQG
contents and facilitates the treatments every 6 months to a year.
FRPELQDWLRQVRIWKHDERYHDFWLRQVPD\UHVXOWLQVLJQLFDQWWHPSHUDWXUHLQFUHDVHVDWLQFLVLRQVLWHDQGLQVLGHWKHH\HDQGOHDG
Finally, Dr. Davidson addressed intraductal
release of secretion from
WRVHYHUHWKHUPDOH\HWLVVXHGDPDJH*RRGFOLQLFDOSUDFWLFHGLFWDWHVWKHWHVWLQJIRUDGHTXDWHLUULJDWLRQDQGDVSLUDWLRQRZSULRU
to entering the eye. Ensure that tubings are not occluded or pinched during any phase of operation. The consumables used
meibomian
gland probing, in which one study
the
meibomian
glands.
The
in conjunction with ALCON® instrument products constitute a complete surgical system. Use of consumables and handpieces
treatment lasts about 12 reported 96% of the 25 patients included had
RWKHUWKDQWKRVHPDQXIDFWXUHGE\$OFRQPD\DHFWV\VWHPSHUIRUPDQFHDQGFUHDWHSRWHQWLDOKD]DUGV
immediate post-probing relief. However, the
minutes.
AES/COMPLICATIONS:
ΖQDGYHUWHQWDFWXDWLRQRI3ULPHRU7XQHZKLOHDKDQGSLHFHLVLQWKHH\HFDQFUHDWHDKD]DUGRXVFRQGLWLRQWKDWPD\UHVXOWLQ
treatment can be painful, he added.
A
couple
of
studies
have
patient injury. During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip
Dr. Davidson noted one drawback that may
analyzed Lipiflow results,
with a second instrument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the
result of ultrasonic energy causing micro abrasion of the ultrasonic tip.
including one with 40 eyes hurt in-office treatments for MGD is cost and
ATTENTION:
in 20 patients that found reimbursement. ■
Refer to the Directions for Use and Operator’s Manual for a complete listing of indications, warnings, cautions
that meibomian gland seand notes.
cretion scores increased
at 1 month and lasted for
3 years.
RICHARD S. DAVIDSON, MD
Advancing
The
same
study
found
E: Richard.davidson@ucdenver.edu
CATARACT SURGERY
that tear break up time inThis article was adapted from Dr. Davidson’s presentation at Cornea Subspecialty
creased
from
baseline
to
Day
during the 2015 meeting of the American Academy of Ophthalmology. He did not
© 2015 Novartis 7/15 CNT15039JAD-A
1 month but was not that
indicate any proprietary interest in the subject matter.
TAKE-HOME
A dedicated team focused solely on eye care professionals.
An innovative pipeline designed to improve the way you treat.
A shared passion for advancing the field of ophthalmics.
With our unique approach and concierge customer care, Sun Ophthalmics
offers the promise of new beginnings in the ophthalmic landscape.
Be a part of our growing team of world-class professionals.
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Sun Ophthalmics is a subsidiary of Sun Pharmaceutical Industries Ltd.
© 2016 Sun Ophthalmics. All rights reserved. SUN-OPH-FRA-003-1 03/2016
18
STATE-OF-THE-ART
Special Report )
INNOVATION IN IOLS
HOW NEW
‘EVOLVING’
IOL FORMULA
MAXIMIZES LENS
ACCURACY
IOL power (D)
ADVANCES CONTINUE TO PROGRESS FOR PERFORMANCE OF INTRAOCULAR LENS IMPLANTS
Ladas Super Formula represents
novel step forward in IOL calculations
Axial le
ngth (
In developing the “Ladas Super tion and this? How can they deFormula,” the first question we velop intuition?”
Once we could visualize these
asked was: “How do we capture
the best aspects of each formula, formulae in 3-D, we decided to
while minimizing their drawbacks?” use this methodology to compare
IOL formulae with each
We looked at these forother, isolate them and
mulae as the algebraic
join them together, and
equations that they were.
what we ended up with
We wondered what we
was the “Ladas Super
could do by simply graph- By leveraging
Formula” (see Figure 1).
ing these formulae into 3-D mathematical
modeling, clinicians
T he L ada s Super
three dimensions.
James Gleick, the au- are able to understand Formula is a novel approach of taking the
thor of Chaos: Making a modern IOL formulae
ideal portions of curNew Science, said that like never before.
take-home
“graphic images are the
key” and “it’s masochism for a mathematician to do without pictures
… [Otherwise] how can they see
the relationship between that mo-
rent IOL formulae and
stitching them together to create
one amalgamated surface and corresponding formula.
Continues on page 20 : Formula
r (D)
l powe
Cornea
Axial le
ngth (
mm)
r (D)
l powe
Cornea
IOL power (D)
I
n the modern landscape of ophthalmology, there is an abundance of IOL calculation formulae. This often leads to a
clinical dilemma when it comes to choosing the most appropriate option.
Thus far, there did not exist a perfect
formula for all situations, including extremities of
keratometry and axial length.
Since there was no “one” formula, surgeons resorted to
using multiple formulae without a framework to do so.
mm)
IOL power (D)
By Aazim A. Siddiqui MD, Uday Devgan MD, and John G.
Ladas MD, PhD, Special to Ophthalmology Times
Axial le
ngth (
mm)
r (D)
l powe
Cornea
(FIGURE 1) A. Ladas Super Surface in its raw form B. A somewhat amalgamated
Ladas Super Surface C. Fully coalesced Ladas Super Surface (All figures courtesy of
Aazim A. Siddiqui, MD)
Validated
for use with
the UltraSertTM Preloaded IOL Delivery
System*
ProVisc® OVD is
validated for use
with the ORATM
System
EXCEPTIONAL
PERFORMANCE
EVERY STEP
OF THE WAY.
1-3
Your technologies and techniques have
evolved. It’s time to rethink your OVDs.
Trust the industry-leading DuoVisc® OVD system to deliver the
powerful combination of:
• Viscoat
®
OVD with chondroitin sulfate for superior endothelial
protection and retention1-3
• ProVisc
clarity
®
OVD for mechanical protection, space maintenance and
4
Advanced-technology compatibility
Talk to your Alcon sales representative to learn how the
DuoVisc® OVD System can exceed your evolving needs.
DuoVisc
®
VISCOELASTIC SYSTEM
© 2016 Novartis 2/16 US-VIS-16-E-0525
Advancing
CATARACT SURGERY
For important product information, please see adjacent page.
* Speak to your Alcon representative about the appropriate version of UltraSertTM to use with ProVisc
1. Vasavada A, Ong M, Cordova D, Hartzer M. Protective effect ophthalmic viscosurgical devices (OVDs) against hydrogen peroxide-induced oxidative damage to corneal endothelial cells: an in-vitro model. Presented at
American Society of Cataract and Refractive Surgeons; April 3-8, 2009; San Francisco, CA. 2. Petroll WM, Jafari M, Lane SS, Jester JV, Cavanagh HD. Quantitative assessment of ophthalmic viscosurgical device retention using
in vivo confocal microscopy. J Cataract Refract Surg. 2005;31(12):2363-2368. 3. Lindstrom RL, Ong M. Protective effect of OVDs against hydrogen peroxide-induced oxidative damage to corneal endothelial cells: in vitro model.
Presented at ASCRS; 26 Mar 2011; San Diego, CA. 4. DuoVisc® Package Insert.
20
Special Report )
STATE-OF-THE-ART
FORMULA
R E A L-LIFE
EX AMPLES
The Ladas Super Formula automatically eliminates the surgeon’s
need to mull over various formulas
or adjustments. It relies on peerreviewed literature to incorporate
the needed formulae and adjustments to reach the best results to
date, and localizes to the correct
region on the Ladas Super Surface for every individual patient.
Any previously described formula
and any future formula can be
incorporated into the algorithm.
Examples of the Ladas Super
Formula in action are shown in
Figures 2A, 2B, and 2C with a variety of eyes that a surgeon might
come across on a daily basis.
Figure 2A shows the formula
performing with a relatively short
eye. The Ladas Super Formula
INNOVATION IN IOLS
recognizes that the patient has a
short eye, and decides to choose
the appropriate formulae and adjustments to yield the most accurate result.
Figure 2B is a similar example
but showcases a more generic eye
that resembles eyes many surgeons encounter in their operating rooms on a regular basis.
Figure 2C showcases a slightly
longer eye. The Ladas Super Formula sees these eyes and decides
to incorporate necessary adjustments the formulae need to calculate the most accurate result.
The Ladas Super Formula can
be accessed free of charge at www.
iolcalc.com where it is in beta testing. Surgeons are able to perform
lens calculations and provide postoperative data to further hone the
accuracy of the formula.
With the Ladas-Siddiqui graph,
surgeons have the ability to compare multiple formulae to determine where they resemble and
differ from each other at entire
ranges of corneal power and axial
DUOVISC® OVD IMPORTANT PRODUCT INFORMATION
DESCRIPTION: DUOVISC® Viscoelastic System is designed to give two Viscoelastic materials with
different physico-chemical properties that can be used differently and/or sequentially to perform
specific tasks during a cataract procedure. DUOVISC® Viscoelastic System consists of VISCOAT®
Ophthalmic Viscosurgical Device and PROVISC® Ophthalmic Viscosurgical Device. CAUTION:
Federal (USA) law restricts this device to sale by, or on the order of, a physician. DESCRIPTION:
VISCOAT® (Sodium Chondroitin Sulfate – Sodium Hyaluronate) Ophthalmic Viscosurgical Device
INDICATIONS: VISCOAT® OVD is indicated for use as an ophthalmic surgical aid in anterior
segment procedures including cataract extraction and intraocular lens (IOL) implantation. VISCOAT®
OVD maintains a deep anterior chamber during anterior segment surgeries, enhances visualization
during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The
viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation
of a flat chamber during surgery. WARNINGS: Failure to follow assembly instructions or use of an
alternate cannula may result in cannula detachment and potential patient injury. PRECAUTIONS:
Precautions are limited to those normally associated with the surgical procedure being performed.
Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers,
the physician should be aware of the potential allergic risks inherent in the use of any biological
material. ADVERSE REACTIONS: VISCOAT® OVD has been extremely well tolerated in human
and animal studies. A transient rise in intraocular pressure in the early postoperative period may
be expected due to the presence of sodium hyaluronate, which has been shown to effect such a
rise. It is therefore recommended that VISCOAT® OVD be removed from the anterior chamber by
thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases.
Do not overfill anterior chamber. ATTENTION: Please refer to the directions for use for a complete
listing of indications, warnings and precautions. DESCRIPTION: PROVISC® (Sodium Hyaluronate)
Ophthalmic Viscosurgical Device INDICATIONS: PROVISC® OVD is indicated for use as an ophthalmic
surgical aid in the anterior segment during cataract extraction and intraocular lens (IOL) implantation.
Ophthalmic viscoelastics serve to maintain a deep anterior chamber during anterior segment surgery
allowing reduced trauma to the corneal endothelium and surrounding ocular tissues. They help push
back the vitreous face and prevent formation of a flat chamber during surgery. PRECAUTIONS:
Postoperative increases in intraocular pressure have been reported with sodium hyaluronate
products. The IOP should be carefully monitored and appropriate therapy instituted if significant
increases should occur. It is recommended that PROVISC® OVD be removed by irrigation and/or
aspiration at the close of surgery. Do not overfill anterior chamber. Although sodium hyaluronate
is a highly purified biological polymer, the physician should be aware of the potential allergic risks
inherent in the use of any biological material; care should be used in patients with hypersensitivity to
any components in this material. Cannula assembly instructions should be followed to prevent patient
injury. ADVERSE REACTIONS: Postoperative inflammatory reactions such as hypopyon and iritis
have been reported with the use of ophthalmic viscoelastics, as well as incidents of corneal edema,
corneal decompensation, and a transient rise in intraocular pressure. It is therefore recommended
that PROVISC® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration
at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber.
ATTENTION: Please refer to the directions for use for a complete listing of indications, warnings
and precautions.
DuoVisc
®
VISCOELASTIC SYSTEM
Advancing
CATARACT SURGERY
(FIGURE 2) A. The Ladas Super Formula Interface. An example with a short eye
B. An example with a standard eye. C. An example with a somewhat long eye.
length. By doing so, surgeons can
isolate regions of the formulae where
a clinical dilemma may occur.
Surgeons can then target areas
that require the most improvement.
With this graph, surgeons can not
only compare IOL power differences
between formulae, but also various
input parameters, such as anterior
chamber depth (ACD).
Such a task would have taken thou-
sands of eyes to decide upon on a better formula for a given eye. A LadasSiddiqui graph is shown in Figure 3,
where the Ladas Super Formula is
compared with the SRK/T formula.
EVOLUTION OF LADAS
SUPER FORMULA
The key behind the Ladas Super Formula is its potential to limitlessly
improve. The way surgeons go about
21
Special Report )
STATE-OF-THE-ART
INNOVATION IN IOLS
(FIGURE 3) The Ladas-Siddiqui graph. A graphical representation
that highlights areas where the Ladas Super Formula and the SRK/T
formula differ from each other by more than 0.5 D.
improving any formula is to optimize it.
Thomas Olsen, the inventor of the “Olsen
Formula,” has emphasized certain points regarding the optimization of a formula. Optimization is formula-specific and other variables,
such as ACD, can be used to “optimize” a formula—as is shown in his paper on second eyes.1
To improve the Ladas Super Formula, we are
splitting the Ladas Super Surface into tiny “grid
boxes,” which optimizes actual patient data.
We have developed an algorithm that incorporates and analyzes outcome data and adjusts
the surface in all aspects. We have recruited
multiple major cataract and refractive surgery
groups to supply outcome data to aid the optimization process.
Data from these groups is tracked and used
to adjust and optimize the Ladas Super Surface accordingly. Figures 4A and 4B illustrate
the progress made by highlighting the number of eyes we already have for optimization
purposes within each grid box.
This “real-world” data helps the Ladas Super
Formula evolve and gives it a dynamic edge,
which no previous formula had before, to further refine IOL calculations.
In Figures 4A and 4B, we have provided a
distribution of the data already collected over
the given ranges of corneal power and axial
range from various user groups. We can see
there exists a certain preponderance of eyes
in a particular region of the surface.
As we cover every unit of the Ladas Super
Surface, we will continue to optimize and perfect it. The more eyes we are able to gather, the
more refined the Ladas Super Formula gets. We
are crowd-sourcing additional data so we can
move up to a 100,000-plus eyes and eventually
1 million or more eyes. Surgeons can contact
the authors
with the contact information at the end
of this article
i f t he y a re
interested in
participating.
es
Number of ey
≤ 0.5 D Difference
> 05 D Difference
Axial Length (mm)
Super Formula versus SRK/T
D)
r(
Axi
al l
al
eng
th (
e
ow
p
e
orn
mm
C
)
(FIGURE 4A) The Manhattan Graph. A graphical representation of the optimization
efforts so far where the Z-axis represents number of eyes that have been collected
thanks to the participation of user groups.
(FIGURE 4B) A bird’s-eye view of the Manhattan graph.
IMPORTA NCE OF ACD
IN IOL CALCULATIONS
The issue of ACD is an important one when it
comes to IOL calculations.
Parameters, such as axial length and corneal power, have always been related to the
calculation of ACD. By using these methods,
we separate the ACD from the modern IOL
formulae, and figure out the similarities and
differences in various ways ACD is calculated
in these formulae.
This methodology is applied not only to simple IOL calculations, but also to post-refractive
IOL calculations and to accommodating IOLs.
For post-refractive IOL calculations, we essentially can split the ACD from the vergence
calculation of the formulae. We then apply a
double K method to treat the ACD and vergence
calculation separately. It is generally believed
that the ACD calculation is the most critical
step in the calculation of IOL power, especially
in small eyes with short axial lengths.
By leveraging 3-D mathematical modeling,
we are able to understand modern IOL formulae like never before. We also are able to take
the best pieces of all formulae and amalgamate them to create a single, ideal surface and
consequently derive the Ladas Super Formula.
The key functionality of the Ladas Super
Formula concept lies in its innate dynamism,
which leaves room for development of optimization techniques. It is a “living” formula that
is constantly evolving and becoming more accurate as it progresses. By collaborating with
a number of user groups and incorporating
actual patient data, we can adjust every grid
box of the Ladas Super Surface and further
enhance its accuracy. ■
Reference
1. Olsen T. Use of fellow eye data in the calculation
of intraocular lens power for the second eye.
Ophthalmology. 2011;118:1710-1715. doi: 10.1016/j.
ophtha.2011.04.030. Epub 2011 Jul 2.
AAZIM A. SIDDIQUI, MD
P: 703/856-0801
E: aazim.siddiqui@gmail.com,
JOHN G. LADAS, MD, PHD
P: 301/928-1448
E: jladas@marylandeye.com
UDAY DEVGAN, MD
E: devgan@gmail.com
The authors have an ownership interest in the Ladas Super Formula and Ladas Super
Surface and its associated methodologies and processes.
22
Special Report )
STATE-OF-THE-ART
INNOVATION IN IOLS
Newest ICLs associated with low
incidence of cataract formation
Prevalence higher in older patients with high refractive errors, older phakic IOL models
By Lynda Charters; Reviewed by Jose F. Alfonso, MD, PhD
OVIEDO, SPAIN ::
CATARACT FORMATION HAS been center. The mean patient age was
associated with the first phakic IOLs introduced 31.2 years (range, 18 to 50 years).
into the marketplace. However, newer models The mean spherical refractive error
seem to be on the way to solving that prob- was -7.27 (range, -26.5 to 12.5 D).
Of the 3,420 eyes, 1,531 were
lem. The latest models, the Visian Implantable
Collamer Lenses (ICL) (mod- implanted with the V4 phakic IOL,
els V4b and V4c, STAAR Sur- 1,108 with the V4b model, and 781
gical), did not result in cata- with the V4c model. The mean folract development in any eyes low-up times, respectively, were 6
in which they were implanted. years (range, 1 to 12 years), 2 years
Because ICLs meet a need (range, 1 to 3 years), and 6 months
in the refractive surgery arena (range, 3 to 24 months), according
Dr. Alfonso
for patients with high refrac- to Dr. Alfonso, associate professor at the University
tive levels, they have been gainof Oviedo, School of
ing in popularity from more than
Medicine, and head of
just their effectiveness.
The implantation of ICL V4c (pictured above) did not cause any
the Cornea and Lens
In addition, they are safe, precataract formations. (Photo courtesy of Jose F. Alfonso, MD, PhD)
Department, Fernándictable, and provide stable vision
Implantation of the
dez-Vega Universitary
for patients with high levels of mynewest Implantable
reported that central vaulting that exceeded
Institute, Oviedo, Spain.
opia, hyperopia, and astigmatism.
Collamer Lens phakic
He reported that cataracts devel- 90 μm protects against cataract development.
However, the downside has been
intraocular lenses (V4b
However, 150 μm is recommended because
oped in 21 (0.61%) of 15 patients
development of clinically relevant
and V4c) did not cause
with the V4 phakic IOL. No cataof decreased vaulting over time. In a previous
cataracts in 2.1% of patients in less
cataract formation in
racts developed in eyes that received study, Dr. Alfonso and colleagues reported a
than a year following implantation
highly myopic patients.
the other two phakic IOL models. direct relationship between low vaulting and
and in 2.7% before the 3-year mark,
Seven (47%) of the 15 patients cataract formation, with all patients who deaccording to FDA data. The culprit
in the development of anterior subcapsular were younger than 40 years of age and eight veloped cataracts having less than 100 μm of
cataracts seems to be the contact between the (53%) were 40 years and older (mean age, 39.43 vaulting (Graefes Arch Clin Exp Ophthalmol
years). The mean spherical equivalent in these 2010;248:1827-35).
phakic IOL and the natural crystalline lens.
With phakic IOLs with high refractive power,
patients was -10.1 D. In three (14%)
eyes, the phakic IOL power was the peripheral vaulting becomes an issue in
less than -10.5 D, in four (19%) eyes cataract development, and Dr. Alfonso advised
between -10.5 and -13.5 D, and in surgeons to consider this in patients who are
14 (67%) eyes higher than -13.5 D. highly myopic.
In addition, patient age seems to be a factor
The mean vault distance in these
eyes was 103 μm. The mean time in cataract formation, with older patients develto cataract development was 4.2 oping cataracts more often than younger ones.
The authors of this study concluded, “Imyears postoperatively.
The investigators published plantation of the [ICL] phakic IOL led to a very
their findings in the Journal of low incidence of cataract formation. The prev— Jose F. Alfonso, MD, PhD
Cataract and Refractive Surgery alence of cataract was higher in patients who
were older, had high refractive errors, and had
(2015;41:800-805).
The relationship between cataract develop- older phakic IOL models.” ■
In light of this, Jose Alfonso, MD, PhD, and
colleagues, conducted a retrospective, nonran- ment and vaulting has been of interest to surdomized, clinical study in which they evalu- geons. Previous studies have found that there
ated the performances of three phakic IOLs, is substantially less vaulting in patients who
JOSE F. ALFONSO, MD, PHD
the V4, V4b, and V4c models, in 3,420 eyes of are older. A 2003 study by Gonvers and assoE: j.alfonso@fernandez-vega.com
1,898 patients who underwent surgery in one ciates (J Cataract Refract Surg 2003;29:918-924)
Dr. Alfonso did not indicate any proprietary interest in the subject matter.
take-home
‘Previous studies have
found that there is
substantially less vaulting
in patients who are older.’
Once-Daily PAZEOTM Solution
24 HOURS OF OCULAR ALLERGY
ITCH RELIEF
IN ONE DROP
Once-Daily PAZEO™ Solution
for relief of ocular allergy itch:
The first and only FDA-approved once-daily drop with
demonstrated 24-hour ocular allergy itch relief1
Statistically significantly improved relief of ocular itching
compared to PATADAY® (olopatadine hydrochloride
ophthalmic solution) 0.2% at 24 hours post dose
(not statistically significantly different at 30-34 minutes)1
Statistically significantly improved relief of ocular itching
compared to vehicle through 24 hours post dose1
Study design: Two multicenter, randomized, double-masked, parallel-group, vehicle- and
active-controlled studies in patients at least 18 years of age with allergic conjunctivitis using the
conjunctival allergen challenge (CAC) model (N=547). Patients were randomized to receive study
drug or vehicle, 1 drop per eye on each of 2-3 assessment days. On separate days, antigen challenge
was performed at 27 (±1) minutes post dose to assess onset of action, at 16 hours post dose (Study
1 only), and at 24 hours post dose. Itching scores were evaluated using a half-unit scale from
0=none to 4=incapacitating itch, with data collected 3, 5, and 7 minutes after antigen instillation.
The primary objectives were to demonstrate the superiority of PAZEO™ Solution for the treatment
of ocular allergy itch. Study 1: PAZEO™ Solution vs vehicle at onset of action and 16 hours. Study 2:
PAZEO™ Solution vs vehicle at onset of action; PAZEO™ Solution vs PATADAY® Solution, PATANOL®
(olopatadine hydrochloride ophthalmic solution) 0.1%, and vehicle at 24 hours.1-3
PAZEO™ Solution: Safety Profile
Give your patients 24 HOURS
OF OCULAR ALLERGY ITCH
RELIEF with once-daily
PAZEO™ Solution1
Well tolerated1
The safety and effectiveness of PAZEO™ Solution have been established in patients two years of age and older1
The most commonly reported adverse reactions, occurring in 2% to 5% of patients, were blurred vision, dry eye,
superficial punctate keratitis, dysgeusia, and abnormal sensation in eye1
Once-daily dosing1
INDICATION AND DOSING
PAZEO™ Solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis. The recommended dosage
is to instill one drop in each affected eye once a day.
As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to
prevent contaminating the tip and solution. Keep bottle tightly closed when not in use.
Patients should not wear a contact lens if their eye is red. PAZEO™ Solution should not be used to treat contact lens-related
irritation. The preservative in PAZEO™ Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients
who wear soft contact lenses and whose eyes are not red should be instructed to wait at least five minutes after
instilling PAZEO™ Solution before they insert their contact lenses.
The most commonly reported adverse reactions in a clinical study occurred in 2%-5% of patients
treated with either PAZEO™ Solution or vehicle. These events were blurred vision, dry eye,
superficial punctate keratitis, dysgeusia, and abnormal sensation in eye.
For additional information on PAZEO™ Solution, please refer to the brief summary of
the full Prescribing Information on the following page.
References: 1. PAZEO™ Solution Package Insert. 2. Data on file, 2011. 3. Data on file, 2013.
From Alcon, committed to providing treatment options for patients.
Olopatadine is licensed from Kyowa Hakko Kirin Co., Ltd. Japan
©2015 Novartis
6/15
PAZ15093JAD
24
Special Report )
STATE-OF-THE-ART
INNOVATION IN IOLS
Weighing pros, cons of IOL
implantation in pediatric cataract
Study with children under age of 2 finds equal rate of glaucoma but more posterior synechiae
By Vanessa Caceres; Reviewed by Abhay Vasavada, MS, FRCS
AHMEDABAD, INDIA ::
BRIEF SUMMARY
PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7%.
For topical ophthalmic administration.
The following is a brief summary only; see full prescribing
information for complete product information.
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Contamination of Tip and Solution
As with any eye drop, care should be taken not to touch the
eyelids
or surrounding areas with the dropper tip of the bottle to prevent
contaminating the tip and solution. Keep bottle tightly closed
when
not in use.
Contact Lens Use
Patients should not wear a contact lens if their eye is red.
The preservative in PAZEO solution, benzalkonium chloride, may
be absorbed by soft contact lenses. Patients who wear soft
contact
lenses and whose eyes are not red, should be instructed to wait
at least five minutes after instilling PAZEO before they insert their
contact lenses.
ADVERSE REACTIONS
Clinical Trials Experience
Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of
a drug cannot be directly compared to rates in clinical trials of
another drug and may not reflect the rates observed in practice.
In a randomized, double-masked, vehicle-controlled trial, patients
at risk for developing allergic conjunctivitis received one drop
of either PAZEO (N=330) or vehicle (N=169) in both eyes for 6
weeks. The mean age of the population was 32 years (range 2 to
74 years). Thirty-five percent were male. Fifty-three percent had
brown iris color and 23% had blue iris color. The most commonly
reported adverse reactions occurred in 2-5% of patients treated
with either PAZEO or vehicle. These events were blurred vision,
dry eye, superficial punctate keratitis, dysgeusia and abnormal
sensation in eye.
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
There are no adequate or well-controlled studies with PAZEO in
pregnant women. Olopatadine caused maternal toxicity and
embryofetal toxicity in rats at levels 1,080 to 14,400 times the
maximum recommended human ophthalmic dose (MRHOD).
There was no
toxicity in rat offspring at exposures estimated to be 45 to 150
times
that at MRHOD. Olopatadine should be used during pregnancy
only
if the potential benefit justifies the potential risk to the fetus.
Animal Data
In a rabbit embryofetal study, rabbits treated orally at 400 mg/kg/
day during organogenesis showed a decrease in live fetuses. This
dose is 14,400 times the MRHOD, on a mg/m2 basis.
An oral dose of 600 mg/kg/day olopatadine (10,800 times the
MRHOD) was shown to be maternally toxic in rats, producing
death and reduced maternal body weight gain. When
administered to rats throughout organogenesis, olopatadine
produced cleft palate at 60 mg/kg/day (1080 times the MRHOD)
and decreased embryofetal viability and reduced fetal weight
in rats at 600 mg/kg/day. When administered to rats during
late gestation and throughout the lactation period, olopatadine
produced decreased neonatal survival at 60 mg/kg/day and
reduced body weight gain in offspring at 4 mg/kg/day. A dose of
2 mg/kg/day olopatadine produced no toxicity in rat offspring. An
oral dose of
1 mg/kg olopatadine in rats resulted in a range of systemic plasma
area under the curve (AUC) levels that were 45 to 150 times higher
than the observed human exposure [9.7 ng∙hr/mL] following
administration of
the recommended human ophthalmic dose.
Nursing Mothers
Olopatadine has been identified in the milk of nursing rats
following
oral administration. Oral administration of olopatadine doses at
or above 4 mg/kg/day throughout the lactation period produced
decreased body weight gain in rat offspring; a dose of 2 mg/kg/
day olopatadine produced no toxicity. An oral dose of 1 mg/kg
olopatadine in rats resulted in a range of systemic plasma area
under the curve (AUC) levels that were 45 to 150 times higher
than the observed human exposure [9.7 ng∙hr/mL] following
administration of the recommended human ophthalmic dose. It is
not known whether topical ocular administration could result in
sufficient systemic absorption to produce detectable quantities in
the human breast milk. Nevertheless, caution should be exercised
when PAZEO is administered to a nursing mother.
Pediatric Use
The safety and effectiveness of PAZEO have been established in
pediatric patients two years of age and older. Use of PAZEO in
these
pediatric patients is supported by evidence from adequate and
well-controlled studies of PAZEO in adults and an adequate and
well controlled study evaluating the safety of PAZEO in pediatric
and adult patients.
Geriatric Use
No overall differences in safety and effectiveness have been
observed between elderly and younger patients.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity
Olopatadine administered orally was not carcinogenic in mice
and rats in doses up to 500 mg/kg/day and 200 mg/kg/day,
respectively. Based on a 35 μL drop size and a 60 kg person, these
doses are approximately 4,500 and 3,600 times the MRHOD, on a
mg/m2 basis.
Mutagenesis
No mutagenic potential was observed when olopatadine was
tested in an in vitro bacterial reverse mutation (Ames) test, an
in vitro mammalian chromosome aberration assay or an in vivo
mouse micronucleus test.
Impairment of fertility
Olopatadine administered at an oral dose of 400 mg/kg/day
(approximately 7,200 times the MRHOD) produced toxicity in male
and female rats, and resulted in a decrease in the fertility index
and reduced implantation rate. No effects on reproductive
function were observed at 50 mg/kg/day (approximately 900 times
the MRHOD).
PATIENT COUNSELING INFORMATION
H".804+B439&2.3&9.43@);.8*5&9.*3989434994:(-)7455*7
tip to eyelids or surrounding areas, as this may contaminate the
dropper tip and ophthalmic solution.
HB43(42.9&39E8*4+B439&(9C*38*8@);.8*5&9.*39834994<*&7
contact lenses if their eyes are red. Advise patients that PAZEO
should not be used to treat contact lens-related irritation. Advise
patients to remove contact lenses prior to instillation of PAZEO.
The preservative in PAZEO solution, benzalkonium chloride, may
be absorbed by soft contact lenses. Lenses may be reinserted 5
minutes following
administration of PAZEO.
Patents: 8,791,154
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
© 2015 Novartis.
6/15 PAZ15093JAD
IOL IMPLANTATION IN children under
the age of 2 does not always lead to a higher rate
of glaucoma, but posterior synechiae can be more
common, said Abhay Vasavada, MS, FRCS.
Pediatric cataract surgeons most frequently
consider the safety associated with various treatments for pediatric cataract, said Dr. Vasavada,
director, Iladevi Cataract and IOL Research Centre, Ahmedabad, India.
Some studies, such as the Infant Aphakia
Treatment Study, have examined this topic.
Though investigators have focused on unilateral cataract, there is still a need to analyze safety and outcomes in bilateral cataract.
Aphakic glasses can work well, but patients and
their families are seeking alternatives.
“There’s nothing wrong
with glasses, but now that
lifestyles are changing,
those glasses are becoming a handicap,” he said.
IOL implantation
On the surface, it may
was associated with
seem that contact lenses
would be another treat- more inflammation
ment option. However— and slightly more
contact lenses in many visual obscuration in
parts of the world are 120 children age 2 or
expensive and actually younger undergoing
impractical—they need bilateral cataract
a lot of support, Dr. Va- surgery. However, the
rate of glaucoma was
savada said.
For these reasons, more similar compared with
surgeons in centers out- an aphakic group.
side of the United States
are considering IOL implantation. There has been
some hesitation because of concern about the
development of glaucoma.
take-home
TAKING A CLOSER LOOK
In his research, Dr. Vasavada wanted to take a
closer look at outcomes and safety for the treatment of bilateral cataract in patients under the
age of 2. The prospective, randomized, study
analyzed results for up to 5 years and looked at
complications.
The study included 60 eyes with hydrophobic
single-piece IOL implantation and 60 eyes with
aphakia. Dr. Vasavada performed all surgeries.
To help motivate parents and their children
Continues on page 25 : Pros, cons
25
Special Report )
STATE-OF-THE-ART
INNOVATION IN IOLS
Improving cataract surgery cases
in eyes with pseudoexfoliation
Attention to IOL selection among strategies for optimizing success
By Cheryl Guttman Krader; Reviewed by Leonard M. Bley, MD
BROOK LY N, N Y ::
EYES WITH pseudoexfoliation syndrome terial of the enVista IOL will help limit these
(PXF) present multiple challenges for cataract complications, and its performance has been
surgery as they are at increased risk for a num- very promising.”
Dr. Bley said that in eyes with PXF, placeber of complications during and after the procedure. Zonular weakness is a key issue in ment of a capsular tension ring to expand the
these cases as it affects both capsular bag intraoperatively is important for
intraoperative safety and post- increasing the safety of cataract removal in
eyes with frank zonular dehiscence. Leaving
operative IOL stability.
According to Leonard M. the CTR in the eye can also help maintain capBley, MD, multiple features sule stability, although it does not prevent late
of a particular single-piece IOL dislocation.
The benefit of using the enVista
hydrophobic
Dr. Bley
IOL in eyes with PXF relates to the
acrylic IOL (enfact that the lens is constructed of a
Vista, Bausch+Lomb) make it an
relatively stiff hydrophobic acrylic
excellent choice for implantation
material. Consequently, it can act
in eyes with PXF.
Cataract surgery
to keep the capsular bag expanded
Dr. Bley is surgical director, NYL- in eyes with
and help to resist the forces created
ASIK Laser and Microsurgery In- pseudoexfoliation
through capsular bag contraction
stitute, New York, and sees many syndrome is associated
that can lead to zonular dehiscence.
patients of Eastern European and with increased
“Especially in cases where a CTR
Russian heritage among whom PXF intraoperative and
is
not
used, an IOL that is made
is common.
postoperative risks.
After switching to using the en- Strategies for improving of a very stiff material essentially
acts like a CTR to help to keep the
Vista IOL for eyes with PXF about outcomes include
bag open,” Dr. Bley said.
12 months ago, Dr. Bley estimates attention to IOL
The aberration-free aspheric optic
he has implanted it in about 200 selection, and one
of the enVista IOL is another one of
cases either alone or with a capsu- surgeon describes why
its advantages, according to Dr. Bley.
lar tension ring. So far, he is very he is using a particular
He explained this feature makes
satisfied with the outcomes.
IOL.
the optical performance of the lens
“Longer follow-up is needed bemore forgiving to changes in aligncause eyes with PXF are at risk for
late IOL dislocation due to progressive zonu- ment, centration, or axial position that can occur
lar weakness and anterior capsule phimosis,” with time in eyes with PXF considering the pohe said. “However, I believe the unique ma- tential for progressive zonular weakness and
increased risk of capsular phimosis. The potential for late in-the-bag IOL dislocation in eyes
with PXF underlies another reason why Dr. Bley
likes to implant the enVista IOL in these cases.
He explained that the implant features holes at
the junction of the haptic and optic that enable
repositioning by iris or scleral suture fixation.
Careful preoperative examination is important for identifying PXF if it has not been diagnosed already so that surgeons will be prepared to use techniques and technologies that
can reduce the risk of complications.
Dr. Bley said it is important to determine
preoperatively whether the case can be done
with a standard technique or will require placement of a device for capsular support.
“Surgeons should look for movement or shimmering of the lens during the examination in
the office preoperatively, but also need to look
carefully at how the capsule behaves during
capsulotomy,” he said.
Dr. Bley also recommended approaching nucleus
and cortex removal using techniques that will
minimize pressure exerted on the capsular bag.
“It is important to have good hydrodissection
and hydrodelineation, and surgeons might also
consider placing an expansion device or lens
in the bag prior to cortex removal,” he said. ■
PROS, CONS
was essentially the same, Dr. Vasavada said.
However, the difference in the rate of posterior synechiae was significant. ■
take-home
return for numerous follow-up exams, the office helped support their travel.
The study examined glaucoma (defined as
an IOP of more than 21 mm Hg), visual obscuration, and inflammation (e.g., synechiae
and cell deposits). The rate of glaucoma in the
aphakic group was 16.7% and 13.4% in the
pseudophakic group. Visual axis obscuration
was 6.3% in the aphakic group and 10% in
the pseudophakic group. Posterior synechiae
occurred in 10% of aphakic patients and 25%
of pseudophakic patients.
There were also some cell deposits in the
pseudophakic group, but they disappeared after
6 months postoperatively.
The glaucoma rate between the two groups
LEONARD M. BLEY, MD
E: lbley@aol.com
Dr. Bley has no relevant financial interests to disclose.
ABHAY VASAVADA, MS, FRCS
E: icirc@abhayvasavada.com
This article was adapted from Dr. Vasavada’s presentation at the 2015 meeting of the
American Academy of Ophthalmology. He did not indicate any proprietary interest in the
subject matter.
26
Special Report )
STATE-OF-THE-ART
INNOVATION IN IOLS
Phakic IOLs address challenge
of broad range of refractive errors
Current, novel technologies provide good predictability, stable results, good safety profiles
By Lynda Charters; Reviewed by Allon Barsam, MBBS, FRCOphth
LONDON ::
PATIENTS WHO UNDERGO implan-
of the final best spectacle-corrected visual
tation of phakic IOLs to correct high refractive acuity.
errors can gain a number of benefits from this
Finally, patients who underwent phakic
type of surgery. Namely, some preserved accom- IOL implantation had better contrast sensitivmodation and use of surgery that most cataract ity than those who underwent excimer laser
and refractive surgeons find surgery for moderate-to-high myopia and the
familiar, said Allon Barsam, patient satisfaction levels were higher after
MBBS, FRCOphth.
phakic IOL procedures compared with excimer
In addition, the phakic IOL laser procedures, according to Dr. Barsam.
procedure is reversible, there
is lower risk of a retinal deTYPES OF
tachment compared with that
PHAKIC IOLS
Dr. Barsam
associated with refractive lens Among the types of phakic IOLs available,
exchange, the natural corneal shape is pre- the Implantable Collamer Lens (ICL) (Visian
served, and patients with ocular surface dis- ICL, STAAR Surgical) is approved by the
ease are candidates for the surgery.
FDA for the correction of myopia.
This is in contrast to PRK and LASIK, which
It is indicated for implantation in patients
are limited in the degree of refractive errors who are between the ages of 21 and 45 years
that are correctable and have lower
to correct myopia ranging from
predictability and stability levels
3 to 20 D with a maximal level
in patients with high myopia, acof 2.5 D of astigmatism, and the
cording to Dr. Barsam, a consulanterior chamber aqueous depth
tant in cornea, cataract, and remust exceed 2.8 mm.
Phakic IOLs are
fractive surgery, L&D University viable alternatives
In Europe, surgeons can corHospital, UCL Partners, London. for treating high
rect from +21.00 D of hyperopia
However, as with all good refractive errors. The
to -23.0 D of myopia in patients
things, complications are possi- technology provides
with up to 6 D of cylinder.
ble with phakic IOL implantation, good predictability and
“The 3-year outcomes with
such as development of cataracts, stable results, and has
this lens in 526 eyes of 294 paendothelial cell loss, development good safety profiles.
tients were excellent, with 60%
of glaucoma, iris atrophy associof patients achieving an UCVA of
ated with the claw configuration, and trau- 20/20 or better and 95% achieved 20/40 or
matic dislocation, he noted.
better,” Dr. Barsam said. “The lens has good
predictability and low complications rates.”
OUTCOMES
The Verisyse phakic IOL (manufactured
COMPA R ISON
by Ophtec and referred to as Verisyse in the
Dr. Barsam and colleagues compared the out- United States and Artisan in Europe) is an
comes achieved with phakic IOLs with excimer iris claw-fixated phakic IOL that can corlaser procedures in studies that were published rect from -5 to -20 D of myopia with 2.5 D
during the past 10 years.
of astigmatism and higher degrees of myoHe reported that 12 months postoperatively pia, hyperopia, and astigmatism in Europe.
there was no difference between the two sur- A potential concern with this lens is the engeries in the percentages of patients with an dothelial cellular loss over time compared
uncorrected distance visual acuity (UNVA) with the ICL.
of 20/20 or better.
A few improvements in phakic IOL techThe investigators also reported that the nology have been introduced.
phakic IOL procedure was safer for correctA newer ICL model is the V4c, which has
ing moderate to high myopia with less loss an artificial port in the center of the lens
take-home
optic that eliminates the need for a preoperative peripheral laser iridotomy and might
decrease the risks of glaucoma and cataract
development, Dr. Barsam explained.
“This lens is very encouraging,” he noted,
but pointed out that it has not yet received
FDA approval.
A toric ICL and the toric Artisan are currently yielding excellent results. Dr. Barsam
likes these lenses for patients who have more
than 1.5 D of refractive astigmatism.
In addition, these lenses can be used to
treat keratoconus and astigmatism that develops after a corneal graft procedure.
ADDITIONAL
TECHNOLOGY
Novel posterior chamber phakic technology
(IPCL phakic IOL, Care Group India) to correct presbyopia and myopia and astigmatism
has also been recently introduced.
The lens provides near additions ranging
from +1.5 to +3.5 D that can be customized
to the patient’s degree of accommodation.
“It is an interesting lens because it is a
presbyopic ICL that is a reversible solution
for presbyopia in patients aged 40 to 55 years
who have not yet developed cataracts,” Dr.
Barsam said. “There are no long-term results with this lens regarding safety and
efficacy.” ■
ALLON BARSAM, MBBS, FRCOPHTH
E: eyes@allonbarsam.com
This article was adapted from Dr. Barsam’s presentation at Refractive Surgery
Subspecialty Day during the 2015 meeting of the American Academy of Ophthalmology.
Dr. Barsam has no financial interest in the subject matter.
47 ANNUAL
TH
DOHENY DAYS CONFERENCE — JUNE 11, 2016
The Annual Doheny Days Conference hosts presenters from various specialties
disseminating state-of-the-art research findings to improve clinicians’ ability to
better diagnose and manage patients with ocular disease.
The Doheny Memorial Lecturer
The Irvine Memorial Lecturer
DAVID W. PARKE, II, MD
RICHARD K. PARRISH, II, MD
Chief Executive Officer
American Academy of Ophthalmology
San Francisco, California
Professor of Ophthalmology
Associate Dean for Graduate Medical Education
Bascom Palmer Eye Institute
Miami, Florida
R ESERVE YOUR S EAT T ODAY !
Registration fee $100
For more information: www.doheny.org/cme or contact Mary Collins-Smith
cme@doheny.org | 323-442-6427
28
Special Report )
STATE-OF-THE-ART
INNOVATION IN IOLS
Finding ideal mix-match IOL strategy
Combination of low-add multifocal, extended-range-of-vision lens may be solution for many
By Jeffery J. Machat, MD, FRCSC, and Sondra Black, OD, Special to Ophthalmology Times
TORON TO ::
FOR SURGEONS WHO
may have had a bad experience
with earlier multifocal IOLs and
vowed not to implant another presbyopia-correcting lens, times have
changed.
100.0
The latest presbyopia-correcting
92.7
89.0
lenses are not just incrementally
90.0
None
better—they represent a dramatic
Mild/Moderate
80.0
improvement in patient satisfacSevere
70.0
tion, night vision quality, and
(FIGURE
1)
The
beads
on
this
near
reading
card
functional vision. It would be a
55.5
60.0
correspond to 33 cm (+4.00 add), 40 cm (+3.25
mistake not to revisit the cateadd), and 50 cm (+2.75 add). (Figures courtesy of
50.0
gory, especially since surgeons
Jeffery J. Machat, MD, FRCSC, and Sondra Black, OD)
can now mix and match within
40.0
a single lens platform to meet a
30.0
patient’s visual goals.
lenses in the past year, this may
20.0
A variety of mix-and-match strategies have be the best combination avail9.8
been used in the past. Surgeons have tried to able for a full range of vision.
6.1
10.0
combine various multifocal lenses to maxiFor surgeons who do not yet
1.2
1.2
0.0
mize functionality, with limited success. A have access to the Symfony lens,
Halo
Starbursts
year ago, we had been using a combination of the combination of a 2.75-add lens
the Crystalens (Bausch + Lomb) for the dom- in the dominant eye and 3.25(FIGURE 2) Clinical trial results demonstrate that night-vision
inant eye and a Tecnis Multifocal +4.00 add add lens in the non-dominant
symptoms are mainly mild to nonexistent.
(Abbott Medical Optics) for the non-dominant eye could achieve similar results.
eye, to give patients both reading and intermediate vision, as well as their distance. Both of
GET TING BACK
tasks to guide the decision of what to implant
these lenses had significant drawbacks, though.
I N T O M I X-A N D - M AT C H
in the second eye. If the patient is already satNow, two lenses that have recently been in- A surgeon who may be apprehensive about isfied with near vision, put the same lens in
troduced to market—the Tecnis Multifocal low getting back into multifocal IOL implantation the second eye. If he or she wants better near,
add and the Tecnis Symfony extended range might want to start with bilateral implanta- choose a higher add (3.25) for the second eye.
of vision IOL (Abbott Medical Optics)—seem tion of the Tecnis Multifocal 2.75 add or the
There is exponentially less chance of havto provide the ideal combination.
ReStor 2.5 add.
ing a patient who is unhappy with results if
When the Symfony lens was introduced in
These low-add lenses are well tolerated, and the surgeon starts with low-add (2.75) or SymCanada, we began implanting it bilaterally, they provide good distance vision and practi- fony lenses and adjusts from there to achieve
with great results. It provides about 1.5 D of cal intermediate.
the functional range of vision that meets the
accommodative amplitude, so patients could
Depending on the patient, they may provide patient’s needs.
be counseled to expect to use a pair of +1.00 sufficient reading vision, as well. It is a good
readers for small print.
segue into other combinations. PaNIGHT VISION
Then, we began trying to give
tients will also experience less halo Another concern with earlier presbyopic lenses
patients a “boost” for their near viand glare than with the higher-add was the potential for nighttime dysphotopsias.
sion by implanting a Symfony lens
multifocal lenses. It is a clinically With a +4.00 add, when the patient focuses on
in the dominant eye for intermedisignificant improvement.
distance, the reading vision is out of focus. The
ate and a +3.25 low-add multifocal
The
best
way
to
start
mixing
and
difference between the distance and the near
Two clinicians explore
in the non-dominant eye for near. why an optimal visual
matching is to implant a Symfony focal points is so large that there is a large blur
Both eyes, together or individually, solution for patients
or low-add lens (2.75) in the domi- circle, which is what causes halo and glare.
see really well at distance.
nant eye first. At the 1-week postWith a low-add lens, the blur circle is smaller.
may be using both a
A prospective study of outcomes low-add multifocal and
operative visit, use the patient’s as- While halos and glare may still be present, they
with this combination is under way, an extended-range-ofsessment of how he or she is func- are much less bothersome and patients seem to
but after implanting 800 of these vision lens.
tioning for near and intermediate tolerate these low-add multifocal IOLs better.
Percentage of Subjects
Night Vision Symptoms Reported
with Tecnis Symfony IOL
Harmony EMEA Trial
take-home
29
Special Report )
4 Steps to
Mix and Match
Questionnaire/good history. Patients’ responses
will indicate whether they want to be completely
spectacle independent or are willing to wear glasses
at some distances; what activities they do regularly;
and how much of a perfectionist they are.
1
Astigmatism. Visually significant astigmatism affects options. New low-add and extended rangeof-vision lenses do not come in a toric option yet
so it will be necessary to correct the astigmatism
with femtosecond arcuate incisions, manual LRIs,
or laser vision correction if the patient wants presbyopia correction.
2
Physical size. Take into consideration whether the
person is short or tall and has long or average
length arms. A tall man with long arms may do best
with Symfony in both eyes.
3
Near preference. During the preoperative workup,
patients are given a reading card and asked: “In
an ideal world, where do you want to read?” The
reading card has a string with colored beads at 33
cm (to correspond to a +4.00 add), 40 cm (+3.25
add), and 50 cm (+2.75 add). Present the reading
card upside down. When patients flip it right side up,
they will naturally adjust it to their reading distance.
If a reading distance of 40 cm, the Symfony/+3.25
add combination is likely ideal.
No matter what lens is chosen, surgeons do not
make a promise for 100% spectacle independence, and
still tell patients to expect to need a pair of reading
glasses for threading a needle or reading fine print.
4
The Symfony design goes even further toward eliminating night-vision problems. It has
an echelette design in which each ring has
increasing foci. This provides a continuous
curve rather than two distinct focal point peaks.
Patients can hold something at intermediate
range and bring it in closer while continuing
to read with ease, which is a more natural visual experience. Clinical trial results demonstrate that night-vision symptoms are mild to
nonexistent.
Because of these important improvements
in lens quality and functionality, surgeon confidence in and market penetration of presbyopia-correcting IOLs should significantly increase over the next 2 to 3 years.
It cannot be stressed enough the difference
between low- and high-add multifocal lenses.
STATE-OF-THE-ART
INNOVATION IN IOLS
Anyone who begins implanting low-add multifocal IOLs and talking to patients postoperatively about the experience will realize how
much better they are. The add powers can
already be mixed and matched to achieve an
excellent range of vision and high satisfaction
for most patients. Where the Symfony lens is
available, the combination of it with a low-add
multifocal may be ideal. ■
V is it
JEFFERY J. MACHAT, MD, FRCSC
Dr. Machat is chief medical officer, Crystal Clear Vision, Toronto.
He is a consultant/researcher/investigator for Abbott Medical Optics.
SONDRA BLACK, OD
Dr. Black is vice president and clinical director, Crystal Clear Vision.
She is a consultant for Abbott Medical Optics.
us at
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30
Special Report )
STATE-OF-THE-ART
INNOVATION IN IOLS
Novel optic designs drive presbyopiacorrecting IOL technology
Continuous range of vision serves as focus without limitations of bifocal multifocal lenses
By Cheryl Guttman Krader; Reviewed by Boris Malyugin, MD, PhD
MOSCOW ::
THE LIMITATIONS of bifocality for providing a full range of good uncorrected vision
have driven the development of novel optic designs in presbyopia-correcting IOL technology,
said Boris Malyugin, MD, PhD.
Trends in Europe—where
a variety of such implants is
available—show surgeons
are favoring trifocal designs
over IOLs producing only two
areas of focus, and use of a
low-add multifocal IOL is gainDr. Malyugin
ing popularity.
In addition, when used in a micromonovision approach, extended range of vision and
extended depth of field IOLs seem to be providing good functional vision at near, intermediate, and far with reduced risk of dysphotopsias. Results with small-aperture IOLs are
promising, but more data are needed, Dr. Malyugin noted.
“In the future we will likely see further developments in multifocal optics for pseudophakic IOLs,” said Dr. Malyugin, professor of
ophthalmology, and deputy director general
(R&D, Edu), S. Fyodorov Eye Microsurgery State
Institution, Moscow. “However, these lenses
may have almost reached their physical limits
because loss of contrast sensitivity and quality of vision continue to be issues.”
Meditec) are also available in Europe.
Data published in the peer-review literature
show that compared with bifocal IOLs, the trifocal design provides better intermediate vision
while maintaining good vision at far and near.
In addition, results of a study comparing the
first two trifocal IOLs showed no significant
differences between them, Dr. Malyugin said.
However, there is also evidence that unwanted visual symptoms, particularly glare,
ghosting, halos, and problems with night driving, still occur with trifocal IOLs.
“Trifocal IOLs are unlikely to be worse than
bifocal IOLs in generating unwanted optical
phenomenon,” Dr. Malyugin said. “However,
surgeons should still warn patients about the
potential for halos and other symptoms after
surgery.”
Extended depth of focus or extended range
of vision IOLs represent another type of presbyopia-correcting technology. Graham Barrett,
MD, pioneered the concept for this design and
there are now two lenses in this category. The
first on the market features an aspheric design
that provides a controlled amount of spherical
aberration (EDF, Hoya).
The other product, an extended range of
vision IOL (Tecnis Symfony, Abbott Medical
Optics), uses a combination of optics designs
for elongating the depth of focus and correcting chromatic aberration and also incorporates
spherical aberration correction.
UPDATE ON TECHNOLOGY
Data published in the peer-review literature
Dr. Malyugin said the idea of a trifocal IOL
was first introduced in Russia by the local on the first extended depth of focus IOL show
hydrophobic IOL manufacturer “Reper-NN.” that it provides visual quality outcomes simiHowever, the design of the diffractive part of lar to those associated with prior multifocal
the lens optic, which had square elements, IOL technology and that modest monovision
is needed for optimizing near UCVA.
was not optimal.
Dr. Malyugin said he was not
Subsequently, a trifocal implant
aware of any papers published in
(FineVision, PhysIOL) based on the
the peer reviewed literature reportpatented design of a research group
ing clinical outcomes achieved with
headed by Damien Gatinel, MD, was
the extended range of vision IOL.
launched in March 2010. Currently,
New IOLs based on a
Small-aperture IOLs represent
two other trifocal IOLs, each with
another approach for enhancing
different design characteristics, as variety of optic designs
depth of focus, and two such imwell as toric versions of trifocal are aiming to provide
plants are available.
IOLs (FineVision Toric, PhysIOL; presbyopic correction
One lens (IC-8TM, AcuFocus),
AT Lisa tri toric 939MP, Carl Zeiss for pseudophakia.
take-home
1st Trifocal IOL optic
design by REPER-NN
Material
foldable hydrophobic acrylic
Refractive index
1.505
Optical diameter
6.0 mm
Total Diameter
12.5 mm
Central diffractive zone
3.4 mm
Diffractive near addition +4.0D
(FIGURE 1) The first trifocal IOL introduced in
Russia was designed with square elements in
the diffractive part of the lens optic. Subsequent
lenses have improved in their designs. (Figure
courtesy of Boris Malyugin, MD, PhD)
developed by the same manufacturer that is
marketing the small-aperture corneal inlay
(KAMRA, AcuFocus), is a single-piece hydrophobic acrylic lens with an aspheric optic and
centrally located opaque annular mask that is
implanted in the non-dominant eye. Data from
a series of 11 patients show this approach provided a continuous broad range of vision with
excellent visual acuity across all distances.
A second small-aperture IOL made of hydrophobic acrylic is designed for implantation
in the ciliary sulcus and acts via a pinhole
mechanism to increase depth of focus (Xtra
Focus, Morcher).
Reported outcomes with this technology show
that it improved vision in eyes with irregular
corneal astigmatism after corneal transplantation, but it can also be used to extend the
depth of focus in normal pseudophakic eyes,
Dr. Malyugin said.
31
Special Report )
M U LT IFOC A L DE SIGNS
Other new concepts in presbyopia-correcting
IOLs include novel multifocal designs described
as zonal refractive, rotationally asymmetric, inferior segmental addition, and sectorial addition.
One such lens featuring a refractive section
that directs light to another focal point on the
retina (Lentis Mplus, Oculentis) is similar to
existing multifocal IOL technology for providing
STATE-OF-THE-ART
INNOVATION IN IOLS
good uncorrected visual acuity at near and far.
A low near-add IOL with +1.5 D near add
power (Lentis comfort, Oculentis) seems to provide good intermediate uncorrected vision and
can be used with a micromonovision approach.
A supplementary sulcus-fixated multifocal
IOL (Sulcoflex Multifocal 653F, Rayner) has
been shown to improve near vision and is reversible if the patient is not satisfied with it. ■
BORIS MALYUGIN, MD, PHD
E: boris.malyugin@gmail.com
This article was adapted from Dr. Malyugin’s presentation at Refractive Surgery
Subspecialty Day during the 2015 meeting of the American Academy of Ophthalmology.
Dr. Malyugin does not have any financial interests relevant to the subject matter. He
acknowledges consulting services for Alcon Laboratories, Bausch + Lomb, and Carl
Zeiss Meditec.
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32
Special Report )
STATE-OF-THE-ART
INNOVATION IN IOLS
Comparing intraoperative
aberrometry, toric IOL calculator
Intraoperative aberrometry reduces residual astigmatism in patients with high astigmatism
By Vanessa Caceres; Reviewed by Robert J. Cionni, MD
Postoperative Refractive Astigmatism
at 1 Month
100
Toric Calculator
90
Mean (SD) 1-Month Postoperative
Astigmatism
Intraoperative Aberrometer
1.0
85.4
0.9
80
0.8
p=0.002
0.7
55.5
50
Diopters
Percentage of eyes
70
60
±0.36
44.5
Dr. Cionni
40
±0.28
0.6
0.52
0.5
0.4
p=0.001
30
0.29
0.3
20
14.6
10
0.2
0.1
0
0
≤0.5 D
Toric Calculator
>0.5 D
Intraoperative Aberrometer
SD, standard deviation
(FIGURE 1) Left: The number of subjects falling outside of the 0.5D threshold was 29.9% lower for the cases using the intraoperative aberrometer.
Right: The mean residual astigmatism in the intraoperative aberrometry group was 0.28 D, compared with 0.36 D in the toric calculator group.
(Figures courtesy of Robert J. Cionni, MD)
SALT L AK E CI T Y ::
THE USE OF INTRAOPERATIVE
results, including best-corrected distance viaberrometry during cataract surgery decreased sual acuity and manifest refraction, and postthe amount of residual astigmatism in a group operative astigmatism at 1 month after cataof patients with high astigmatism, said Robert ract removal and toric IOL implantation (AcrySof, Alcon). This particular study
J. Cionni, MD.
was part of a larger study that inThe randomized, observercluded T3 to T7 toric IOL models,
masked study led by Dr. Cionni
but this subset only included T5
included 45 subjects (90 eyes) with
to T7 models.
high astigmatism. Dr. Cionni is medThe use of
There were the standard incluical director, The Eye Institute of intraoperative
sion
and exclusion criteria. No eyes
Utah, Salt Lake City.
aberrometry led to
with corneal abnormalities, such
Investigators randomly assigned better outcomes in a
as ectasia, were allowed, Dr. Cieyes to the use of intraoperative group of post-cataract
onni said.
aberrometry (ORA, Alcon Labo- surgery eyes with high
“Results showed a significant
ratories) to provide aphakic and astigmatism.
difference between the two groups,
pseudophakic data and guide the
surgeon in IOL selection or a toric IOL calcula- with results that favored intraoperative abertor. Subsequently, the fellow eye was randomly rometry,” Dr. Cionni said.
Slightly more than 85% of eyes in the inassigned to the opposite group.
Study investigators examined visual acuity traoperative aberrometry group had 0.5 D or
take-home
less of astigmatism at 1 month compared with
55.5% in eyes in the toric IOL calculator group.
The mean residual astigmatism in the intraoperative aberrometry group was 0.28 D, compared with 0.36 D in the toric calculator group.
The use of intraoperative aberrometry also
changed the recommended toric magnitude in
56% of eyes in that group. Many eyes required
a decrease in IOL power magnitude while three
eyes had an increase in IOL power magnitude,
Dr. Cionni said.
Although some of the IOL power differences
may seem small, even small differences can
affect visual acuity, he said.
C A SE ST U DY
In one typical case study, a 69-year-old subject received a T5 lens in both eyes. His left
eye, which had intraoperative aberrometry performed, was operated on first. Then, a toric
33
Special Report )
IOL calculator was used with the right eye.
Investigators measured 1 D less corneal astigmatism than planned in the right eye, and therefore a T3 lens was implanted instead of a T5.
The patient’s uncorrected visual acuity in
the toric IOL calculator eye was 20/25, compared with 20/20 in the eye in which intraoperative aberrometry was used.
STATE-OF-THE-ART
INNOVATION IN IOLS
The study showed less residual astigmatism
in eyes in which intraoperative aberrometry
had been used.
“For this group of patients with higher astigmatism, intraoperative aberrometry had a higher
percentage of eyes with 0.5 D or less of astigmatism and a lower mean postoperative astigmatism,” Dr. Cionni said. ■
ROBERT J. CIONNI, MD
E: rcionni@theeyeinstitute.com
This article was adapted from Dr. Cionni’s presentation at the 2015 meeting of the
American Academy of Ophthalmology. Dr. Cionni is a consultant and lecturer for Alcon
Laboratories.
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drug therapy
Novel dry eye therapy shows
efficacy, rapid onset of action
Nanomicellar cyclosporine formula may expand options; long-term safety to be studied
By Lynda Charters; Reviewed by Joseph Martel, MD
EL K GROVE, CA ::
newly developed drug for treating dry eye (OTX-101; Seciera,
Auven Therapeutics) seems to
be a potential beneficial therapy
based on the results of a phase
IIb/III clinical trial in which the
safety and efficacy of the formulation were evaluated.
Results showed that the two concentrations
of the drug were well tolerated and patients
had improved tear production and less inflammation by 12 weeks. The future introduction
of a new dry eye formulation would be a welcome addition considering the high frequency
with which dry eye occurs, according to Joseph Martel, MD.
Up to 40% of all visits to ophthalmologists
are scheduled because patients are seeking
help for dry eye symptoms, he noted.
“Ten to 15 million patients in the United
States have dry eye and Sjorgen’s syndrome,
the latter of which is associated with dry eye,
dry mouth, and inflamed joints, and develops
in 1% of the population,” said Dr. Martel, director, Department of Ophthalmology, California
Northstate College of Medicine, Elk Grove, CA.
“Dry eye is a painful, debilitating disease.”
A number of dry eye therapies have become
commercially available recently. However, many
of the dry eye drops are palliative and do not
address the disease. The efficacy with cyclosporine ophthalmic emulsion 0.05% (Restasis,
Allergan) helps some, but many patients cannot
tolerate it due to burning and irritation upon
instillation, which reduces patient compliance.
Currently, this suggested there is a large
number of a patient without effective treatment.
The manufacturer describes OTX-101 as a
novel patented nanomicellar formulation of
unpreserved cyclosporine that in animal studies of New Zealand rabbits exhibited superior
ocular tolerability to that of cyclosporine A. In
that study, the tissue distribution of the drug
in the cornea and superior bulbar conjunctiva was greater when compared with that of
cyclosporine A.
A
Shirmer's Test
— Responder Analysis
20%
Propertion of subjects with ≥10 mm improvement
34
p-value versus vehicle
C-M-H test, 2-tailed
p=0.007
17.9%
15%
13.3%
10%
5%
7.6%
0%
Vehicle
Seciera 0.05%
Seciera 0.09%
(FIGURE 1) A higher proportion of patients treated with the 0.09% drug concentration (17.9%) experienced
a 10 mm or greater improvement for Schirmer’s test compared with only 7.6% of patients receiving vehicle
(p = 0.007). (Source: Auven Therapeutics)
rolled, 426 completed the study, in the three
PHASE IIB/III FINDINGS
The trial had a multicenter, double-masked, groups, 144, 142, and 140, respectively.
Investigators reported that both drug conparallel group design with three treatment
arms: vehicle (n = 152) and two doses of the centrations were superior to the vehicle at
cyclosporine nanomicellar solution, 0.05% all time points when analyzing the changes
in conjunctival staining from
and 0.09% (n = 151 and n =
baseline (0.05% concentration,
152, respectively).
p = 0.006; and 0.09% concenAfter a 2-week vehicle run-in
The efficacy of
tration, p = 0.008, compared
period, patients were treated
a novel dry eye
with the vehicle).
for 12 weeks. Patients were
therapeutic may
Both concentrations also
not permitted to use artificial
bring a valuable
were superior to the vehicle
tears during the study, which
addition to the dry
in total and inferior corneal
was conducted at 29 sites in
eye armamentarium
fluorescein staining at the final
the United States.
with a rapid onset
evaluation. Tear production was
Primary efficacy endpoints
of action and better
superior with both concentrawere conjunctival staining and
patient tolerability.
tions of the active treatment
the SANDE (Symptom Assesscompared with the vehicle.
ment iN Dry Eye) score. SecA higher proportion of paondary efficacy endpoints were
corneal staining, tear film break-up time, and tients treated with the 0.09% drug concentraSchirmer’s test results. Of the patients en- tion (17.9%) experienced a 10 mm or greater
TAKE-HOME
drug therapy
improvement for Schirmer’s test compared with
only 7.6% of patients receiving vehicle (p =
0.007).
Regarding the SANDE score, the three study
arms showed an approximate 30% improvement
in symptoms over the study course.
PE R F OR M A N C E A N A LY S I S
The agent seemed to perform well in the central
cornea, which is the area that the FDA considers to have the greatest clinical relevance, Dr.
Martel noted.
In contrast, the OPUS-1 study of lifitegrast
(Shire Pharmaceuticals) showed that compared
with placebo, lifitegrast did not differ significantly from that of placebo in central corneal
staining but did differ significantly inferiorly
and superiorly. The OPUS-2 and -3 studies of the
drug did not show a trend toward significance
in inferior corneal staining when the changes
from baseline were evaluated.
The most commonly reported adverse effect
with OTX-101 and cyclosporine is burning upon
instillation of the drops, which can affect patient
compliance. With cyclosporine, about 17% of
patients assigned to the 0.05% and 0.1% concentrations of cyclosporine A reported burning
on instillation.
In contrast, 1.3% of patients assigned to
both OTX-101 concentrations reported severe
discomfort.
In addition, the increased tear production
with OTX-101 was seen at 12 weeks compared
with that of cyclosporine, which the FDA approved based on increased tear production after
6 months.
“It is gratifying to see that [OTX-101] is so
well tolerated and may soon provide our patients with dry eyes another clinically proven
effective treatment,” Dr. Martel said. “I have
been very impressed with its clinical efficacy.”
The FDA directed that one phase III trial be
conducted to confirm the significant increase
in tear production and the significant decrease
in inflammation of the ocular surface compared
with placebo resulting from instillation of OTX101 in the phase IIb/III clinical trial.
This confirmatory study has begun, according to a March 3 statement issued by Auven
Therapeutics.
A long-term safety study will be conducted
concurrently. The manufacturer anticipates that
if these studies are successful, a new drug application will be submitted in 2017. ■
35
‘It is gratifying to see that [OTX-101] is
so well tolerated and may soon provide
our patients with dry eyes another clinically
proven effective treatment.’ — Joseph Martel, MD
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36
technology
Retinal exam brings diabetic
retinopathy screening to PCPs
System aims to enhance low screening rates, improve access of care, increase quality outcomes
By Vanessa Caceres; Reviewed by Yvonne I. Chu, MD, MBA, and Sunil Gupta, MD
t is no secret that a diabetes epidemic
exists in the United States. A 2014 report
from the Centers for Disease Control
and Prevention states that 29.1 million
Americans have diabetes—or a little more
than 9% of the total U.S. population.
Almost one-third of those with diabetes are undiagnosed, according to the report.
With the possible damaging effects on the
eyes, not to mention the rest of the body, it
has been a challenge for eye-care professionals
(ECPs) to reach those with diabetes for a recommended annual exam. Pensacola, FL-based
Intelligent Retinal Imaging Systems (IRIS) is
changing that by providing access for diabetic
patients to complete their annual retinal exams
in the primary-care physician (PCP) office.
The company’s retinal exam system integrates into the electronic medical record and
identifies patients who need the test performed.
At the primary-care office, staff uses IRIS to
capture images of the patient’s eye, adding
about 5 minutes on to an existing appointment. Then, the images are interpreted by an
ophthalmologist or retina subspecialist.
Sometimes, the eye specialist interpreting
an image is already based in the same local
area as the PCP and IRIS helps to bring them
together virtually using the IRIS Cloud which
stores the retina images, said Jason Crawford,
IRIS chief executive officer.
Other times, a larger health-delivery system may incorporate its own eye specialists
already within their system to interpret those
images, like at the Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami.
Yet, a third scenario is that physicians who
are part of the IRIS Reading Center will interpret the images. These readers are contracted
by IRIS and provide the interpretation via the
IRIS Reading Center. The Harris Health System, the public safety net for Harris County
in Houston, uses this model in collaboration
with the Department of Ophthalmology at
Baylor College of Medicine and University of
Texas-Health.
I
The retinal exam system aims to
address low screening rates for
diabetic retinopathy. The purpose
of the technology is to reach as
early as possible the patients with
diabetes who would not otherwise
go for an annual eye exam,
according to Sunil Gupta, MD,
chief medical officer of IRIS.
(Photo courtesy of Intelligent Retinal Imaging
Systems)
Patients with suspicious pathology—be it
diabetic retinopathy, glaucoma, cataract, or an
epiretinal membrane—are guided to follow up
with an ophthalmologist or retinal specialist
for further care.
“Our system reaches those patients who do
not currently seek eye care and encourages
them to establish care,” Crawford said.
The purpose of IRIS is to reach as early as
possible the patients with diabetes who would
not otherwise go for an annual eye exam, said
Sunil Gupta, MD, chief medical officer of IRIS. Dr. Gupta
started the company in 2011.
“In some parts of the country, only 30% to 40% have
that annual exam,” Dr. Gupta
said. “For whatever reason,
Dr. Gupta
it doesn’t happen, maybe because they aren’t symptomatic until they have
significant vision loss.”
By reaching these patients earlier, eye problems are usually less severe, and patient care
costs are lower, Dr. Gupta said. Better visual
outcomes also are more likely.
This is why the idea of implementing IRIS
within a PCP’s office seemed to work most
effectively, as those with diabetes will make
more of an effort to see their primary-care office, Dr. Gupta said.
OPHTHALMOLOGIST’S ROLE
One point that both Dr. Gupta and Crawford
want to make clear is that IRIS is not a system
that will take patients away from ophthalmologists. In fact, they say the system actually
provides additional patients for eye-care specialists—and it gets the patients to them who
have the most acute pathology. One in eight of
the patients with diabetes who are examined
have sight-threatening disease.
IRIS works with primary-care providers to
set up a system for referral to local ECPs. At
systems like Harris Health, there’s already a
connection with physicians from Baylor College of Medicine and University of Texas.
“Their ophthalmologists and optometrists
have been able to take these patients and manage them,” Dr. Gupta said.
Yvonne I. Chu, MD, MBA, chief of Ophthalmology Service, Ben Taub Hospital, Harris Health
System, and associate professor at Baylor College of Medicine, said Harris Health decided
to invest in IRIS in 2013 because leaders at the
system wanted to do a better job of managing
care for those with diabetes.
technology
They purchased eight systems and ments the patients risk complications.
“After the patient, the insurance
strategically placed them at different
Harris Health Community Clinic loca- payers have the most economic intions in the Houston area. They trained centives as we are successfully imtechnicians, many of whom had zero proving access for their members to
eye-care experience before, on how to complete the diabetic retinal exam,”
use them system. As the only things Crawford said. “As our largest payer,
needed were Internet access and a the Centers for Medicare and Medicaid
small room with dim lights, Dr. Chu Services insures the largest number
said the upfront start-up costs were of patients with diabetes.”
When a practice decides to work with
manageable.
Since purchasing the systems in the IRIS system, someone on practice
2013, more than 58,000 scans have staff, often a medical assistant or even
been performed at Harris Health, Dr. front-desk person, is given a half day
of training on how to use the system.
Chu said.
“We have developed a customized- Dr. Gupta describes the training and
care plan based on the interpretation support as high touch.
“We don’t just sell them a box,”
results performed in the IRIS Reading
he said.
Center,” she said.
Incorporating use
“Patients with susof the imaging syspected pathology are
tem along with everyreferred to optometrists
A retinal exam
thing else a primaryfor further screening,
system improves
care practice does may
and those patients with
access for patients
take some getting used
proliferative disease
with diabetes to
to at first. It takes some
can come directly to
detect eye disease
thoughtful workflow
our retina specialists
early and refers
among nurses, schedfor timely care,” Dr.
them to an eye-care
uling staff, and within
Chu said. “In a system
specialist for further
the electronic medical
where we have greater
evaluation and
record systems, Dr.
demand than resources,
treatment.
Gupta said.
we’ve been able to filter
Primary-care pracout patients who don’t
tices that follow the
have pathology to create more capacity for those who need company’s recommended best practices
do well with IRIS, Crawford said—the
timely intervention.”
The percentage of patients with ones that struggle are those that do
diabetes who are getting the initial not have buy-in.
“It’s the primary-care practices that
screenings since they have implemented
IRIS has dramatically increased, and say ‘We’ll try to this out’ that get marthe system is now starting to look at ginal improvement,” Crawford said.
“We work hard to ensure that the practheir outcomes.
Some primary-care offices are now tice is invested and have adopted a
setting up systems where the test is system-wide approach to improving
administered at their office, but a local outcomes.” ■
ophthalmologist’s office will call with
the results and set up the follow-up
eye exam, Crawford said.
The PCP also receives a copy of
the results.
37
‘We have developed a
customized-care plan based
on the interpretation results.’
— Yvonne I. Chu, MD, MBA
TAKE-HOME
BUSINESS SIDE
AND LOGISTICS
The IRIS system is now in 25 states.
There were 80,000 patients screened
with IRIS last year, said Dr. Gupta,
and that’s a number that may at least
double this year, he believes.
Insurance coverage has been favorable as this approach saves cost, improves quality outcomes, and docu-
Comfort in the
blink of an eye.
For computer users, the average blink rate
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With the average American spending up
to 8 hours per day in front of a computer,
it’s no wonder so many suffer from dry eye.
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Expand your practice with the VeraPlug™ today.
YVONNE I. CHU, MD, MBA
E: ychu@bcm.edu
Dr. Chu did not indicate any financial interest in the subject matter.
SUNIL GUPTA, MD
E: guptasunil@icloud.com
Dr. Gupta is founder and chief medical officer of Intelligent Retinal
Imaging Systems.
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38
technology
Mobile refractive screening system
yields real-world applications
Added benefit of portable diagnostics could bring autorefraction to underserved populace
By Tal Raviv, MD, FACS, Special to Ophthalmology Times
NE W YORK ::
WITH A SMALL, mobile platform, autorefractive technology (SVOne Pro, Smart Vision Labs) allows virtually anyone capable of
operating a mobile device to conduct an autorefraction, potentially opening the door to
providing refractive screening virtually anywhere in the world, or just outside office walls.
The 1-pound, hand-held, smartphone-based
autorefractor utilizes Hartman-Shack wavefront
aberrometry. This update to the first version
of the unit adds expanded measurement parameters and enhanced usability. The SVOne
Pro allows the operator to see the patient’s
eye when aligning the pupil, and once a good
Shack-Hartmann grid is present, the software
automatically records three autorefraction measurements. All of this is accomplished within 3
seconds per eye. The SVOne Pro has a spherical range of -14 to +14 D and cylindrical range
of -7 to +7 D.
The SVOne Enterprise includes all the features of the SVOne Pro, but is a patient-directed
vision testing station. In other words, patients
can autorefract themselves using onscreen and
voice prompts.
ministered refraction tests were compared with
the in-office legacy autorefractor and subjective exams. The results matched well for young
healthy eyes, with occasional outliers. Accommodation must be controlled for with all autorefractors, and the device’s open-field design
allows the patient to look in to the distance
during the test. A recently published clinical
study on the SVOne reported refractive measurements (in visually normal, young individuals) that were not significantly different from
four other subjective and objective procedures.1
R E A L-WOR LD IMPLIC AT IONS
The potential of these low-cost, portable diagnostic instruments is large, and is just the tip
of the iceberg of what is possible. There are already smartphone attachments in development
for lensometry, subjective visual acuity, and
indirect ophthalmoscopy/fundus photography.
The platform may eventually measure higherorder aberrations, and perhaps even perform
topography.
Its portability increases access and can help
bring refractive eye care to underserved populations around the globe and here in the United
CLINICAL USE
States. Domestically, future versions of this deThe device sits atop on a tripod/stand. First vice may be of value for school vision screenthe device takes a photo of the patient and ings, mobile medical services, pediatric mediasks a series of patient history questions, then cal practices, or nursing homes to name a few.
guides the patient through each
Future versions of the selfeye’s measurement, and finally
guided, vision-testing station
it displays the result—which can
could become integral to the
The advent
be printed or sent to a HIPAAburgeoning realm of telemedof portable
secured cloud account.
icine. Imagine a refractive viautorefractor
Most millennial patients eassion-screening kiosk next to the
technology may
ily performed their own refracblood pressure testing kiosk in
deliver autorefraction
tions without any assistance;
pharmacy retail locations. Sigto populations that
basically, anyone who can take
nificant refractive errors can
might not otherwise
a “selfie” can operate the unit.
be evaluated by eye-care prohave any access to
Once they completed the exam,
fessionals from any location,
eye care.
and saw their refraction, most
and follow-up service can be
patients had a “wow” response
provided or recommended as
and described the experience
needed.
as “cool.” A few older patients who were able
Theoretically, the device will become small
to operate it did so with mixed reactions and and inexpensive enough to ship to consumers
results.
who could perform their own refraction and
Exam findings generated from the self-ad- send the device back (or purchase it).
TAKE-HOME
SELF-GUIDED TEST
VIDEO Watch as a patient participates
in a vision exam through the self-guided refraction
system.Go to http://bit.ly/1T0sQrY
(Video courtesy of Tal Raviv, MD, FACS)
POSSIBILITIES LARGE,
LIMITATIONS EXIST
Subjective manifest refinement of autorefraction data is the standard of care in the United
States, as is a comprehensive eye examination
for pathology. This technology is not going
to replace autorefractors that are currently in
physician’s practices, or comprehensive exams
that all patients should undergo. In the near
term, this technology may bring autorefraction to populations who might not otherwise
have access to eye care.
Though in its infancy, this technology is
promising in that it has real-world applications, and will only get better. ■
References
1. Ciuffreda KJ, Rosenfield M. Evaluation of the SVOne:
A handheld, smartphone-based autorefractor.
Optometry and Vision Science. 2015;92:1113-1139.
TAL RAVIV, MD, FACS
P: 212/889-3550
Dr. Raviv is founder and medical director, Eye Center of New York. He
dxid not indicate a proprietary interest in the subject matter
practice management
39
For whose convenience:
The practice or the patient?
View systems from perspective of patients for areas that actually inconvenience them
Putting It In View By Dianna E. Graves, COMT, BS Ed
The 15th Annual
BOS TON ::
do a fair amount of travelOn a mission now, I began to
ing, so I have become a frewatch all of the times inconvequent customer of the local
nient “things” were done for my
transport facility that houses
convenience—the number was
my truck offsite and shuttles
astounding.
me to the airport.
About a year ago, they
STOP TO THINK ABOUT IT
started taking online reservations
It’s pouring rain, you need gas; you
to expedite the process, as well as
pump in the amount you need (which
to reserve a space for your vehiis like taking your daily SAT tests all
cle. You estimate the length of time
over again by the time you push ten butyou need to park and pre-pay the
tons regarding your zip code, whether
amount.
you want a car wash, and whether
Recently, my
you want a receipt) and
flight departure time
begin to pump.
returning to MinneAt the end, waitGiving pause to soapolis was pushed
ing for the receipt, a
called conveniences
up two hours, so my
prompt pops up that
that are offered
arrival time to the
says: “See attendant
for the sake of the
parking ramp ended
for receipt.”
patient may reveal
up being 2.5 hours
I don’t want to
just the opposite.
early.
see the attendant
As I was settling
because someone
the final bill, I nodidn’t put in new
ticed I pre-paid $62.00 but the final
paper—that’s why I did everything
bill totaled $57.00. I asked the attenat the pump. Now, I have to walk in
dant if my card would be refunded
the rain to get the receipt—for my
the difference.
convenience.
She smiled and stated: “No, we
I was in a restaurant that autodon’t do that. Your original resermatically added in a 15% tip for me
vation is what we base the total on,
so I wouldn’t have to do the math.
including a $3.00 fee for the ability
The service was marginal, food
to pre-book. Pre-booking is a conve- overcooked and over-spiced, and
nience to ensure a space!”
the wait time after ordering was riSo I smiled back and said: “So
diculous. Yet the automatic recomI’m being overcharged because the
mendation was 15%. Not this time!
airline made a change for my conI was surrounded by the frustravenience and my truck had a place
tion of people being good to me for
to be even if it was for a shorter
my convenience.
than planned trip?!”.
So you can imagine my shock
She returned my receipt, smiled,
when I had a patient call to comand said: “That’s right.”
plain that during their exam they
I want stock in that company!
had requested to have their glasses
How many people a day were
and refraction checked so they
overcharged ten cents, a quarter, or
could buy a new pair of glasses
dollars because of no refunds?
Continues on page 40 : Convenience
I
Downeast
Ophthalmology
Symposium
SEPTEMBER 23-25, 2016
Bar Harbor, Maine
TAKE-HOME
For further information, contact:
Shirley Goggin
Maine Society of Eye Physicians and Surgeons
P.O. Box 190, Manchester, ME 04351
Tel: 207-445-*%#gin@mainemed.com
www.maineeyemds.com
40
practice management
CONVENIENCE
(total would have been $895.00 profit to our
business) and the technician told them they
would do the exam as the doctor had ordered and then bring them back—wait for
it—at their convenience, for the refraction at
later date.
The patient went on a rant for 10 minutes
how she had taken a PTO day for this appointment and would need to take another day out
of her vacation time for the refraction. She
had requested the refraction two weeks ago
and no one told her she couldn't have it. She
ended that she would be going to one of the
box stores for the exam and glasses on the
weekend versus returning to us because they
truly were convenient to her.
A N D, SH E WA S R IGH T !
Another area you see this in your office is
when the doctor schedules a patient for a
routine exam, and then they request a visual field, OCT and even A-SCAN at the
same time.
Patients think they are coming for an
hour and a half and are there much longer.
Even if you prepare them for an expanded
time, they are not happy. Their work is not
happy and their kids are waiting on the curb
to be picked up! Last but not least, they ran
out of money on the parking meter or in the
parking ramp and they now want help with
the parking fee due to the inconvenience.
Yes, the inconvenience.
Guess which patient isn’t going to keep
the follow-up appointment?
What I have painfully begun to see is that
many things that are done for the customer's convenience are not done for the customer at all. They are done for your convenience and the business you are running.
Unfortunately, customer service “buzzwords” such as “for your convenience” become easy go-to answers when patients are
angrily contesting your true motives. When
a patient finally realizes it is more about
your convenience,
they will get angry
and vocal.
I challenge you to
look at your systems
and see if you have
these areas that actually inconvenience
your patients:
1. Physicians who
cancel clinics on short notice and rebook at
times, or clinic sites that the patient didn’t
choose.
2. The physician is out, or called into surgery, and the patient is seeing a physician
they don’t know. Patients have trust in their
doctor, and while their partner is willing to
see the patient so they don’t have to be rescheduled, and therefore inconvenienced,
please make sure to advise the patient of the
substitution before they get to the office. A
past personal physician’s office of mine did
that twice to me—and I now go to another
office, and a new provider.
3. Give options please!
Patient requests: “I’ve already been here
two hours, can I please reschedule for another time?” Explain that there will be another office fee, or change of location, and
let me make the decision.
The patient is thinking: “If this change
of location or even physician, is for my con-
venience, then why am I irritated? Just because the office has a plan for me, doesn’t
mean I agree with it. Please involve me
in discussions regarding me and my
treatment.”
Once you start looking for the “for your
convenience” moments examples in your office, you will soon become inundated, and
‘I challenge you to look at
your systems and see if you
have these areas that actually
inconvenience your patients.’
shocked, with what you find.
These need to be rectified and corrected
in your practice. They also need to be seen
as they really are—more of a convenience
for your group versus the patient.
So the next time I’m at the airport parking area and I hear how waiting for the
pick-up van to be totally full (sometimes 35
minutes) before we are allowed to go to the
ramp—while needing to ride around exiting customers for another 15 minutes— is
for my benefit because it keeps costs down, I
am going to give the woman a big smile and
say: “Excuse me—I disagree.” ■
DIANNA E. GRAVES, COMT, BS ED
E: dgraves@stpauleye.com
Dianna Graves is clinical services manager at St. Paul Eye Clinic PA,
in Woodbury, MN. Graves is a graduate of the School of Ophthalmic
Medical Technology, St. Paul, MN, and has been a member of its teaching faculty
since 1983.
Advertiser Index
Advertiser
Abbott Medical Optics
www.amo-inc.com
Page
CVTIP, 5
Advertiser
Haag-Streit
Page
29
Page
OCuSOFT
CV3
P: 513/658-0574
Rhein Medical
www.haag-streit-usa.com
Alcon Laboratories Inc.
Advertiser
15-16, 19-20,
23-24, 46, CV4
3
P: 800/637-4346
JCAHPO
33
www.rheinmedical.com
Lacrivera
37
Shire Ophthalmic
P: 800/862-5266
www.alcon.com
Bausch + Lomb
7
P: 415/971-4650
10-13
P: 800/227-1427
www.bausch.com
Maine Society of Eye Physicians
and Surgeons
Beaver Visitec International
31
Modernizing Medicine
www.modmed.com/ophthEMR
Doheny Eye Institute
27
Oculus Inc.
39
CV2
35
Sun Pharmaceutical Industries
17
This index is provided as an additional service.
The publisher does not assume any liability for errors
or omissions.
IN DISPENSABLE
41
( In Brief )
Consumer survey results
Getty Images/Eyecandy Images (top); Graphic courtesy of Transitions Optical (right)
TRANSITIONS SHEDS LIGHT
ON UV, BLUE LIGHT HARM
Managing
dispensary
complaints
Five simple steps to resolving customer concerns
begin by turning ‘A LEAF’
Dispensing Solutions By Arthur De Gennaro
n old adage says: “The customer is always right.”
I used to work for an optical company that leased optical shops inside J.C. Penney. Our human resources manager modified that rule to say: “The customer is not always right, but he/she is still the customer.”
As a guide for customer service, we were asked to follow the Golden Rule, which everyone knows as: “Do unto
others as you would have others do unto you.” To keep that idea top of
mind, employees wore a small golden ruler on their lapel or collar.
Continues on page 42 : Complaints
A
NE W YORK :: THOUGH EXPOSURE to ultraviolet (UV) rays and harmful blue light are both
on the minds of Americans, many do not know
these types of light share a source, according
to a Transitions Optical consumer survey, conducted by Wakefield Research.
When asked which types of light are harmful to the eyes long term, most people identify sunlight (76% agree) as well as light from
digital screens like computers or smartphones
(61% believe this).
Only 4% of respondents, however, can correctly identify all common sources of blue light
(digital devices and screens, fluorescent lights,
incandescent light bulbs, and the sun). More
specifically, less than one in five (17%) know
that the sun is a source of harmful blue light,
when it is actually the largest singular source,
emitting over 100 times the intensity of electronic devices and screens.
“Even though discussions around the dangers of harmful blue light are at the public
forefront, we are finding that many people are
misinformed about the sources of harmful blue
light,” said Patience Cook, director, North America marketing, Transitions Optical. “Eyecare
professionals should be ready to discuss this
topic of concern and recommend products that
offer blue-light-filtering benefits that appeal to
today’s modern lifestyle.”
To that end, Transitions has also developed
new educational materials (http://bit.ly/1YQqEIh)
to equip ECPs with the knowledge they need
to patients about harmful blue light. ■
42
indispensable
COMPLAINTS
Customers and customer service, however, have evolved.
Today’s consumers are far more demanding and knowledgeable. They expect
more value for their money and extremely
good service.
Consequently, contemporary retail
workers are asked to use what I call the
“new” Golden Rule: “Do unto others as
they would like you to do unto them.”
The new rule takes into consideration
that not everyone will want what you or I
might want. It is therefore imperative that
you determine what each customer views
as valuable and try to provide it. Since everyone is different there is no one formula
for success.
Here’s a process that should help to resolve dispensary complaints more effectively. Use the acronym “A LEAF” to remember the individual steps:
LISTEN
connect, the more likely it is they will see
Listening is the most important customervalue in your plan and accept it. Any plan
service tool in anyone’s armament. Learning that exceeds customers’ expectations will be
to listen with an empathetic heart will enviewed extremely positively. The reverse is
able you not only to understand what cusalso true
tomers are looking to accomplish, but also
what assurances they will need in order
FOLLOW THROUGH
to trust you to handle the problem to their
Keep in mind that customers have already
satisfaction.
experienced dissatisfaction and have lost
After asking customers what the probtrust in the dispensary. The only way to relem is, simply listen. Listen
establish that trust is to demintently. Don’t rush this proonstrate the event was an
cess. Customers need to vent.
unusual occurrence and that
Just allowing customers to
your dispensary’s service is
Having a clear
vent can often make a situabetter than that.
understanding of
tion much easier to resolve.
Consequently, whatever
expectations from
The goal is to determine what
the plan, follow through diloptical dispensary
customers are looking to acigently on every aspect of
consumers is key to
complish and what it will
it. This means engineering
being able to resolve
take to satisfy them.
processes that allow you to
complaints.
monitor the progress of your
plan on at least a daily basis.
EMPAT H Y
Communicate with customPutting yourself in another’s shoes, so to
ers promptly at those times when you said
speak, was the intent of the old Golden Rule. you would.
In that respect, it still has validity.
Customers’ concerns are not over until
Something as
customers have obtained the agreed-upon
simple as, “I unservice they were looking for and acknowlderstand how you
edge having received it. This assumes you
feel. I’m sorry you
will follow through by personally speaking
have experienced
with them and getting them to express their
(this problem). It
satisfaction.
must be very frusIf you have done a good job, they will
trating” is a good
thank you for providing such a high level
way to begin to reof service and, more importantly, for carbuild
rapport.
This
ing about them. This type of individual car— Arthur De Gennaro
technique works
ing is what often turns customers with combecause it allows
plaints into advocates for your business.
customers to feel
Wouldn’t that be a nice outcome? ■
that you are on their side.
TAKE-HOME
‘The goal is to determine
what customers are looking
to accomplish and what it will
take to satisfy them.’
A N T ICIPAT E
The first step in being a good customer
service representative is to anticipate what
customers are thinking and, more importantly, feeling.
Anticipate that returning customers may be
angry, frustrated, annoyed, stressed, inconvenienced, disappointed, disillusioned, skeptical, and a host of other negative emotions.
All of this equates to a loss of trust in
you and your practice. To turn the situation around, it will be necessary to re-establish trust.
OPHTHALMOLOGY TIMES (Print ISSN 0193-032X, Digital ISSN 2150-7333) is published
semimonthly except for one issue in Jan, May, Aug and Dec (20 issues yearly) by UBM
Medica, 131 W First Street, Duluth, MN 55802-2065. Subscription rates: $200 for one year
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Include $6.50 per order plus $2 per additional copy for U.S. postage and handling. If
ASSIST
While listening, formulate a plan of action.
This is a list of what you will propose specifically to satisfy customers or make things
right. Now is the time to share your plan
with customers. If you have listened carefully, your plan should suit their needs.
As you make your proposal, be sure to
“connect the dots” between what you are
proposing and what customers expressed
they wanted/needed. The more dots you
ARTHUR DE GENNARO is president of Arthur De Gennaro
& Associates LLC, an ophthalmic practice management firm that
specializes in optical dispensary issues. De Gennaro is the author
of the book The Dispensing Ophthalmologist. He can be reached at
803/359-7887, arthur@adegennaro.com, or through the company’s Web site, www.
adegennaro.com. He maintains a blog at www.adgablog.wordpress.com.
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after-hours
46
by Jolie Higazi
Vitreoretinal surgeon
fnds purpose in
community service
F
practicing at The Eye Associates, Sarasota, FL, and still
looks for opportunities to get
involved in service.
In 2009, Dr. Mali volunteered as a
camp counselor at Georgia LIONS Camp
for the Blind, a summer camp in Waycross, GA for 6- to 10-year-old visually
impaired campers.
At camp, Dr. Mali was responsible
for Stevie, a 9-year-old with a history of
aniridia and glaucoma. “I showed him
how to fish for the first time and he even
Joshua Mali, MD, has volunteered at multiple
caught his first fish!” he explained.
camps and mission trips to help children and
“He was so happy and to me it was
adults who are visually impaired.
so inspirational because I was able to
help him overcome his visual impairthings I cherish. I reflect on those
ment and together we succeeded with courage
fun experiences and being able to
and conviction,” he said. “This was such a rehelp all those people.”
warding experience and serves as a constant reIn November 2015, Dr. Mali
served in his own community in
minder of why I became and love
Florida with Remote Area Medibeing an ophthalmologist and
in individuals with the AcrySof® Natural
cal, an organization aimed at proretinal specialist.”
IOL and normal color vision. The effect
viding medical care to those with
Later that same year, Dr. Mali
on vision of the AcrySof® Natural IOL
in subjects with hereditary color vision
limited medical access.
served again with Camp Abilidefects and acquired color vision defects
“It touched home for me beties
at
LIONS
Camp
in
Maryland,
secondary to ocular disease (e.g.,
cause this is where I live, these
where he worked with campers
glaucoma, diabetic retinopathy, chronic
uveitis, and other retinal or optic nerve
in a sports-centered environment. are local people in the community
diseases) has not been studied. Do not
who need healthcare,” he said.
“I love sports,” he explained.
resterilize; do not store over 45° C.
Dr. Mali’s continued service
“So
it
was
cool
to
be
able
to
help
ATTENTION: Reference the Directions
for Use for Model AU00T0 for a complete
work is a constant reminder of
campers who are visually imlisting of indications, warnings and
why he got into ophthalmology.
paired play sports and have some
precautions.
“[It provides] a sense of purgood old camp fun. They don’t
pose and a sense of peace,” Dr.
let [being visually impaired] stop
Mali said.
them. I am definitely trying to
Dr. Mali anticipates participatmake an effort to continue that
ing in more projects and incorpothroughout my career. That’s the
rating them into family trips with
reason I got into this, and I don’t
his wife, who is completing her
want to forget it.”
residency in ophthalmology, and
During a Medical Ministry Intheir future children.
ternational Project in 2012, he
“Whether it’s family, religion,
served as a volunteer ophthalmic
service work—whatever brings
surgeon in Tulipan, Mexico, where
you peace and a sense of purpose
he performed cataract surgery for
in your life, make sure to make
the indigenous population.
time for it,” he said. “We work a
One of his favorite memories
from the trip was walking around lot, but always in life it’s about
prioritizing and making time for
the village and joining a soccer
those things that are important
game with the local children.
to you. For me, it’s been easy to
“We kind of just jumped in
merge those things and make it a
and played with them spontane© 2015 Novartis 1/15 US-ULS-15-E-0442-A
hybrid.” ■
ously,” he said. “Those are the
CAUTION: Federal (USA) law restricts this
device to the sale by or on the order of a
physician.
INDICATIONS: The AcrySof® IQ aspheric
intraocular lens (“AcrySof IQ”) is intended
for the replacement of the human lens
to achieve visual correction of aphakia in
adult patients following cataract surgery.
This lens is intended for placement in the
capsular bag.
WARNING/PRECAUTION: Use the
UltraSert™ Pre-loaded Delivery System
(“UltraSert”) at temperatures between
18° C (64° F) and 23°C (73° F). Use only
Alcon viscoelastic qualified for this device.
Do not use the UltraSert if the nozzle
appears damaged or deformed. Follow
the Directions for Use for correct order and
sequence of steps to avoid damage to the
IOL or the UltraSert.
Careful preoperative evaluation and sound
clinical judgment should be used by the
surgeon to decide the risk/benefit ratio
before implanting a lens in a patient with
any of the conditions described in the
Directions for Use. Caution should be used
prior to lens encapsulation to avoid lens
decentrations or dislocations.
Studies have shown that color vision
discrimination is not adversely affected
magenta
cyan
yellow
black
Photos courtesy of Joshua Mali, MD
or Joshua Mali, MD, the road
to becoming an ophthalmologist started when he was just
a teenager. When Dr. Mali was
about 14 years old, his family took
a trip to Nicaragua with Health for
Humanity, a Baha’i-inspired volunteer
organization that provides medical services to
those in poverty. He remembered how inspired
he felt that even at such a young age, he could
help others by volunteering. This was the beginning of what would be a decades-long service-oriented passion for Dr. Mali.
“Doing service work kind of inspired me,”
he said. Having the opportunity to spend time
with his family at the same time as providing
service to these people who really needed it was
a merger of the things he most enjoyed in life.
“I really liked that feeling,” he said.
Today, Dr. Mali is a vitreoretinal surgeon
ES773709_OT050116_046.pgs 04.26.2016 03:02
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Human Factor Testing, February, 2015. 2. AcrySof® IQ Aspheric IOL with the UltraSert™ Pre-loaded Delivery System Directions for Use. 3. Comparative Assessment of IOL Delivery Systems. Alcon internal technical report:
TDOC-0018957. Effective Date 19 May 2015.
CME MONOGRAPH
Instant CME Certificate Available With
Online Testing and Course Evaluation
at http://bit.ly/pressure16
EYE
Proceedings From a
CME Symposium Held
During AAO 2015
ORIGINAL RELEASE DATE: MAY 1, 2016
MOST RECENT REVIEW DATE: APRIL 15, 2016
EXPIRATION DATE: MAY 1, 2017
FACULTY
Robert N. Weinreb, MD (Chair)
This continuing medical education activity is jointly provided by
The University of Louisville Office of Continuing Medical Education
and MedEdicus LLC.
Robert M. Feldman, MD
Neeru Gupta, MD, PhD, MBA
Tony Realini, MD, MPH
Rohit Varma, MD, MPH
This continuing medical education activity is supported through an
unrestricted educational grant from Bausch & Lomb Incorporated.
Distributed with
CHAIR
Robert N. Weinreb, MD
Chairman and Distinguished
Professor of Ophthalmology
Director, Shiley Eye Institute
Director, Hamilton Glaucoma Center
University of California, San Diego
San Diego, California
FACULTY
Robert M. Feldman, MD
Clinical Professor and Chair, Department
of Ophthalmology & Visual Science
Richard S. Ruiz Distinguished
University Chair
Robert Cizik Eye Clinic
University of Texas Health Science Center
at Houston
UTHealth Medical School
Houston, Texas
Neeru Gupta, MD, PhD, MBA
Professor and Dorothy Pitts Chair
Ophthalmology & Vision Sciences
Laboratory Medicine & Pathobiology
Chief of Glaucoma
University of Toronto
Toronto, Canada
Tony Realini, MD, MPH
Associate Professor of Ophthalmology
West Virginia University Eye Institute
Morgantown, West Virginia
Rohit Varma, MD, MPH
Grace and Emery Beardsley Professor
and Chair
Department of Ophthalmology
University of Southern California (USC)
Director, USC Eye Institute
Associate Dean for Strategic Planning and
Network Development
Keck School of Medicine of USC
Los Angeles, California
Purpose and Target Audience
The armamentarium of intraocular pressure (IOP)lowering pharmacologic and surgical treatments
for glaucoma continues to grow. Nonetheless,
patients with glaucoma are still at risk for vision
loss and blindness due to their disease.
Unfortunately, treatments to protect retinal
ganglion cells from degeneration — the ultimate
cause of vision loss — are lacking. New drugs, new
fixed combinations of existing drugs, and new
procedures constantly challenge the traditional
treatment paradigm and are showing promise in
lowering IOP and slowing disease progression by
multiple mechanisms of action. Ophthalmologists
who treat glaucoma must stay abreast of new
treatments and understand their role in the
context of the pathophysiology and cell biology of
glaucoma to optimize patient outcomes. The
purpose of this activity is to review recent
advances in the understanding of the
pathophysiology and treatment of glaucoma that
are challenging traditional treatment paradigms.
This educational activity is intended for
ophthalmologists.
Learning Objectives
Upon completing this educational activity,
participants should be able to:
• Discuss the etiology of glaucoma
• Select and document IOP-lowering treatment
plans for patients with glaucoma based on
efficacy, safety, guidelines, and patient
preferences
• Describe the potential role of emerging
therapeutics in the management of glaucoma
Joint Provider Statement
This activity has been planned
and implemented in accordance
with the Essential Areas and
Policies of the Accreditation
Council for Continuing Medical Education (ACCME)
through the joint providership of the University of
Louisville and MedEdicus LLC. The University of
Louisville is accredited by the ACCME to provide
continuing education for physicians.
AMA Credit Designation Statement
The University of Louisville Office of Continuing
Medical Education designates this enduring
material for a maximum of 1.0 AMA PRA Category
1 Credit™. Physicians should claim only the credit
commensurate with the extent of their
participation in the activity.
Grantor Statement
This continuing medical education activity is
supported through an unrestricted educational
grant from Bausch & Lomb Incorporated.
Joern B. Soltau, MD
Disclosure of Unlabeled Use
This educational activity might contain discussion
of evidence-based and/or investigational uses of
agents that are not indicated by the FDA. For
additional information about approved uses,
including approved indications, contraindications,
and warnings, please refer to the official
prescribing information for each product for
discussion of approved indications,
contraindications, and warnings.
Associate Professor
Director, Glaucoma Service
Director, Ophthalmology Residency
Training Program
University of Louisville School of Medicine
Louisville, Kentucky
Instructions & Registration
This course takes approximately 1.0 hour. Please
read the monograph, consult any additional
references if needed. Once the materials have been
reviewed, you will go to http://XXX to take a post
test followed by course evaluations, after which you
will be able to generate your CME certificate.
Reviewed by:
2
Hardware & Software Requirements
• High speed Internet connection
(Broadband, Cable or DSL)
• Windows 2000 or higher
• 256 MBs or more of RAM
• Internet Explorer 6.0 or higher
• Windows Media Player 10.0 or higher
• Adobe Acrobat 7.0 or higher
• Course content compatible with Mac OS
Disclaimer
The views and opinions expressed in this
educational activity are those of the faculty and
do not necessarily represent the views of the
University of Louisville, MedEdicus LLC, or
Bausch & Lomb Incorporated.
Disclosures
As a provider accredited by the ACCME, the Office
of CME & PD, School of Medicine, University of
Louisville, must ensure balance, independence,
objectivity, and scientific rigor in all its sponsored
educational activities. All planners, faculty,
reviewers, and other persons that affected the
content of this CME activity were required to
submit a financial disclosure form from which
relevant conflicts of interest were determined.
The persons below disclosed the following:
CME Reviewer: Dr Joern B. Soltau: No relevant
financial relationships with any commercial
interests.
Faculty: Dr Robert M. Feldman: Alcon (Consultant);
InnFocus Inc; XOMA (Contracted Research).
Dr Neeru Gupta: Bausch & Lomb Incorporated
(Consultant).
Dr Tony Realini: Alcon; Alimera Sciences; Bausch
& Lomb Incorporated; Inotek Pharmaceuticals
Corporation; Reichert, Inc (Consultant); Alcon
(Contracted Research); Lumenis (Speaker’s Bureau).
Dr Rohit Varma: Bausch & Lomb Incorporated
(Consultant).
Dr Robert N. Weinreb: Alcon; Allergan; Bausch &
Lomb Incorporated; Valeant (Consultant); Aerie
Pharmaceuticals, Inc; Genentech, Inc; Quark
(Contracted Research).
MedEdicus: Cynthia Tornallyay, RD, MBA, CHCP;
Diane McArdle, PhD; and Michelle Ong have no
relevant financial relationships with any
commercial interests.
University of Louisville CME & PD: The CME & PD
staff and Advisory Board have nothing to disclose.
Medium or Combination of Media Used: Online
Enduring Material Activity
Method of Physician Participation: Printed and
Online/Digital Monograph
Estimated Time to Complete the Educational
Activity: 1.0 hour
Provider Contact Information
For questions about the CME activity content,
please contact University of Louisville at
cmepd@louisville.edu.
Privacy Policy
All information provided by course participants is
confidential and will not be shared with any other
parties for any reason without permission.
Copyright
©2016 MedEdicus LLC.
INTRODUCTION
EYE
Primary open-angle glaucoma (POAG) is a leading cause of vision loss in the
United States and the world, and represents one of the most common
ocular conditions for which patients visit their eye care provider. Although
the tools used to treat glaucoma have evolved over time, the approach to
glaucoma management, that is, reduction of intraocular pressure (IOP), has
remained constant for more than 150 years. In this review, our expert
faculty will review new information on glaucoma pathophysiology, including
the role of ocular perfusion pressure (OPP) and cerebrospinal fluid (CSF)
pressure in the development of glaucomatous optic neuropathy. In addition,
promising treatments in the clinical trial pipeline will be reviewed. Finally,
a case discussion will highlight the process by which the selection of
glaucoma therapies can be tailored to treat individual patients.
—Robert N. Weinreb, MD, for the faculty
PATHOPHYSIOLOGY OF GLAUCOMA
—Robert N. Weinreb, MD
Primary open-angle glaucoma presents numerous challenges in
terms of both diagnosis and management. In the absence of a
definitive test for the disease, the diagnosis of glaucoma remains
a clinical impression based on the synthesis of physical findings
and both structural and functional testing. A fairly nebulous
definition of POAG, the language of which underscores the
imprecision of the diagnostic features of the disease, further
complicates the process. According to the American Academy
of Ophthalmology:
Primary open-angle glaucoma (POAG) is a chronic, progressive
optic neuropathy in adults in which there is a characteristic
acquired atrophy of the optic nerve and loss of retinal ganglion
cells and their axons. This condition is associated with an open
anterior chamber angle by gonioscopy.
At the most basic level, POAG is an optic neuropathy; however,
definitive causal factors have remained elusive. The role of
elevated IOP in glaucoma, once thought to be the primary cause of
POAG, has become more complex over time. Epidemiologic and
longitudinal studies have demonstrated that elevated IOP is neither
necessary nor sufficient to explain the development of POAG.2
Instead, IOP is considered a risk factor for both the development
and progression of glaucoma. Interventional clinical trials support
this relationship; the reduction of IOP reduces the risk of
developing glaucoma and its progression across the full range of
IOPs.3-5 In these studies and others, however, one consistent
observation remains clear: some eyes with glaucoma continue to
progress despite significant IOP reduction. One explanation may be
that these eyes required even greater IOP reductions to achieve
disease stability. Another explanation is that other factors beyond
IOP also play a role in the pathophysiology of glaucoma.
Pathophysiologic Mechanisms
Many candidate contributors to glaucoma pathogenesis have been
postulated (Figure 1).6 These all share 1 key feature: they have the
potential to damage retinal ganglion cells (RGCs). The health of
both the RGCs and the cells of the lateral geniculate nucleus
depends on anterograde and retrograde axoplasmic flow to deliver
crucial nutrients and prosurvival factors. Intraocular pressure is
believed to lead to RGC loss by deforming the lamina cribrosa in
the optic nerve head and blocking axoplasmic flow.
Microcirculation
Intraocular
pressure
Lateral geniculate
nucleus and
other target
Ischaemia—hypoxia
Retinal
ganglion
cell
Lamina cribrosa
Aberrant
immunity
Inflammatory
cytokines
Blockade of
neurotrophins and other
target derived factors
Astrocytes
Excessive glutamate
stimulation
Glial cells
Figure 1. Key contributors to POAG pathophysiology6
Reprinted from The Lancet, 363, Weinreb RN, Khaw PT, Primary open-angle
glaucoma, 1711-1720, Copyright 2004, with permission from Elsevier.
The optic nerve head’s microcirculation may also be impaired
in some eyes, leading to hypoxia and ischemia. Clinical evidence
in support of this theory includes the frequent observation of
disc hemorrhages in eyes with glaucoma as well as the common
finding of migraine and vasospastic comorbidities, such as
Raynaud phenomenon, in patients with glaucoma, which may
be related to progression in these patients.7 Other putative
factors include circulating autoantibodies to RGCs and
proinflammatory cytokines that may also contribute to
RGC death.6
3
Established Risk Factors for Glaucoma
Clinically, many risk factors for the development of POAG have
been identified in clinical trials. These include elevated IOP,
increasing age, thin central corneas, as well as both optic nerve and
visual field parameters.8 Other risk factors exist as well. Corneal
hysteresis is a biomechanical property that reflects the viscoelastic
nature of the cornea, that is, how easily it can be deformed and
how easily it returns to its normal configuration after deformation.
Like corneal thickness, corneal hysteresis may alter the accuracy of
applanation tonometry. However, corneal hysteresis is a significant
risk factor for glaucoma independent of corneal thickness,
suggesting that it may provide additional information on glaucoma
risk, such as a possible measure of the eye’s biomechanical
susceptibility to glaucomatous optic nerve damage.9
Additionally, family history remains a relevant risk factor for
glaucoma. First-degree relatives of patients with glaucoma have
higher than expected rates of glaucoma,10 although identification of
genes that explain more than a tiny proportion of glaucoma cases
remains elusive. It is likely that the genetics of glaucoma is a highly
complex relationship involving epigenetics mechanisms, such as
gene-gene or gene-environment interactions, among others.11
Emerging Risk Factors
Cerebrospinal fluid pressure. The optic nerve head is the site
of injury in glaucoma, and within the optic nerve head, the lamina
cribrosa, in particular, is relevant. The lamina cribrosa provides
structural support for the nerve head, and the axons of the RGCs
pass through the lamina en route to their synaptic junction in the
lateral geniculate nucleus. The lamina cribrosa separates the
spaces under the influence of IOP anteriorly and intracranial
pressure posteriorly. Any force that alters the anatomic
configuration of the lamina can threaten the health of RGC axons.
On the anterior side of the lamina cribrosa is IOP, which, when
elevated, can cause backbowing of the lamina cribrosa. This
deformation of the lamina may create shearing forces that can
impinge on the axons and interrupt axoplasmic flow, to the
detriment of RGC health.
On the posterior side of the lamina cribrosa is intracranial
pressure. The space within the optic nerve that lies between
the nerve tissue and the dura mater is filled with CSF and is
contiguous with the intracranial space. Like aqueous humor, CSF is
not stagnant but is continually produced by the choroid plexi of the
lateral ventricles; bathes the brain, spinal cord, and cranial nerves
(including the optic nerve); and is absorbed by the cranial and
spinal arachnoid villi. Also, like aqueous humor, the CSF is under
constant positive pressure, CSF pressure, which is determined by
the balance between CSF production and resorption.
Because both aqueous humor and CSF generate positive
pressures, under homeostasis, a laminar configuration that
reflects the balance between these 2 opposing forces exists. But
because the relative magnitudes of IOP and CSF pressure vary,
laminar deformation can occur.
The role of CSF pressure in the pathophysiology of glaucoma has
received significant attention. In 2008, a retrospective study from
the Mayo Clinic was the first to demonstrate a statistically
significant difference in mean CSF pressure among subjects with
and without primary POAG.12 In this study, the medical records of
patients referred to the Mayo Clinic for lumbar puncture for a
variety of indications were reviewed. The CSF opening pressure of
28 patients with POAG and 49 nonglaucomatous control subjects
was recorded. The mean opening pressure of the POAG group was
significantly lower than that of the control group (9.2 ± 2.9 mm Hg
vs 13.0 ± 4.2 mm Hg; P < .00005). Subsequently, a prospective
study conducted in China confirmed this finding, in which the
4
mean CSF opening pressure of subjects with normal-tension
glaucoma, those with high-tension POAG, and healthy subjects
was 9.5 ± 2.2 mm Hg, 11.7 ± 2.7 mm Hg, and 12.9 ± 1.9 mm Hg,
respectively.13 The CSF pressure of the normal-tension group was
significantly lower than that of the other 2 groups (P < .001).
The relationship of CSF pressure measured by lumbar puncture
in these studies with intracranial pressure is unclear. The
observation that CSF pressure is low in eyes with glaucoma
might help explain some paradoxes surrounding the relationship
between glaucoma and IOP. For instance, why do some eyes with
high IOP never develop glaucoma, whereas many eyes with
normal IOP develop glaucoma? These 2 studies demonstrate that
CSF pressure is lower in eyes with normal-tension glaucoma,
suggesting that even low IOP is adequate to deform the lamina
in the presence of low CSF pressure on the posterior side of the
lamina. Further evidence for this hypothesis comes from a recent
case report, in which a patient with normal-tension glaucoma
demonstrated sudden progression upon undergoing
ventriculoperitoneal shunting to lower CSF pressure in the
setting of normal-pressure hydrocephalus.14
Conversely, perhaps some individuals with elevated IOP also have
elevated CSF pressure, which might neutralize the pressure
gradient across the lamina cribrosa and prevent deformation of
axons. A third study, in which 17 patients with ocular hypertension
and 71 nonglaucomatous control subjects underwent lumbar
puncture, with measurement of CSF opening pressure, supports
this hypothesis. The mean opening pressure in the ocular
hypertensive group was significantly higher than that of the
control group (16.0 ± 2.5 mm Hg vs 12.9 ± 1.9 mm Hg; P < .001).15
These studies and observations suggest that the relative
magnitudes of IOP and CSF pressure, also called the translaminar
pressure difference, may be important when considering the
relationship between IOP and glaucoma. Additional research is
necessary to add strength to this intriguing hypothesis. Further
elucidation of the role of CSF pressure in IOP and glaucoma could
lead to a novel therapeutic strategy for glaucoma, given that CSF
pressure is modifiable. However, the invasive nature of current
methods for CSF pressure assessment and modification might
limit such a strategy.
Ocular perfusion pressure. In simplest terms, OPP can be
thought of as the arithmetic difference between blood pressure and
IOP. In more specific terms, OPP represents the relative intraluminal
blood pressure within the ocular circulation. Table 1 gives the
formulas for calculating mean, systolic, and diastolic OPP.16
Table 1. Formal Definitions of OPP: Mean, Systolic, and
Diastolic16
Mean OPP
2/3 [diastolic BP + 1/3 (systolic BP – diasylic BP)] – IOP
Systolic OPP
Systolic BP – IOP
Diastolic OPP
Diastolic BP – IOP
When OPP is high, ocular tissues are well perfused, and when
OPP is low, ocular tissues are less well perfused. Just as the
interplay between CSF pressure and glaucoma may represent a
pathophysiologic theoretical basis for mechanical glaucomatous
optic nerve damage, variations in OPP may provide a basis for the
ischemic theory of glaucoma damage.
Numerous epidemiologic studies have demonstrated that low
OPP and, more specifically, low diastolic OPP, increases the risk
for developing glaucoma 2- to 6-fold (Table 2).17-22
Like CSF pressure, OPP is modifiable, and OPP assessment is less
invasive. Spot estimates of OPP can be easily obtained in the
assessment is a synthesis of
all known and suspected risk
Odds Ratio
factors for the development
Study
Design
Participants
(95% Confidence Interval)
and/or progression of
glaucoma. Validated calculators
Non-Hispanic Whites and
17
Baltimore Eye Survey
Cross-sectional
6.22 (2.15-17.94)*
African Americans
exist to aid in the synthesis of
data and provide quantitative
18
†
Egna-Neumarkt Study
Cross-sectional
Non-Hispanic Whites
0.39 (0.22-0.69)
estimates of the risk of
developing glaucoma or its
Proyecto VER19
Cross-sectional
Hispanics
0.96 (0.94-0.99)*
progression. These instruments
Los Angeles Latino Eye Study20
Cross-sectional
Hispanics
1.9 (1.1-3.0)*
are limited by our lack of
knowledge of risk factors,
Barbados Eye Study21,22
Longitudinal
Afro-Caribbeans
3.2 (1.6-6.6)*‡
which are gleaned primarily
* Glaucoma risk from low diastolic OPP vs normal diastolic OPP.
from relatively small studies
†
Glaucoma risk from high diastolic OPP vs low diastolic OPP.
compared with those of other
‡
At 4 years.
disease states. Also, they do not incorporate all known risk
factors, each of which must be considered separately and in
addition to the calculator’s estimates of risk. Importantly, risk
office by measuring both IOP and blood pressure and applying
profiles change over time, so risk assessment should be
the formulas from Figure 1. A more comprehensive assessment
considered an ongoing process rather than a one-time event.
of OPP, however, can be made by assessing both blood pressure
and IOP over a 24-hour period.
Risk calculators for the development of POAG in eyes with ocular
hypertension have been developed.29,30 One of these, developed from
The 24-hour assessment of blood pressure can be easily
data collected in both the Ocular Hypertension Treatment Study and
accomplished using continuous ambulatory blood pressure
the European Glaucoma Prevention Study,29 can be accessed, at no
monitoring. This may be best accomplished in coordination with
cost, at http://ohts.wustl.edu/risk/calculator.html. After entering a
the patient’s primary care provider. The assessment is generally
small amount of patient-specific data, the calculator determines the
well tolerated and provides data from both daytime and critical
patient’s 5-year risk of developing POAG. This risk estimate can be
nighttime periods.
useful in determining the value of prophylactic therapy.
Likewise, the Triggerfish contact lens–based continuous IOP
monitor (Sensimed AG, Lausanne, Switzerland), which was
THERAPEUTIC OPTIONS FOR IOP
recently approved for use in the United States,23 can be used
to estimate IOP throughout the 24-hour period. This minimally
REDUCTION: TODAY AND TOMORROW
invasive system consists of a contact lens sensor with an
–Robert M. Feldman, MD
embedded strain gauge. It does not directly measure IOP. Rather,
it detects changes in corneal curvature that result from changes
Glaucoma therapy has 3 major goals. First, we must apply
in IOP and uses these measurements as a surrogate for IOP. An
adequate therapy to achieve our target IOP. Second, we should
antenna positioned around the orbital rim receives telemetric
prevent, or at least slow, the progression of glaucoma to prevent
data from the sensor. Data are transmitted to a portable storage
blindness. Third, and often overlooked, we should strive to
device. The system makes 300 measurements over 30 seconds,
optimize the quality of life for our patients with glaucoma with
every 5 minutes, for a full 24-hour cycle. The device is well
every clinical decision, considering the effect of both the disease
tolerated by most patients,24,25 and the output provides a
and our treatment choices on quality of life.
validated qualitative representation of IOP curve shape over
time and in response to IOP-lowering interventions.26,27
Selecting Initial Therapy
Table 2. Summary of Key Epidemiologic Studies Linking Glaucoma and OPP
The combined data from 24-hour assessment of both blood
pressure and IOP can present challenges for interpretation. An
automated way to combine the digital output of these devices for
a continuous calculation of OPP does not currently exist. One key
period worthy of close attention is the nocturnal period. At night,
in the supine position, IOP tends to be highest and blood
pressure often drops compared with daytime measurements,
thus producing nadir OPP in this period for many patients.28
Once identified, low nocturnal OPP can be addressed in several
ways and should be approached in consultation with the
patient’s primary care provider. Some patients may be
overmedicated for systemic hypertension and can discontinue
1 or more antihypertensive medications. In other patients,
changing nighttime dosing to morning dosing may help prevent
nocturnal dips. When these options are either not available or not
effective, nighttime salt loading in some patients may have value;
patients can often achieve this by simply consuming a salty
snack, such as a small bag of potato chips, before bedtime.
Global Risk Assessment in Glaucoma
When facing the decision to treat or not to treat a glaucoma
suspect, or to treat more aggressively in established glaucoma, a
global risk assessment can inform decision making. A global risk
The selection of initial therapy should be tailored to the needs of
individual patients. Considerations should include the magnitude
of IOP reduction needed, comorbidities that might make some
therapies contraindications, lifestyle issues that might make
some therapies undesirable, and any physical or cognitive
impairment that might affect the ability to reliably self-dose.
For most patients, prostaglandin analogues are the optimal first-line
therapy. These drugs are highly effective, exceedingly safe, well
tolerated, conveniently dosed once daily, and, with the availability of
generic latanoprost, also affordable. Several recent studies suggest
that selective laser trabeculoplasty is a reasonable alternative to
medications for first-line therapy.31,32 Primary surgical intervention is
typically reserved for patients with extremely high IOP, those with
end-stage disease, monocular patients at high risk for blindness,
and those with difficult-to-manage secondary glaucoma.
Emerging Glaucoma Therapeutics
In large part, the unparalleled efficacy and safety of prostaglandins
have set the bar high for future drug development. A novel
glaucoma drug has not been introduced to the marketplace since
the launch of latanoprost in the 1990s. This may soon change.
Several new molecules are in late-stage clinical development and
may reach the US marketplace in the near future.
5
Latanoprostene bunod. This modification of the latanoprost
molecule adds a nitric oxide (NO)-donating moiety to the
compound. The result is a dual-action therapeutic, in which the
latanoprost component increases aqueous outflow through the
uveoscleral pathway and the NO component activates the cyclic
guanosine monophosphate pathway, leading to trabecular
relaxation and increased conventional outflow.33 In a phase 2 study,
latanoprostene bunod provided an approximately 1 to 1.5 mm Hg
greater IOP reduction than did latanoprost (P ≤ .009).34
A phase 3 evaluation revealed that, compared with timolol, 0.5%,
dosed twice daily, once-daily dosing of latanoprostene bunod,
0.024%, produced a lower mean IOP at each of the 9 time points:
8 AM, 12 PM, and 4 PM at weeks 2, 6, and 12.35 Further, more
patients treated with latanoprostene bunod than with timolol
achieved IOP ≤ 18 mm Hg and IOP reduction ≥ 25%, with
comparable adverse events between the 2 groups.
Rho kinase inhibitors. Like latanoprostene bunod, the Rho
kinase inhibitor netarsudil mesylate (AR-13324) has multiple
mechanisms of action. The molecule inhibits the enzyme Rho
kinase and also inhibits the norepinephrine transporter, which
increases adrenergic activity. The net effect is a reduction of IOP
via increased trabecular outflow and reduced episcleral venous
pressure, which are both mediated by Rho kinase inhibition, and
reduced aqueous production mediated by norepinephrine
transporter inhibition.36,37 Two phase 3 trials have been
completed but not yet published. Future development for this
drug includes a fixed combination with latanoprost.
Advances in drug delivery. One important limitation shared
by all topical glaucoma medications is the need for daily
administration by the patient. Adherence with glaucoma medications
has been shown in numerous studies to be consistently poor.38
Several products under development seek to reduce the frequency
of dosing by using sustained-release technology. Among these is a
sustained-release formulation of bimatoprost, which is packaged in a
biodegradable implant injected into the anterior chamber in the clinic
setting and expected to provide IOP reduction for 4 to 6 months.39
A phase 3 trial vs timolol is under way.40 Both a punctal plug delivery
system41 and an intraocular implant for travoprost42 and
bimatoprost43 are also in development. Other novel delivery systems,
including the use of nanoparticles, are also being developed.44
CASE STUDY
–Neeru Gupta, MD, PhD, MBA
This patient was a 48-year-old woman with a complex medical
history that included fibromyalgia, depression, headache, and
sleep disorder. Her medications included fluoxetine and
amitriptyline. She had a sulfonamide allergy. Her father had
glaucoma. On examination, her visual acuity was 20/30 in the
right eye and 20/25 in the left eye. Anterior segments and angles
were unremarkable. Her IOP was 14 mm Hg in both eyes, with a
corneal thickness of 545 μm in both eyes. Figure 2 shows her
optic nerves, and Figure 3 shows her visual fields.
Her target IOP was set at 10 mm Hg, and she was started on a
prostaglandin analogue, but did not tolerate it.
Dr Weinreb: Dr Feldman, is there any other history or evaluation
that might be relevant?
Dr Feldman: Given the advanced stage of disease with such a
low untreated IOP, a diurnal IOP curve might be useful.
Dr Gupta: We considered that as well. Her diurnal IOP range was
8 to 14 mm Hg on no treatment.
Dr Feldman: In that pressure range, I start thinking beyond IOP. Does
she have any vascular risk factors? What is her blood pressure?
6
A
B
Figure 2. Right (A) and left (B) optic nerves of the patient. Note the loss
of inferior rim in the right eye.
Images courtesy of Neeru Gupta, MD, PhD, MBA
A
B
Figure 3. Visual fields from the patient. Note the superior visual field
loss in the right eye (A).
Images courtesy of Neeru Gupta, MD, PhD, MBA
Dr Gupta: When we asked, she reported cold fingers and
Raynaud phenomenon. We measured her blood pressure in the
clinic at 108/70 mm Hg.
Dr Weinreb: Dr Varma, you have studied the relationship between
OPP and glaucoma in the Los Angeles Latino Eye Study. What is
the significance of this low blood pressure reading in this patient?
Dr Varma: In our study and others, as you pointed out earlier, low
diastolic perfusion pressure is a strong risk factor for developing
glaucoma. It is also a strong predictor of glaucoma progression.
In patients with hypertension, we have the opportunity to reduce
systemic antihypertensive therapy or shift dosing from nighttime
to morning to prevent nocturnal dips in blood pressure. But in
this patient, the hypotension is intrinsic and not iatrogenic.
That is more difficult to address.
Dr Gupta: This patient was sent for 24-hour blood pressure
monitoring and found to have nocturnal hypotension. In an effort
to address low diastolic perfusion pressure at night, salty bedtime
snacks, such as pretzels, olives, tomato juice, or nuts, were
suggested. She does this each night before bed, and, fortunately,
she has remained stable, with no further progression.
SUMMARY
Glaucoma is a complex and incompletely understood
multifactorial disease, with many known and likely many
unknown risk factors. New risk factors are emerging and may
shed light on the pathogenesis of glaucoma. Reduction of IOP
remains the only established treatment, but novel therapeutic
targets may be on the horizon. A wider selection of available
and emerging therapies may give clinicians more options to
individualize glaucoma therapy on the basis of each patient’s
unique needs and desires. Sustained-release drug delivery
options may improve the patient experience by reducing the
need for daily dosing. The role of sustained-release formulations
of products available as topical medications in routine clinical
practice remains to be clarified, and insurance coverage issues
will also likely play a role in the clinical utility of these products.
REFERENCES
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American Academy of Ophthalmology; 2015.
2. Bahrami H. Causal inference in primary open angle glaucoma: specific
discussion on intraocular pressure. Ophthalmic Epidemiol. 2006;13(4):
283-289.
3. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension
Treatment Study: a randomized trial determines that topical ocular
hypotensive medication delays or prevents the onset of primary openangle glaucoma. Arch Ophthalmol. 2002;120(6):701-713.
4. Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early
Manifest Glaucoma Trial Group. Reduction of intraocular pressure and
glaucoma progression: results from the Early Manifest Glaucoma Trial.
Arch Ophthalmol. 2002;120(10):1268-1279.
5. Collaborative Normal-Tension Glaucoma Study Group. Comparison of
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6. Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004;
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7. Drance S, Anderson DR, Schulzer M; Collaborative Normal-Tension
Glaucoma Study Group. Risk factors for progression of visual field
abnormalities in normal-tension glaucoma. Am J Ophthalmol.
2001;131(6):699-708.
8. Gordon MO, Beiser JA, Brandt JD, et al. The Ocular Hypertension
Treatment Study: baseline factors that predict the onset of primary openangle glaucoma. Arch Ophthalmol. 2002;120(6):714-720.
9. Medeiros FA, Meira-Freitas D, Lisboa R, Kuang TM, Zangwill LM, Weinreb RN.
Corneal hysteresis as a risk factor for glaucoma progression: a
prospective longitudinal study. Ophthalmology. 2013;120(8):1533-1540.
10. Sung VC, Koppens JM, Vernon SA, et al. Longitudinal glaucoma screening
for siblings of patients with primary open angle glaucoma: the
Nottingham Family Glaucoma Screening Study. Br J Ophthalmol.
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11. Doucette LP, Rasnitsyn A, Seifi M, Walter MA. The interactions of genes,
age, and environment in glaucoma pathogenesis. Surv Ophthalmol. 2015;
60(4):310-326.
12. Berdahl JP, Allingham RR, Johnson DH. Cerebrospinal fluid pressure is
decreased in primary open-angle glaucoma. Ophthalmology. 2008;
115(5):763-768.
13. Ren R, Jonas JB, Tian G, et al. Cerebrospinal fluid pressure in glaucoma:
a prospective study. Ophthalmology. 2010;117(2):259-266.
14. Chen BH, Drucker MD, Louis KM, Richards DW. Progression of normaltension glaucoma after ventriculoperitoneal shunt to decrease
cerebrospinal fluid pressure. J Glaucoma. 2016;25(1):e50-e52.
15. Ren R, Zhang X, Wang N, Li B, Tian G, Jonas JB. Cerebrospinal fluid
pressure in ocular hypertension. Acta Ophthalmol. 2011;89(2):e142-e148.
16. Costa VP, Harris A, Anderson D, et al. Ocular perfusion pressure in
glaucoma. Acta Ophthalmol. 2014;92(4):e252-e266.
17. Tielsch JM, Katz J, Sommer A, Quigley HA, Javitt JC. Hypertension,
perfusion pressure, and primary open-angle glaucoma. A populationbased assessment. Arch Ophthalmol. 1995;113(2):216-221.
18. Bonomi L, Marchini G, Marraffa M, Bernardi P, Morbio R, Varotto A.
Vascular risk factors for primary open angle glaucoma: the EgnaNeumarkt Study. Ophthalmology. 2000;107(7):1287-1293.
19. Quigley HA, West SK, Rodriguez J, Munoz B, Klein R, Snyder R. The
prevalence of glaucoma in a population-based study of Hispanic subjects:
Proyecto VER. Arch Ophthalmol. 2001;119(12):1819-1826.
20. Memarzadeh F, Ying-Lai M, Chung J, Azen SP, Varma R; Los Angeles Latino
Eye Study Group. Blood pressure, perfusion pressure, and open-angle
glaucoma: the Los Angeles Latino Eye Study. Invest Ophthalmol Vis Sci.
2010;51(6):2872-2877.
21. Leske MC, Wu SY, Nemesure B, Hennis A. Incident open-angle glaucoma
and blood pressure. Arch Ophthalmol. 2002;120(7):954-959.
22. Leske MC, Wu SY, Hennis A, Honkanen R, Nemesure B; BESs Study Group.
Risk factors for incident open-angle glaucoma: the Barbados Eye Studies.
Ophthalmology. 2008;115(1):85-93.
23. FDA permits marketing of device that senses optimal time to check
patient’s eye pressure. U.S. Food and Drug Administration Web site.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm489308.htm. Published March 4, 2016. Accessed April 6, 2016.
24. Lorenz K, Korb C, Herzog N, et al. Tolerability of 24-hour intraocular
pressure monitoring of a pressure-sensitive contact lens. J Glaucoma.
2013;22(4):311-316.
25. Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour
monitoring of intraocular pressure patterns with a contact lens sensor:
safety, tolerability, and reproducibility in patients with glaucoma. Arch
Ophthalmol. 2012;130(12):1534-1539.
26. Holló G, Kóthy P, Vargha P. Evaluation of continuous 24-hour intraocular
pressure monitoring for assessment of prostaglandin-induced pressure
reduction in glaucoma. J Glaucoma. 2014;23(1):e6-e12.
27. Tojo N, Oka M, Miyakoshi A, Ozaki H, Hayashi A. Comparison of
fluctuations of intraocular pressure before and after selective laser
trabeculoplasty in normal-tension glaucoma patients. J Glaucoma.
2014;23(8):e138-e143.
28. Costa VP, Jimenez-Roman J, Carrasco FG, Lupinacci A, Harris A. Twentyfour-hour ocular perfusion pressure in primary open-angle glaucoma. Br J
Ophthalmol. 2010;94(10):1291-1294.
29. Gordon MO, Torri V, Miglior S, et al; Ocular Hypertension Treatment Study
Group; European Glaucoma Prevention Study Group. Validated prediction
model for the development of primary open-angle glaucoma in individuals
with ocular hypertension. Ophthalmology. 2007;114(1):10-19.
30. Medeiros FA, Weinreb RN, Sample PA, et al. Validation of a predictive
model to estimate the risk of conversion from ocular hypertension to
glaucoma. Arch Ophthalmol. 2005;123(10):1351-1360.
31. Katz LJ, Steinmann WC, Kabir A, Molineaux J, Wizov SS, Marcellino G;
SLT/Med Study Group. Selective laser trabeculoplasty versus medical
therapy as initial treatment of glaucoma: a prospective, randomized trial.
J Glaucoma. 2012;21(7):460-468.
32. Realini T. Selective laser trabeculoplasty for the management of openangle glaucoma in St. Lucia. JAMA Ophthalmol. 2013;131(3):321-327.
33. Cavet ME, Vittitow JL, Impagnatiello F, Ongini E, Bastia E. Nitric oxide (NO):
an emerging target for the treatment of glaucoma. Invest Ophthalmol Vis
Sci. 2014;55(8):5005-5015.
34. Weinreb RN, Ong T, Scassellati Sforzolini B, Vittitow JL, Singh K, Kaufman PL;
VOYAGER Study Group. A randomised, controlled comparison of
latanoprostene bunod and latanoprost 0.005% in the treatment of
ocular hypertension and open angle glaucoma: the VOYAGER study.
Br J Ophthalmol. 2015;99(6):738-745.
35. Weinreb RN, Scassellati Sforzolini B, Vittitow J, Liebmann J.
Latanoprostene bunod 0.024% versus timolol maleate 0.5% in subjects
with open-angle glaucoma or ocular hypertension: the APOLLO Study.
Ophthalmology [published online ahead of print February 11, 2016].
doi:10.1016/j.ophtha.2016.01.019.
36. Wang SK, Chang RT. An emerging treatment option for glaucoma: Rho
kinase inhibitors. Clin Ophthalmol. 2014;8:883-890.
37. Wang RF, Williamson JE, Kopczynski C, Serle JB. Effect of 0.04% AR-13324,
a ROCK, and norepinephrine transporter inhibitor, on aqueous humor
dynamics in normotensive monkey eyes. J Glaucoma. 2015;24(1):51-54.
38. Budenz DL. A clinician’s guide to the assessment and management of
nonadherence in glaucoma. Ophthalmology. 2009;116(11)(suppl):S43-S47.
39. Dalton M. Sustained-release bimatoprost implant addresses challenge
of adherence. Ophthalmol Times. http://ophthalmologytimes.
modernmedicine.com/ophthalmologytimes/news/sustained-releasebimatoprost-implant-addresses-challenges-adherence. Published
January 1, 2016. Accessed March 30, 2016.
40. Allergan. Efficacy and safety of bimatoprost sustained-release (SR)
in patients with open-angle glaucoma or ocular hypertension.
ClinicalTrials.gov Web site. https://clinicaltrials.gov/ct2/show/NCT02247804.
Updated January 12, 2016. Accessed March 30, 2016.
41. Molla D, O’Connor M, Blizzard CD, et al. One-year stability of a sustained
release travoprost biodegradable hydrogel punctum plug for the
treatment of glaucoma. Invest Ophthalmol Vis Sci. 2015;56(7):5707.
42. Envisia Therapeutics. A parallel-arm, randomized, dose-ranging study of
ENV515 travoprost extended-release (XR) in subjects with bilateral ocular
hypertension or early primary open-angle glaucoma. ClinicalTrials.gov
Web site. https://clinicaltrials.gov/ct2/show/NCT02371746. Accessed
March 30, 2016.
43. Lewis R, Christie WC, Day DG, et al. Bimatoprost sustained-release
implants for glaucoma therapy: interim results from a 24-month
phase 1/2 clinical trial. Paper presented at: American Academy of
Ophthalmology 2015 Annual Meeting; November 14-17, 2015; Las Vegas,
NV. Scientific Poster 93.
44. Foldvari M. Noninvasive ocular drug delivery: potential transcorneal and
other alternative delivery routes for therapeutic molecules in glaucoma.
J Glaucoma. 2014;23(8)(suppl 1):S80-S82.
7
POST TEST
CME Monograph
To obtain AMA PRA Category 1 Credit™ for this activity, complete the
CME Post Test and course evaluation online at http://bit.ly/pressure16.
Upon successful completion of the post test and evaluation, you will
be able to generate an instant certificate of credit.
Instant CME Certificate Available With
Online Testing and Course Evaluation
at http://bit.ly/pressure16
Following are the questions that will be asked.
1. Which of the following is not a component of the definition
of POAG?
a. Optic nerve degeneration
b. Elevated IOP
c. Loss of RGCs
d. Open anterior chamber angle
2. All potential contributors to the pathophysiology of POAG
share which of the following mechanisms?
a. Raised IOP
b. Damage to the visual cortex
c. Damage to the trabecular meshwork
d. Damage to RGCs
3. Evidence in support of impaired microcirculation of the optic
nerve head as part of the pathophysiology of glaucoma
includes:
a. Optic nerve cupping
b. Optic atrophy
c. Disc hemorrhages
d. Elevated OPP
4. Established risk factors for POAG include:
a. Elevated IOP and thick central corneas
b. Increasing age and thick central corneas
c. Positive family history of glaucoma and elevated IOP
d. Young age and thin central corneas
5. Which of the following best describes the relationship between
OPP and the risk of developing POAG?
a. Elevated systolic OPP decreases the risk of POAG
b. Low diastolic OPP increases the risk of POAG
c. Low mean OPP decreases the risk of POAG
d. Low systolic OPP decreases the risk of POAG
7. For a patient with early POAG who also has benign essential
tremor and lives alone with no caregiver, which of the following
is a reasonable first-line therapy for IOP reduction?
a. Prostaglandin analogue
b. Beta-blocker
c. Laser trabeculoplasty
d. Trabeculectomy
8. For a patient with newly diagnosed end-stage POAG who has
IOP in the range of 35 mm Hg and has already lost central
visual acuity in 1 eye because of the disease, which of the
following is the best intervention for preventing blindness in
the remaining eye?
a. Prostaglandin analogue
b. Beta-blocker
c. Laser trabeculoplasty
d. Trabeculectomy
9. In clinical trials, latanoprostene bunod is thought to reduce
IOP by:
a. Decreasing aqueous humor production and increasing
trabecular (conventional) outflow
b. Increasing both uveoscleral and trabecular outflow
c. Decreasing aqueous humor production and increasing
uveoscleral outflow
d. Increasing aqueous humor production and decreasing
uveoscleral outflow
10. A significant advantage of sustained-delivery devices for
glaucoma medication is:
a. Cheaper cost
b. Less invasive than drops
c. Better adherence
d. Neuroprotection
6. What is the preferred method for determining target IOP for
glaucoma therapy?
a. Use a validated formula based on risk factor analysis
b. An educated estimate based on the risk profile of the
individual patient
c. Seek to lower IOP by 15% from untreated baseline for
most patients
d. Start a medication and see how effective it is
83
Published as a
promotional supplement to
FUNDING AND CONTENT
ASSISTANCE PROVIDED BY
MAY 2016
Choosing and Using the
AcrySof® IQ ReSTOR® IOL Family
CUSTOMIZING OPTIONS FOR INDIVIDUAL PATIENTS
CONTRIBUTORS
Stephen S. Lane, MD*
Associated Eye Care, Stillwater, Minnesota;
University of Minnesota, Minneapolis, Minnesota, USA
Mehmet Söyler, MD
Batıgöz Eye Center, Izmir, Turkey
Enrique Suárez, MD
Centro Medico Docente La Trinidad, Caracas, Venezuela
Francesco Carones, MD*
Carones Ophthalmology Center, Milan, Italy
Abhay Vasavada, MD†
Raghudeep Eye Clinic, Ahmedabad, India
Lisa Cibik, MD*
AIO Ltd, Pittsburgh, Pennsylvania, USA
Richard Potvin, OD*
Science in Vision, Burleson, Texas, USA
*Receives consulting fees from Alcon Laboratories
†
Receives grant support from Alcon Laboratories
Introduction
The AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL with ACTIVEFOCUS™ (“ReSTOR +2.5”; Model SV25T0) is the
newest addition to the AcrySof IQ family of IOLs from Alcon Laboratories, Inc.. Launched in Europe in October
2012 and approved by the FDA in the United States in April 2015, the ReSTOR +2.5 expands the AcrySof IOL
family and augments clinicians’ ability to meet patients’ specific needs based on their lifestyle and preferred
vision goals.
In a program moderated by Stephen S. Lane, MD, in April 2013, leading European cataract surgeons discussed
the ReSTOR IOLs, patient selection, surgical considerations, and early outcomes. This supplement presents the
highlights from that meeting, along with case studies, results of the ReSTOR +2.5 US FDA clinical trial, and the
thoughts of Lisa Cibik, MD, a US FDA clinical trial investigator and rapid adopter of the ReSTOR +2.5.
Trademarks are the property of Alcon Laboratories, Inc.
2
Choosing and Using the AcrySof® IQ ReSTOR® IOL Family: Customized Options for Individual Patients
The ReSTOR family: Lens profiles
more intermediate distance (from about 40 cm to about 50 cm) and
is designed to provide better intermediate vision.1,3,4 In addition, the
ReSTOR +2.5 was designed to deliver sharper distance visual acuity
The ReSTOR +2.5 is built on the same established hydrophobic
than the ReSTOR +3.0 because of modifications in its center zone
AcrySof platform as the ReSTOR +3.0. Unique design features of the
that make it behave more like a monofocal IOL than a multifocal
ReSTOR +2.5, however, give rise to some performance differences
when it comes to distance vision (Figure 2).1,2 The modifications in-
that allow surgeons to meet a broader range of patient needs.
clude a change from a diffractive to a refractive design; an increase
in diameter (from 0.86 to 0.94 mm); increased light distribution (from
The ReSTOR +2.5 IOL is designed for patients with active lifestyles who desire more range of vision than a monofocal IOL offers,
40% to 100%); and an increase in negative asphericity (from –0.1
but whose primary visual needs are for distance and intermediate
to –0.2 μm).2 The increased negative asphericity also leads to excel-
vision and who are not willing to compromise the quality of their
lent mesopic contrast sensitivity with the ReSTOR +2.5 (Figure 3).1
distance visual acuity. The ReSTOR +2.5 meets these goals and with
The increased light distribution through the center zone com-
a low rate of visual disturbances based on its novel optical design
bined with the reduced number of rings in the apodized diffractive
(ACTIVEFOCUS™) that reflects several modifications compared
multifocal zone (from 9 to 7) results in less light scattering with
with the ReSTOR +3.0 (Figure 1; Table 1).1,2
the ReSTOR +2.5 compared with the ReSTOR +3.0, reducing the
With its lower add power compared to the ReSTOR +3.0, the
potential for halos and glare.2 Bench headlight image simulations
ReSTOR +2.5 moves the patient’s preferred reading distance to a
show the reduced potential for these photic phenomena with the
Figure 1. Optic design differences: ReSTOR® +2.5 vs. ReSTOR® +3.02
ReSTOR® +2.5
Center
DISTANCE
ZONE
ReSTOR® +3.0
!PODIZED
DIFFRACTIVE
multifocal
ZONE
Outer
DISTANCE
ZONE
Reduced the add power from 3.0 D to 2.5 D by:
Center
INTERMEDIATE
ZONE
Outer
DISTANCE
ZONE
s2EDUCINGDIFFRACTIVESTEPSFROMTOAND
INCREASINGSPACING
Altered the light distribution by:
s)NCREASINGTHEDISTANCEENERGYOFTHECENTERZONE
from 40% to 100%
s2EDUCINGAPODIZEDDIFFRACTIVEAREABY
s)NCREASINGTHEOUTERDISTANCEAREABY
Table 1. Design features of the AcrySof IQ ReSTOR +2.5 and +3.0 IOLs2
+2.5 D
ReSTOR +2.5 D1
Parameter
ReSTOR +3.0 D
SV25T0
Model number
SN6AD1
+2.5 D
ADD power at IOL plane
+3.0 D
+2.0 D
ADD power at spectacle plane
+2.5 D
0.94 mm
Central ring diameter
0.86 mm
100%
Distance function of the center zone
40%
7
Number of steps
9
8.4 mm2
Apodized diffractive area
10.2 mm2
Distance 69%
Near 18.0%
Energy distribution
(3 mm IOL plane)
Distance 59%
Near 25.5%
–0.2 μm
Asphericity
–0.1 μm
+3.0 D
Published as a promotional supplement to Ophthalmology Times®
3
Figure 2. Simulated retinal images using a Badal optometer (3-mm pupil)2
Distance
80 cm (31 in)
70 cm (28 in)
60 cm (24 in)
40 cm (16 in)
ReSTOR +3.0
ReSTOR +2.5
AcrySof IQ
Figure 5. Post-op mean binocular defocus curves*,**,‡,1,4,5
Figure 3. Binocular mesopic contrast sensitivity
with glare 4–6 months postop2
67 cm 50 cm 40 cm 33 cm
(26 in) (20 in) (16 in) (13 in)
20/20
0.0
2.00
20/25
0.1
20/32
0.2
20/40
0.3
Snellen
2.25
1.75
1.50
1.25
0.4
20/50
+0.00
1.00
–0.50 –1.00 –1.50 –2.00 –2.50 –3.00 –3.50
–4.00
Refraction (D)
0.75
0.50
0.25
0.00
1.5 cpd
3 cpd
6 cpd
(n=127/130) (n=129/132) (n=116/128)
12 cpd
(n=103/117)
Spatial Frequency (cycles per degree)
AcrySof® IQ
ReSTOR® +2.5 D IOL
AcrySof® IQ
Monofocal IOL
Standard
deviation
AcrySof® IQ ReSTOR® +2.5 D IOL
(n=130) (1-month postop data)
AcrySof® IQ Monofocal IOL
(n=149) (1-month post-op data)
(n=116) (6 months post-op;
control not shown)
(n=114) (6 months post-op;
control not shown)
*AcrySof® IQ IOLs have not been compared in a head-to-head study.
**Data for AcrySof® IQ ReSTOR® +2.5 D IOL, +3.0 D IOL, and +4.0 D IOL mean
defocus curves are from the Directions for Use for each respective IOL.
‡
The methodology used to derive all defocus curve data was the same test
methodology for each IOL. No direct clinical comparison is implied.
Figure 4. Simulated headlight images in Alcon Mode Eye (5-mm pupil measured on the Optikos MTF System) 2
AcrySof IQ
ReSTOR +2.5
ReSTOR +3.0
MTF = modulation transfer function
*Trademarks are the property of their respective owners.
4
Crystalens® HD500*
Tecnis® ZMA00*
LogMAR VA
Mean Contrast Sensitivity
(Log Units)
2.50
ReSTOR +2.5 compared with some other multifocal IOLs (Figure 4).2
Binocular defocus curves show the ReSTOR +2.5 provides the same
distance vision as the AcrySof IQ monofocal IOL, but with superior
vision—almost 2 lines better—at intermediate distances (Figure 5).1
In addition to an increased range of vision, the ReSTOR +2.5
maintains contrast sensitivity comparable to the AcrySof IQ
Monofocal (Figure 3).
2
All of the above highlight that while the ReSTOR +2.5 and the
for me a few years ago, but this is not good enough for patients
anymore. I think we need to understand how important it is to
people these days to have a good range of vision.”
Dr. Vasavada went on to explain that for the majority of patients
he treats, multifocality is the logical choice. “It is of course important to customize the lens to the patient, but actually the good
news is that the ReSTOR lenses are built on a really great, proven
platform and are very versatile,” he noted.
ReSTOR +3.0 are built on the same proven hydrophobic AcrySof
platform, they are not simply the same lens with different amounts
The ideal ReSTOR +4.0 patient
of add power. Rather they are different lenses providing different
The ReSTOR +4.0 provides good uncorrected vision at distance
outcomes that together provide surgeons the opportunity to satisfy
and near. It may be a good choice for patients who spend the
the varying needs of a broad spectrum of patients.
majority of their time doing activities at less than arms length,
such as sewing, knitting, or reading, and prioritize reducing their
European surgeons’
perspectives
need for spectacles when doing those activities, but are not as
concerned about spectacle use for some intermediate and
distance activities, like driving.
Choose
Determination of the patient’s existing and long-term visual require-
The ReSTOR +3.0 is configured for distance and near vision:
ments will guide the decision on what lens is most suitable and
designed for the patient who participates in a wide variety of
most likely to result in patient satisfaction with vision after cataract
activities over a broad range of distances. The versatile ReSTOR
surgery. There are a number of different methods available for
+3.0 offers good quality vision for most lifestyle needs and is
gathering the information, including using a third party to counsel
flexible for most distances.
the patient, face-to-face discussions between the patient and the
clinician, and questionnaires.
Also available from Alcon Laboratories, Inc., are a patient edu-
“The ReSTOR +3.0 is my first choice for patients who seek true
performance at all distances from multifocal capabilities: those
who desire a broad range of vision and want decreased spectacle-
cation video that discusses cataract surgery and the various lens
dependence for near, intermediate, and distance activities,”
options and a downloadable IOL Vision Simulator application that
commented Dr. Vasavada. “In general, I would recommend this lens
illustrates to patients and their caretakers the effects of different
for patients who are easy-going and cosmetically driven, because
lens options, as well as the impact of correcting any astigmatism.
there are trade-offs with this lens, and those that are relevant, such
The video can be obtained through an Alcon Laboratories, Inc.,
as the possibility of halos, should be discussed with the patient.”
sales representative. The IOL Vision Simulator is available for
In the opinion of Dr. Francesco Carones, the best candidate for
download onto a PC for physicians in the United States (https://
the ReSTOR +3.0 lens is an older patient who is less likely to drive
www.myalcon.com/products/ surgical/acrysof-iol-vision-simulator
a lot at night and is more likely to take part in activities that require
.shtml) and as an app through the Apple Store to clinicians in other
greater near vision, like reading or playing cards. “These are
selected markets.
patients who are not detail-oriented, because we know that the
In their discussion, the European surgeons agreed that face-
only downside with the ReSTOR +3.0 implanted bilaterally is that
to-face discussions between a patient and clinician are invaluable
there’s slightly more chance that the patient will experience halos
for establishing what aspects of vision are most important to the
and night vision problems,” he added.
individual, particularly in light of evolving patient needs.
“Another important thing to bear in mind is the height of the
“It’s amazing how lifestyles are changing all across the globe,
patient,” emphasized Dr. Mehmet Söyler. “Shorter patients have
and that people are now wanting convenience in all areas of their
shorter arms, and so their reading distance will be, for instance,
lives. In terms of their vision, it is the flexibility to perform different
around 40 cm instead of 50 cm. At this distance, with the ReSTOR
activities that patients are demanding and expecting,” said Dr.
+2.5, the patient would likely need an additional reading aid, and
Abhay Vasavada. “Providing 6/6 or 20/20 vision used to be a target
so I would tend to use the ReSTOR +3.0 in my shorter patients.”
5
The opportunities of “blended vision”
The ReSTOR +2.5 was designed to maintain the quality of distance
“For patients desiring the best range of vision, especially with
vision offered by the IQ lens with the advantage of better inter-
regard to near, when using Alcon IOLs we can implant the ReSTOR
mediate vision. According to Dr. Carones, the ideal candidate
+3.0 bilaterally; for patients in whom we want to target the quality
for a bilateral ReSTOR +2.5 is a younger man or woman interested
of vision and enhance the intermediate, we’d implant the ReSTOR
in spectacle independence for distance but also for intermediate
+2.5 bilaterally,” commented Dr. Carones. “Alternatively, as another
tasks like computer usage, video editing; anything that has to be
option for customizing vision, we can implant the ReSTOR +2.5
done at 50 to 60 cm.
in the dominant eye and the ReSTOR +3.0 in the nondominant
“The strength of the ReSTOR +2.5 is the crispness of distance
vision it offers, with improved intermediate vision compared with the
eye, in a blended fashion.”
Most of the European surgeons had some experience in blending
ReSTOR +3.0,” agreed Dr. Vasavada. “I also don’t have many patients
the two ReSTOR technologies in a certain subset of patients. They
who have reported glare or halos after implantation with the ReSTOR
reported that in their experience, the range of comfort was the
+2.5. Therefore, it’s good for people who drive a lot at night, as well
best in these contralaterally implanted patients, who also have
as for active professionals, golfers, and others, who don’t mind
not reported the level of visual disturbances (such as halos) one
possibly using reading aids or increased light for near vision.”
could expect with the ReSTOR +3.0.
Dr. Vasavada said he would recommend the ReSTOR +2.5 to
patients who are already accustomed to using spectacles because
A growing population of multifocal candidates
these patients would not consider selective use of additional
Having the ReSTOR +2.5 has broadened clinicians’ options and
visual aids after implantation to be a negative outcome.
increased the number of multifocal candidates. Patients who
Alternatively, patients could use an extra light source in place
who do not want to compromise quality of distance vision would
could recommend patients install a flashlight app on their smart-
previously have been offered a monofocal lens, but are now
phones to decrease their dependence on spectacles. Then, as
eligible for the ReSTOR +2.5.
long as they had their mobile phone, the patient would always
“Historically, we did not have a multifocal option for patients
have an extra light source available and would, therefore, have
who desired a range of vision and less dependence on spectacles,
no need for additional visual aids.
but who required monofocal quality distance vision. Patients we
Patients who have residual refractive error of around –1.0 D
would once have implanted with the IQ are now happy to be using
for distance after a previous monofocal lens implantation are good
the ReSTOR +2.5 instead, because they don’t mind having to use
candidates for the ReSTOR +2.5 in the fellow eye, noted Dr. Lajja
a little additional reading aid, and their intermediate vision is much
Shastri, a colleague of Dr. Vasavada’s. This is because these patients
better,” Dr. Vasavada commented. “This additional option is allowing
are already accustomed to using visual aids and are unlikely to be
us to expand our practice.”
satisfied with the distance vision add needed.
“As I look at it, it makes a lot more sense to implant a ReSTOR
+2.5 than to use an IQ and ‘over-minus’ the patient, because I think
Dr. Vasavada’s fellow panelists reported unanimously that the
number of multifocal candidates in their practices had increased
by more than 20% since the introduction of the ReSTOR +2.5.
in that way you’d lose too much distance vision,” Dr. Lane advised.
“I think a reason for this increase is not just because of the
“The real beauty of the ReSTOR +2.5 is the crispness and the clarity
performance of this lens but also because of the increased con-
of the distance vision, and to lose that for a little bit of improve-
fidence surgeons have in being able to provide more individually
ment in the near using the ReSTOR +3.0 hasn’t been something,
tailored results for patients,” commented Dr. Lane.
in my experience, that patients are very happy about.”
“With the ReSTOR +2.5, we can dare to offer optimal vision to
almost anybody who is deemed a multifocal candidate medically—
even precision-oriented or visually demanding personality types,”
6
desire a range of vision and less dependence on spectacles
of reading aids, said Dr. Stephen Lane. He suggested that clinicians
This desire to provide tailored results for patients was illustrated
by the lack of preference for the ReSTOR +2.5 versus ReSTOR +3.0
among users.
“We are really considering the ReSTOR platform as a family
Dr. Vasavada agreed. “This means we can now move to an era
and not as standalone products; there is nobody saying ‘I will only
not just of meeting patient expectations about refractive outcomes
implant the ReSTOR +3.0,’ and nobody saying, ‘I’m done with the
but actually upgrading them, in a way that wasn’t possible with
ReSTOR +3.0, I want to have the ReSTOR +2.5 only,’” commented
only the previous models of IOL that were available.”
Dr. Carones. “I think it’s reasonable that the two IOLs will be
implanted equally frequently because the two technologies
as well as upgrading surgical techniques and instrumentation
perform differently and offer different advantages to the patient,
for the highest degree of precision.
and so they will each be needed in different scenarios. However,
since we started implanting the ReSTOR +2.5 routinely in my clin-
Preoperative considerations
ical practice, the percentage of multifocal lenses we’ve implanted
An important aspect of the perioperative assessment when
has increased and is continuing to grow. This is a reversal of the
selecting an appropriate IOL is the macular optical coherence
trend of the previous year, when we had a decrease in the per-
tomography, which is essential in patients considering multifocals.
centage of multifocal lenses we were implanting.”
This is because light scattering, which is associated with multifocal
“Personally, I don’t have a preferred lens — I have my preferred
lenses, is worse in eyes with drusen than in eyes without, and
approach, which is trying to fit a patient’s needs and expectations,
therefore multifocals should be avoided in such eyes. Another
and this brings me to implant almost the same percentage of
important consideration for multifocal lens implantation is pre-
ReSTOR +2.5 and ReSTOR +3.0 IOLs. But the reasons my per-
existing ocular surface conditions, such as meibomian gland
centage of ReSTOR implants expanded when the +2.5 became
dysfunction or anterior basement membrane dystrophy.
available are that I have much more confidence in terms of
“Probably the greatest issue I see in my multifocal IOL patients
maintaining quality of vision because of the sharpness, and
who are unhappy with their postoperative clinical result relates
because now I have many more options for customizing the
to ocular surface problems. So I would avoid implanting multifocal
results according to the patients’ needs,” Dr. Carones concluded.
lenses in eyes in which the ocular surface cannot be optimized,”
Dr. Carones said that when assessing the eye dominance is
difficult (especially for previously myopic patients) or if a patient
cautioned Dr. Lane.
Dr. Vasavada noted that he considered preoperative (and ideally
is seeking spectacle-free performance at near, he chooses bilateral
intraoperative) aberrometry to be essential for patient selection
ReSTOR +3.0 implantation. He bilaterally implants the ReSTOR +2.5
and IOL implantation with any lens. At his practice, aberrometry
in patients who are really concerned about their postoperative
is performed in the mesopic undilated pupil, and multifocal IOLs
quality of vision but are still seeking some spectacle independence,
are avoided in eyes with high aberrations and wide mesopic pupils
patients with significant activities at intermediate distances,
(Note: In India, a mesopic pupil >5 mm is rare, and so patients in
younger patients, and patients with monocular cataract who are
his clinic are rarely excluded on this basis). The aberrometer also
not willing or are not able to undergo implantation in the fellow
reports angle alpha and angle kappa values, and Dr. Vasavada’s
eye. ”However, for patients who qualify, I find myself implanting
team would also avoid multifocal IOLs in eyes with greater than
about 40% of my cases in a blended fashion,” Dr. Carones said.
0.4-mm angle alpha, for fear of decentration.
Use
when assessing a patient’s suitability for a ReSTOR lens is total
“An ideal IOL should have good intraocular behavior and a good
astigmatism, which consists of both pre-existing corneal astigma-
refractive performance,” noted Dr. Vasavada. “From a surgical
tism and surgically induced astigmatism. He recommended that
perspective, the most desirable qualities of an IOL are: compatibility
the ReSTOR +2.5 or ReSTOR +3.0 could be considered for eyes
with small incisions; ease of insertion and handling; slow, controlled
with up to 0.5 D of total astigmatism.
However, according to Dr. Vasavada, the principal consideration
unfolding; and, reliable stability. A lot of lenses would fit that descrip-
“Eyes implanted with a variety of multifocal lenses that have
tion, but not many would meet clinicians’ criteria, namely, excellent
even as little as 0.75 D of astigmatism might experience significant
biocompatibility; favorable anterior capsule opacification rate; favor-
enough visual challenges to require postoperative correction,”
able posterior chamber opacification rate; and, a time-tested per-
added Dr. Vasavada. “I measured reading speed in high resolution
formance. So the lens platform that we offer really does not change
and low- contrast sensitivity settings and both were better if even
the management we’re offering to patients. But it is the refractive
0.5 D of astigmatism was corrected versus not corrected. So it
performance that the patients’ expectations rest on, and so the
makes sense to me to correct this astigmatism wherever possible.”
way we are moving forward in this area is what we’re interested in.”
Once patients have been stratified according to their desired
There are a number of ways to achieve optimal refractive out-
visual outcomes, an appropriate lens has been selected, and the
comes and to increase ease of implantation with the ReSTOR +2.5.
physical assessments are complete, the final essential aspect
These include preoperative consideration of potential complica-
of the preoperative preparation should be to manage patients’
tions (including elimination of patients with contraindications)
expectations for the anticipated postoperative outcomes.
7
“I tell the patients undergoing ReSTOR +2.5 bilateral implantation
that they will very likely experience reduced spectacle dependence
according to the needs that they explained, but they still may need
Scheimpflug imaging so he can assess posterior corneal curvature and its effect on final astigmatism.
Dr. Richard Potvin said that he had analyzed different topography
to use glasses for some specific tasks—reading at close distance
and keratometry devices for a number of clinicians to determine
and maybe when the light is not really bright,” said Dr. Carones.
which produced the most reliable results. In general, the surgeons
“But I tell them that their vision will be uncompromised in terms
were amalgamating the outputs and including their own best
of quality.”
judgment, and this method was found to be more reliable than
“When I blend the two technologies, I tell the patients something
different. Based on my practice experience, I tell them that they will
any individual device.
The surgeons agreed that minor decentration of the ReSTOR
notice a difference between the two IOLs, with the dominant eye
lens does not have a significant impact on the patient’s visual
more focused at distance and the nondominant eye more focused
outcomes, but that it was wise to avoid decentration as much
at near but potentially more prone to visual disturbances. It’s worth
as possible. To achieve the greatest degree of centration, the
telling the patients that this difference is intentional and is not an
participants agreed that the lens should be centered on the
unintended side effect of the lenses
Purkinje image.
or the surgery itself.”
“Centering on the Purkinje image is certainly the most common
way and that’s the way you can probably stay out of trouble,”
Surgical planning and execution
stated Dr. Lane. “The material used in the ReSTOR +2.5 has a long
Accurate preoperative biometry is essential to achieving a good
enough track record that we know the lens will stay pretty much
refractive outcome and reducing the amount of visual disturbance
where you leave it, although it might move depending on the
a patient may experience, which will influence the patient’s
size of the bag.”
satisfaction with the procedure. As the ReSTOR +2.5 is built on the
Dr. Vasavada added that, if he was not satisfied with the
proven hydrophobic ReSTOR platform, surgeons familiar with the
Purkinje image on the table, he would rotate the lens and use
AcrySof technology can continue to use the surgical techniques
vertical, rather than horizontal, placement. With hydrophobic
they have refined to achieve optimal outcomes, in terms of, for
lenses it is also important to ensure that both haptics are within
example, performing the rhexis and positioning the lens.
the bag and fully opened; using capsular tension rings also
To get as close as possible to achieving emmetropia, it is crucial
helps to maintain centration and avoid posterior capsule folds.
to customize the A-constant by lens. Consider using publicly
available sources of personalized A-constants, such as consensus
Early outcomes
A-constants available from external sources. Alternatively, for their
Dr. Söyler reported that, in his early experience, around 60% to
first few cases, surgeons can consider targeting a slight degree of
70% of his patients implanted with the ReSTOR +2.5 required
residual myopia, to avoid over-correcting and leaving the patient
an additional +1.00 D of correction for reading. Dr. Suárez noted
slightly hyperopic.
that, after bilateral ReSTOR +2.5 implantation, his patients had
For example, while the manufacturer’s A-constant is 119.1, Dr.
Carones shared, “In my experience, the manufacturer’s A-constant
(119.1) does not lead to my estimated outcome and my first cases
vision and had no complaints about visual disturbances.
Dr. Söyler also reported that his patients who were implanted
were slightly hyperopic. My actual A-constant for optical coherence
contralaterally with the ReSTOR +2.5 and ReSTOR +3.0 had the
biometry with the ReSTOR +2.5 is 119.37. I suggest all surgeons
greatest distance comfort for reading from 40 cm to 75 to 80 cm
should personalize the A-constant.”
under well-lit conditions. The surgeons noted that in their experi-
The panel discussed whether it was possible to rely on one
ence using this blended vision approach, patients noticed a differ-
specific machine for the measurements, particularly in cases
ence in vision between eyes, but generally did not complain about
where machines differed. Dr. Lane commented that he relied
it (particularly in cases when patients were briefed preoperatively
more upon intraoperative aberrometry and found that it generally
to expect a difference).
produced a reliable result. Dr. Carones said he prefers using the
®
8
commented that they were happy with the quality of distance
Dr. Carones said he gave his patients subjective questionnaires,
LenStar LS 900 (Haag-Streit) for determining the amount of
and results from ratings of spectacle independence, light depend-
astigmatism, topography for axis, and the IOLMaster® (Carl
ence for reading, quality of vision, visual disturbances, and overall
Zeiss Meditec, Inc.) for axial length measurement. He also uses
satisfaction showed patients were satisfied with their outcomes.
“When I started implanting ReSTOR lenses in 2003, I had
enhancement rates of around 10%, whereas now my enhancement
Figure 6. Monocular mean distance-corrected visual
acuity measured at 4–6 months postop2
rate is around 0.5%,” he said. “This is in part because the ReSTOR
At 53 cm (intermediate)
+3.0 and +2.5 lenses are much more tolerant to residual refractive
error than the ReSTOR +4.0 was. I’ve learned the importance of
results to refine my surgical constants and surgically induced
astigmatism, and that has also helped me to consistently achieve
greater accuracy in my outcomes.”
Conclusions
“Although we have had a variety of lenses available to us for a
long time, the lens options we have had in the past have not
0.70
Mean Visual Acuity (logMAR)
maintaining a spreadsheet that I can easily update. Then I use the
covered all the needs that patients have,” said Dr. Suárez. “On
0.60
0.50
0.40
*
0.30
0.20
0.10
0.00
First Eye
one hand, we had the AcrySof IQ aspheric monofocal lens, which
gives excellent distance vision, but patients may complain about
*P<0.0001 vs. monofocal
Second Eye
Multifocal (n=155)
needing glasses for near and intermediate. On the other hand,
Monofocal (n=165)
At 40 cm (near)
we had the ReSTOR +3.0 that gives a broader range of vision for
0.70
independence. Yet some patients complain of visual disturbances.
Having a portfolio of different IOLs and solutions may enable us
to customize the IOL experience and fit the desired refractive
outcome to the expectations that the patients have.”
“Essentially, the ReSTOR +2.5 is not a ‘one size fits all’ kind of
concept,” summarized Dr. Lane. “And, the ReSTOR +2.5 will not
solve all problems for all patients. Instead, the exciting thing about
the ReSTOR +2.5 is that it gives us another tool in our chest that
we can use to try and make our patients as happy as possible.”
“To my understanding, the ReSTOR +2.5 is a really different lens
Mean Visual Acuity (logMAR)
near, intermediate, and distance with a high degree of spectacle
0.60
0.50
*
0.40
0.30
0.20
0.10
0.00
First Eye
*P<0.0001 vs. monofocal
Second Eye
Multifocal (n=155)
Monofocal (n=165)
from the ReSTOR +3.0, and is not just a different add power,” added
Dr. Carones in conclusion.“ The ReSTOR +2.5 allows the number
of patients that will benefit from multifocality to be expanded. The
with 155 subjects receiving the SV25T0 (AcrySof IQ ReSTOR +2.5 D)
ReSTOR family, therefore, represents a very powerful and complete
and 165 subjects receiving the SN60WF (AcrySof IQ Monofocal).1
platform for customizing the surgical experience for our patients
according to their individual needs and expectations.”
Compared to the controls at 4 to 6 months after the second
eye surgery, the ReSTOR +2.5 group showed:
sSUPERIORITYP<0.0001) in mean photopic monocular
ReSTOR +2.5 clinical study data
logMAR CDVA at 53 cm (Figure 6)1
sSUPERIORITYP<0.0001) in mean photopic monocular
logMAR distance-corrected near VA at 40 cm (Figure 6)1
The effectiveness and safety of the ReSTOR +2.5 was investigated
sNONINFERIORITYFORMONOCULAR#$6!ATM1
in a randomized, patient- and observer-masked, parallel group
sNOCLINICALLYRELEVANTDIFFERENCESINBINOCULARCONTRAST
1,2
study conducted at 15 sites in the United States.
Patients were
assigned to bilateral implantation of the ReSTOR +2.5 or a monofocal IOL built on the same platform—the AcrySof IQ (SN60WF,
Alcon Laboratories, Inc.).1
A total of 320 subjects were implanted in this clinical study,
sensitivity under photopic or mesopic conditions, with
or without glare (Figure 3; see page 4)1
The mean binocular defocus curve showed the ReSTOR +2.5
delivered 20/40 or better binocular vision from approximately
40 cm to distant vision.1
9
Compared with the monofocal IOL, the ReSTOR +2.5 was
approximately 2 lines better at –2.50 D (40 cm), approximately
practice. Within the first 5 months after its commercial launch,
she had already implanted the ReSTOR +2.5 in 132 eyes.
2 lines better at –2.00 D (53 cm), and more than 1 line better
Patient selection
at –3.00 D (33 cm).1
There was a low and similar incidence of severe glare in
Dr. Cibik says there is an expanded gamut of patients who can
the ReSTOR +2.5 and monofocal IOL groups (3.3% and 3.8%,
be offered the ReSTOR +2.5 because the results are so good.
1
respectively).
Therefore, potential candidates represent a diverse spectrum
with respect to vision priorities and needs.
Insights of a US surgeon
First and foremost, she considers the ReSTOR +2.5 a great
option for active patients who prioritize distance and intermediate vision and might not mind wearing readers for near tasks.
Participating as an investigator in the ReSTOR +2.5 US FDA clinical
Activities enjoyed by patients she implanted with the ReSTOR
trial, Lisa Cibik, MD, FACS, enrolled 22 patients, of which 10 were
+2.5 IOL include indoor exercise on an elliptical machine, tread-
bilaterally implanted with the ReSTOR +2.5. The outcomes from
mill, or with free weights; going to casinos; playing cards or
her center, consistent with the entire study population, showed
board games; attending movies and theater performances;
that when compared with controls implanted with the monofocal
as well as golf, tennis, and watersports.
AcrySof IQ IOL, the ReSTOR +2.5 patients achieved superior vision
In addition, because in her experience, the ReSTOR +2.5 provides
at intermediate and near distances while maintaining the same
good contrast and has a fairly low incidence of severe glare and
quality distance vision and contrast sensitivity. In addition, Dr. Cibik
halos, Dr. Cibik includes patients with occupations that require
stated that severe glare and halo were rarely reported by her
good vision at night as potential candidates. Whereas in the past
patients who received the ReSTOR +2.5.
she would not have considered a multifocal IOL to anyone who
Based on the positive experience of her clinical trial patients,
Dr. Cibik quickly adopted the ReSTOR +2.5 into her surgical
complained of halo and glare preoperatively, she also feels comfortable recommending the ReSTOR +2.5 D to some individuals
Case Studies
CASE STUDY 1
The patient: A 52-year-old female with
bilateral cataract, BCVA of 20/60– OD and
20/25– OS, and sphere of –2.50 D OD and
–2.75 D OS. She currently requires +1.00 D
of additional correction for reading.
Visual priorities: Good distance and
intermediate vision—the patient is an
avid cross-stitcher who is disabled and
relies heavily on her hobbies to find
fulfillment and enjoyment in life.
IOL strategy: Bilateral ReSTOR +2.5
Discussion: A monofocal IOL would
have satisfied some of the patient’s
requirements, and the ReSTOR +3.0
and |2.5 scored equally high for each
of the anticipated outcomes. The ReSTOR
+2.5 was selected, however, because
it offered better prospects in terms of
intermediate vision and being better
suited for patients that desire spectacle
independence.
10
Patient outcomes: At 3 months, results
in both eyes were: plano refraction, 20/20
distance UCVA, and J2 at 35 cm. The patient
has no complaints of vision disturbances.
She says she is very satisfied with her vision
and wears reading spectacles every now
and then only for extensive computer work.
CASE STUDY 2
The patient: A 56-year-old male with
bilateral cataract, BCVA of 20/50– OD and
20/30– OS, and sphere of –4.25 D OD and
–1.25 D OS. He currently requires +1.75 D
of additional correction.
Visual priorities: The patient is an
engineer and spends a great deal of time
working on the computer. Although near
vision is important to him, he states that he
spends more time on the computer than he
does reading. He desires good quality vision
and is enticed by spectacle independence
for both his work and home life.
IOL strategy: Bilateral ReSTOR +2.5
Discussion: Good distance and intermediate vision were crucial for the patient, and
the ReSTOR +2.5 was selected because it
offered better prospects for meeting those
needs and his desire for spectacle independence. Prior to coming in for his exam,
the patient was favoring the ReSTOR +2.5
based on research he had done.
Patient outcomes: At 2 months, the
patient was plano in both eyes with bilateral
UCVA of 20/20, J3 at 35 cm and 20/25 at
65 cm. While he reported seeing “concentric
rings” around lights initially after surgery,
this symptom had greatly diminished. The
patient said he rarely needs assistance
from a weak pair of readers when he uses
a certain laptop for work that has a very
small screen, but he had no need for
glasses otherwise. The patient is thankful
he achieved the vision he was hoping for
with the ReSTOR +2.5.
Table 2. Patient profiling for ReSTOR IOLs
Who is this lens for?
ReSTOR +2.5
Patients with an active lifestyle that demands more
intermediate (21 in) and distance (4 m/13 ft) vision*
s$ESIRESMOREOPPORTUNITYFORARANGEOFVISIONVERSUSMONOFOCAL
s$ESIRESINCREASEDSPECTACLEINDEPENDENCEATINANDBEYOND
s5NDERSTANDSTHATREADERMAYBENEEDEDFORnIN
ReSTOR +3.0
0ATIENTSWANTINGABROADRANGEOFVISION
s"ALANCEOFACTIVITIESATNEARINTERMEDIATEANDDISTANTFOCALPOINTS
sSeeks true performance at all distances from multifocal capabilities:
DESIRESFULLRANGEOFVISIONFROMINCMTODISTANCEWITH
GREATESTOPPORTUNITYOFSPECTACLEINDEPENDENCEATALLDISTANCES
!CTIVELIFESTYLEPATIENTSPARTICIPATEINACTIVITIESTHATREQUIREINTERMEDIATEANDDISTANCEVISIONSUCHASGOLFTENNISTHEATERANDDRIVING
with that history after undertaking an in-depth evaluation of their
priorities and providing thorough counseling about outcomes.
Older, less active patients are another group of excellent can-
“Particularly good candidates are patients who were in monovision prior to cataract surgery,” she said.
To aid in the IOL selection decision, Dr. Cibik’s patients complete
didates for the ReSTOR +2.5 if they have needs for good quality
questionnaires that are designed to elicit their current visual
distance and intermediate vision. In addition, Dr. Cibik said that
difficulties; information about their personality, hobbies, computer
she has implanted the ReSTOR +2.5 in patients with a history of
usage, and other daily activities; their desire for spectacle inde-
corneal refractive surgery, including postLASIK and postRK patients.
pendence; and their perceived ideal outcomes.
“While I was leery previously about using a multifocal IOL in
Counseling for patients who are deemed good candidates for
patients who had keratorefractive surgery and my experience in
the ReSTOR +2.5 informs them they should have very good quality
these individuals is limited, I think the ReSTOR +2.5 is a reasonable
distance and intermediate vision while making sure they under-
option as long as the patient is very well counseled,” Dr. Cibik said.
stand the potential need for readers, similar to what they would
Considering its performance and advantages, Dr. Cibik said she
have used as an early presbyope.
is now using the ReSTOR +2.5 instead of an accommodative lens
in any patient who wants good quality distance and intermediate
Surgical approach and pearls
vision, does not mind wearing reading glasses for near tasks,
Knowing that achieving optimal outcomes after cataract surgery
and is not a candidate for a toric IOL.
depends on a comprehensive preoperative evaluation and
“In my opinion, the ReSTOR +2.5 provides near vision that
accurate biometry, Dr. Cibik performs refraction and glare testing,
is at least as good if not better than some other lenses. In fact,
spectral domain optical coherence tomography imaging of the
some of my ReSTOR +2.5 patients can read J1 or J2 with good
retina, and corneal topography. She also uses the LenStar LS 900
lighting. In addition, I find the implantation is easy with the
and VERION™ Reference Unit (Alcon Laboratories, Inc.) to obtain
ReSTOR +2.5,” she said.
key measurements.
The ReSTOR +2.5, however, has not replaced the ReSTOR +3.0.
All patients are also evaluated thoroughly for ocular surface
Dr. Cibik said that with its higher add power, the ReSTOR +3.0
disease, including measurement of tear osmolarity, and anyone
meets the needs of patients who for whatever reason want to be
diagnosed with meibomian gland dysfunction/dry eye is started
less spectacle dependent for close vision and/or who have less
on an individually tailored regimen, which might include artificial
dependency on good nighttime driving vision (Table 2).
tears, punctal plugs, topical cyclosporine, and/or oral vitamin
In some cases, Dr. Cibik reports using a blended vision approach,
supplements for ocular surface support.
using the ReStor +3.0 in the nondominant eye and the ReStor +2.5
“It is extremely important to be very aggressive treating dry
in the dominant eye when patients need a broad and more custom-
eye to optimize the ocular surface before implanting a multifocal
ized range of vision and desire as limited spectacle use as possible.
IOL because these patients have high outcomes expectations,”
Dr. Cibik said she has used blended vision in patients who
previously underwent unilateral cataract surgery with implantation
Dr. Cibik said.
Using data from the eyes implanted during the FDA clinical trial
of the ReSTOR +3.0. In addition, she is using it as a planned pro-
and shortly after product commercialization, Dr. Cibik optimized
cedure for select patients who need bilateral cataract surgery.
her A-constant from the nominal value of 119.1 to 119.294.
11
“By doing so, I improved the predictability of my refractive outcomes, which typically target between plano and –0.25 D,” she said.
“Surgeons just getting started with the ReSTOR +2.5 should refer
ReSTOR +2.5: The surgeon- and
patient-friendly option
Dr. Cibik concluded that the ReSTOR +2.5 broadens opportunities
to the A-constant found on the User Group for Laser Interference
to meet the vision needs of cataract surgery patients. With its ease
Biometry (ULIB) website [ocusoft.de/ulib/] until they have collected
of use and excellent outcomes, surgeons can feel completely
enough data for personalization.”
comfortable adopting it into their practice, she said.
Dr. Cibik uses the ASCRS (American Society of Cataract and
“The features of the ReSTOR +2.5 make it a particularly great
Refractive Surgery) calculator to help guide IOL power selection
option for surgeons wanting to begin offering presbyopia-cor-
in patients with a history of corneal refractive surgery, and intra-
recting IOLs, especially anyone who is already using other AcrySof
operative manual retinoscopy is used for validation in those cases.
lenses. All surgeons, however, can be confident about achieving
Intraoperatively she uses the image from the VERION™ Digital
success with the ReSTOR +2.5 as long as they are thorough in
Marker in the operating microscope to guide placement of the
their preoperative evaluation, planning, and counseling so that
ReSTOR IOL, nudging the lens so that the center is slightly toward
patients are properly selected and have appropriate expectations
the nasal side of the pupil center.
for their outcomes.”
Astigmatism is evaluated preoperatively by looking at the refraction,
topography, and biometry. Dr. Cibik considers patients candidates for
the ReSTOR +2.5 D if they have up to 1.0 D of corneal astigmatism,
and she addresses astigmatism at the time of surgery as needed.
Second eye surgery is typically done within 1 week using the
measured refraction in the first eye to determine if any adjustment
is needed in the suggested IOL power.
REFERENCES
1. AcrySof® IQ ReSTOR +2.5 D Multifocal IOL Directions for Use. Alcon Laboratories, Inc.;
Fort Worth, TX.
2. Alcon Laboratories, Inc., data on file.
3. Pedrotti E, Mastropasqua R, Passilongo M, et al. Comparison of two multifocal intraocular lens designs that differ only in near add. J Refract Surg. 2014;30(11):754–760.
Fort Worth, TX.
Fort Worth, TX.
AcrySof® IQ ReSTOR® Family of IOLs – Important Product Information
device to the sale by or on the order of a
physician.
INDICATIONS: The AcrySof® IQ ReSTOR®
Posterior Chamber Intraocular Lens (IOL) is
intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients
with and without presbyopia, who desire
near, intermediate and distance vision with
increased spectacle independence. The lens
is intended to be placed in the capsular bag.
WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judg-
ment should be used by the surgeon to decide the risk/benefit ratio before implanting
a lens in a patient with any of the conditions
described in the Directions for Use labeling.
Physicians should target emmetropia, and
ensure that IOL centration is achieved. Care
should be taken to remove viscoelastic from
the eye at the close of surgery.
Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. As
with other multifocal IOLs, visual symptoms
may be significant enough that the patient
will request explant of the multifocal IOL.
Spectacle independence rates vary with all
multifocal IOLs; as such, some patients may
need glasses when reading small print or
looking at small objects.
Clinical studies with the AcrySof® ReSTOR®
lens indicated that posterior capsule opacification (PCO), when present, developed earlier
into clinically significant PCO. Prior to surgery,
physicians should provide prospective patients
with a copy of the Patient Information Brochure available from Alcon for this product
informing them of possible risks and benefits
associated with the AcrySof® IQ ReSTOR® IOLs.
Studies have shown that color vision discrimination is not adversely affected in indi-
viduals with the AcrySof® Natural IOL and
normal color vision. The effect on vision of
the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired
color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy,
chronic uveitis, and other retinal or optic
nerve diseases) has not been studied. Do
not resterilize; do not store over 45° C; use
only sterile irrigating solutions such as BSS®
or BSS PLUS® Sterile Intraocular Irrigating
Solutions.
ATTENTION: Reference the Directions for
Use labeling for a complete listing of indications, warnings and precautions.
VERION™ Image Guided System – Important Product Information
VERION™ Reference Unit
and VERION™ Digital Marker
device to sale by, or on the order of, a physician.
INTENDED USES: The VERION™ Reference
Unit is a preoperative measurement device
that captures and utilizes a high-resolution
reference image of a patient’s eye. In addition, the VERION™ Reference Unit provides
pre-operative surgical planning functions to
assist the surgeon with planning cataract
surgical procedures. The VERION™ Reference Unit also supports the export of the
reference image, preoperative measurement data, and surgical plans for use with
the VERION™ Digital Marker and other compatible devices through the use of a USB
12
memory stick. The VERION™ Digital Marker
links to compatible surgical microscopes to
display concurrently the reference and
microscope images, allowing the surgeon
to account for lateral and rotational eye
movements. In addition, details from the
VERION™ Reference Unit surgical plan can
be overlaid on a computer screen or the
physician’s microscope view.
proper functioning of the VERION™ Digital
Marker: changes in a patient’s eye between
pre-operative measurement and surgery, an
irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloated
conjunctiva due to anesthesia). In addition,
the use of eye drops that constrict sclera
vessels before or during surgery should be
avoided.
CONTRAINDICATIONS: The following conditions may affect the accuracy of surgical
plans prepared with the VERION™ Reference Unit: a pseudophakic eye, eye fixation
problems, a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the
reference measurement as this may interfere with the accuracy of the measurements.
The following conditions may affect the
WARNINGS: Only properly trained personnel should operate the VERION™ Reference
Unit and VERION™ Digital Marker. Use only
the provided medical power supplies and
data communication cable. Power supplies
for the VERION™ Reference Unit and the
VERION™ Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do not cover
any of the component devices while turned
on. The VERION™ Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or reflected beam.
PRECAUTIONS: To ensure the accuracy of
VERION™ Reference Unit measurements,
device calibration and the reference measurement should be conducted in dimmed
ambient light conditions. Only use the
VERION™ Digital Marker in conjunction with
compatible surgical microscopes.
ATTENTION: Refer to the user manuals
for the VERION™ Reference Unit and the
VERION™ Digital Marker for a complete description of proper use and maintenance
of these devices, as well as a complete list
of contraindications, warnings and precautions.
© 2016 Novartis
5/16
US-RES-15-E-1066

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