take-home - Modern medicine

Transcription

CUTTING-EDGE ADVANCEMENTS
CLINICAL DIAGNOSIS
OphthalmologyTimes.com
FOLLOW US ONLINE:
Surgery
SINGLE-PORT PPV
FOR SAFE PHACO IN
CROWDED CHAMBER
ASTORIA, NY :: ONE-PORT PARS plana
vitrectomy (PPV) is the only effective
technique to deepen the anterior chamber when performing phacoemulsification in crowded eyes, according
to R.J. Mackool Jr., MD, assistant director of the Mackool Eye Institute
and Laser Center in Astoria, NY. “If
there is any doubt about adequate
chamber depth, the surgeon should
err on the side of safety by performing a one-port PPV,” Dr. Mackool Jr.
explained.
( See story on page 14 : Single-port PPV )
Special Report
NAVY STUDY ASSERTS
EXCELLENT OUTCOMES
FOR LASIK SURGERY
RESULTS FROM THE PROWL-1 Study
provide further evidence that LASIK
is associated with excellent objective clinical and patient-reported outcomes, but also serve as a reminder
that no surgical procedure is without
risk. PROWL-1, conducted at the Navy
Refractive Surgery Center, San Diego,
represents phase II of the LASIK Quality
of Life Collaboration Project that was
undertaken as a government partnership involving the FDA, National Eye
Institute, and Department of Defense.
( See story on page 25 : PROWL-1 )
SURGERY
March 15, 2015 VOL. 40, NO. 5
DRUG THERAPY
Toric IOLs + abnormal
corneas: Do they mix?
Patient selection, expectation management,
adjunctive procedures paramount to success
“Corneal staining,
hyperosmolarity,
and rapid tear
film break-up time
can significantly
affect topography
and keratometry
calculations,
creating IOL errors.”
— Christopher E. Starr, MD
(FIGURE 1) Inferior corneal
staining from dry eye
disease in a preoperative
cataract surgery patient.
(Image courtesy of Christopher E.
Starr, MD)
By Lynda Charters;
Reviewed by Christopher E. Starr, MD
NE W YORK ::
CAREFUL PATIENT SELECTION is the
foundation for successful outcomes when implanting premium toric IOLs in some cases with corneal pathologies. To obtain the best visual results,
other procedures may be required before or after
cataract surgery.
“When implanting premium IOLs in patients with
abnormal corneas, there is really no right or wrong,”
said Christopher E. Starr, MD, associate professor
of ophthalmology and director, refractive surgery
service, Weill Corneal Medical College, New York
Presbyterian Hospital, New York.
Having said that, Dr. Starr’s personal style
when dealing with higher-risk eyes tends toward
the more conservative in an area in which the patients have unusually high expectations regarding
visual outcomes.
“No cornea is static—all corneas change over
time,” he said. “Normal corneas tend to change very
slowly and predictably over time—normal corneas
have regular astigmatism.”
Dr. Starr cited a study by Koch et al. which
noted that normal corneas drift from with-therule to against-the-rule astigmatism over time—
which required adjusting the toric IOL power accordingly. These eyes do well with premium IOLs.
“On the other hand, abnormal corneas tend to
change rapidly and unpredictably and can have substantial irregular astigmatism,” he said. “In these
eyes, IOL selection is like shooting at a moving target. IOL selection is less precise and managing expectations in these cases is paramount.”
( Continues on page 22 : Abnormal corneas )
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IMPORTANT SAFETY INFORMATION
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to the brief summary of Prescribing Information on adjacent page.
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MARCH 15, 2015 :: Ophthalmology Times
3
contents
10
InDispensable
Practice Management
41 FASHION-FORWARD
48 STAFF RESTRUCTURE: TEARS,
DRAMA NOT INCLUDED
Why having a pulse on eyewear trends
is vital to dispensary profitability,
customer base
32
Surgery
8 5 PRACTICE PEARLS FOR
ENDOTHELIUM PROTECTION
Phaco, viscoelastics, I&A, intracameral/
postoperative drugs all play a role
Special Report
16 EPITHELIUM-ON CXL
May make customized treatment more
attractive for therapeutic indications
Technology
34 NEW TOOL MARKS INCISION
SITES FOR PPV
Setting lets incision spots be placed
correct distance apart with accuracy
Drug Therapy
35 ASPIRIN USE NOT TIED
TO AMD PROGRESSION
Trials generally show protective effect
Clinical Diagnosis
When the person you depend on quits,
how do you choose the best replacement?
any persistent corneal ulceration where a steroid has
been used or is in use. Fungal culture should be taken
when appropriate.
BRIEF SUMMARY OF PRESCRIBING INFORMATION
INDICATIONS AND USAGE
Ocular Surgery
DUREZOL®
a topical corticosteroid, is indicated for the treatment
surgery.
Endogenous Anterior Uveitis
DUREZOL® Emulsion is also indicated for the treatment
of endogenous anterior uveitis.
DOSAGE AND ADMINISTRATION
Ocular Surgery
Topical Ophthalmic Use Only
DUREZOL® Emulsion is not indicated for intraocular
administration.
Contact Lens Wear
DUREZOL® Emulsion should not be instilled while
wearing contact lenses. Remove contact lenses prior to
instillation of DUREZOL® Emulsion. The preservative in
DUREZOL® Emulsion may be absorbed by soft contact
lenses. Lenses may be reinserted after 10 minutes
following administration of DUREZOL® Emulsion.
ADVERSE REACTIONS
Adverse reactions associated with ophthalmic steroids
include elevated intraocular pressure, which may be
associated with optic nerve damage, visual acuity and
eye 4 times daily beginning 24 hours after surgery
postoperative period, followed by 2 times daily for a
week and then a taper based on the response.
eye 4 times daily for 14 days followed by tapering as
clinically indicated.
DOSAGE FORMS AND STRENGTHS
DUREZOL®
a sterile preserved emulsion for topical ophthalmic
administration.
CONTRAINDICATIONS
The use of DUREZOL® Emulsion, as with other
ophthalmic corticosteroids, is contraindicated in most
active 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 disease
of ocular structures.
WARNINGS AND PRECAUTIONS
IOP Increase
Prolonged use of corticosteroids may result in
glaucoma with damage to the optic nerve, defects
be used with caution in the presence of glaucoma. If
this product is used for 10 days or longer, intraocular
pressure should be monitored.
Cataracts
Use of corticosteroids may result in posterior
subcapsular cataract formation.
Delayed Healing
The use of steroids after cataract surgery may delay
healing and increase the incidence of bleb formation.
In those diseases causing thinning of the cornea or
sclera, perforations have been known to occur with
the use of topical steroids. The initial prescription
and renewal of the medication order beyond 28 days
should be made by a physician only after examination
slit lamp biomicroscopy and, where appropriate,
Bacterial Infections
Prolonged use of corticosteroids may suppress
the host response and thus increase the hazard
of secondary ocular infections. In acute purulent
conditions, steroids may mask infection or enhance
existing infection. If signs and symptoms fail to
improve after 2 days, the patient should be reevaluated.
Viral Infections
Employment of a corticosteroid medication in the
treatment of patients with a history of herpes simplex
requires great caution. Use of ocular steroids may
prolong the course and may exacerbate the severity
of many viral infections of the eye (including herpes
simplex).
Fungal Infections
Fungal infections of the cornea are particularly prone
to develop coincidentally with long-term local steroid
application. Fungus invasion must be considered in
Nursing Mothers
It is not known whether topical ophthalmic
administration of corticosteroids could result in
quantities in breast milk. Systemically administered
corticosteroids appear in human milk and could
suppress growth, interfere with endogenous
corticosteroid production, or cause other untoward
®
Emulsion is administered to a nursing woman.
Pediatric Use
DUREZOL® Emulsion was evaluated in a 3-month,
multicenter, double-masked, trial in 79 pediatric patients
(39 DUREZOL® Emulsion; 40 prednisolone acetate) 0 to 3
years of age for the treatment of inflammation following
cataract surgery. A similar safety profile was observed in
pediatric patients comparing DUREZOL® Emulsion to
prednisolone acetate ophthalmic suspension, 1%.
secondary ocular infection from pathogens including
herpes simplex, and perforation of the globe where
there is thinning of the cornea or sclera.
Geriatric Use
Ocular Surgery
Ocular adverse reactions occurring in 5-15% of
subjects in clinical studies with DUREZOL® Emulsion
included corneal edema, ciliary and conjunctival
hyperemia, eye pain, photophobia, posterior capsule
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, and Impairment of
Fertility
in vitro in the Ames
test, and in cultured mammalian cells CHL/IU (a
been observed between elderly and younger patients.
female Chinese hamsters). An in vivo micronucleus
ocular adverse reactions occurring in 1-5% of subjects
included reduced visual acuity, punctate keratitis,
Treatment of male and female rats with subcutaneous
occurring in < 1% of subjects included application
site discomfort or irritation, corneal pigmentation and
striae, episcleritis, eye pruritus, eyelid irritation and
crusting, foreign body sensation, increased lacrimation,
macular edema, sclera hyperemia, and uveitis. Most of
these reactions may have been the consequence of the
surgical procedure.
mating did not impair fertility in either gender. Long
term studies have not been conducted to evaluate the
A total of 200 subjects participated in the clinical trials
for endogenous anterior uveitis, of which 106 were
exposed to DUREZOL® Emulsion. The most common
adverse reactions of those exposed to DUREZOL®
Emulsion occurring in 5-10% of subjects included
blurred vision, eye irritation, eye pain, headache,
increased IOP, iritis, limbal and conjunctival hyperemia,
punctate keratitis, and uveitis. Adverse reactions
occurring in 2-5% of subjects included anterior
as suppression of body weight gain; a decrease
in lymphocyte count; atrophy of the lymphatic
photophobia, and reduced visual acuity.
USE IN SPECIFIC POPULATIONS
Pregnancy
Teratogenic E
shown to be embryotoxic (decrease in embryonic
and teratogenic (cleft palate and skeletal) anomalies
when administered subcutaneously to rabbits during
organogenesis at a dose of 1–10 mcg/kg/day. The
to be a teratogenic dose that was concurrently found
in the toxic dose range for fetuses and pregnant
females. Treatment of rats with 10 mcg/kg/day
subcutaneously during organogenesis did not result in
any reproductive toxicity, nor was it maternally toxic.
At 100 mcg/kg/day after subcutaneous administration
in rats, there was a decrease in fetal weights and
human doses of DUREZOL® Emulsion, since DUREZOL®
Emulsion is administered topically with minimal
Animal Toxicology and/or Pharmacology
In multiple studies performed in rodents and
non-rodents, subchronic and chronic toxicity tests
thinning of the skin; all of which were due to the
pharmacologic action of the molecule and are well
The NOEL for the subchronic and chronic toxicity tests
were consistent between species and ranged from
1–1.25 mcg/kg/day.
PATIENT COUNSELING INFORMATION
Risk of Contamination
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 emulsion.
Use of the same bottle for both eyes is not
recommended with topical eye drops that are used in
association with surgery.
Risk of Secondary Infection
becomes aggravated, the patient should be advised to
consult a physician.
Contact Lens Wear
DUREZOL® Emulsion should not be instilled while
wearing contact lenses. Patients should be advised to
remove contact lenses prior to instillation of DUREZOL®
Emulsion. The preservative in DUREZOL® Emulsion may
be absorbed by soft contact lenses. Lenses may be
reinserted after 10 minutes following administration of
DUREZOL® Emulsion.
Revised: May 2013
U.S. Patent 6,114,319
were not measured in the reproductive animal studies.
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134 USA
1-800-757‐9195
Manufactured By:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134 USA
or
Catalent Pharma Solutions
Woodstock, IL 60098
pregnancy has not been evaluated and cannot rule
out the possibility of harm, DUREZOL® Emulsion should
© 2014 Novartis
©2014 Novartis
38 PEDIG STUDIES: BINOCULAR
TREATMENT, PATCHING
Analyzing how approaches stack up
In This Issue
4 GUEST EDITORIAL
43 MARKETPLACE
Manufactured For:
3/14
1/15
DUR14031JAD
DUR14090JAD
4
guest editorial
MARCH 15, 2015 ◾ VOL. 40, NO. 5
CONTENT
The lost art of medicine
Technology is great, but don’t forget about the human touch
By Joseph Tauber, MD
Dr. Tauber is medical director of Tauber
Eye Center, Kansas City, MO, where he
is an anterior segment subspecialist and
refractive surgeon.
P: 816/531-910
E: jt@taubereye.com
www.taubereye.com
I WAS PRIVILEGED TO RECEIVE
my medical and ophthalmology education
in excellent academic centers, from worldrenowned faculty and physicians. The best
among these clinician-scientists were often
called dinosaurs, because “they just don’t make
people like that anymore.”
We learned far more than just the science
of medicine; we learned the art, the humanity,
and the responsibility that comes to those who
choose careers in health care. Like most physicians in training, we focused on the science,
the knowledge we would need to practice, but
the other aspects of these “Giants” soaked inside by osmosis.
I could never be more than a pale shadow of
these dinosaurs. However, as my hair becomes
more and more gray, I find my thoughts are becoming more “old school” and I understand
the wisdom of my great teachers. Part of our
responsibility is to give back, to train the next
generations of physicians. This notion needs to
become part of the “me” generation in the digital age.
In medical school, I was taught that it is possible to make a diagnosis based on history
alone, and that one could anticipate a diagnosis
even before performing an examination. I was
also taught that it is equally possible to make
a diagnosis from a nonverbal patient, without any provided history, based on a thorough
exam alone.
While both statements are true, I have had
enough diagnostic “surprises” that I have
learned to keep my mind open until I have
collected all the observations I can. A broad
knowledge base is important. The eyes only see
what the brain knows.
At the same time, our brains can get in the
way of our eyes. There is an old Zen saying
(poorly paraphrased here) that once we label a
thing, our eyes are no longer open. It is in the
time before we assign a label to something that
we truly are open to seeing it and understanding it.
Listening and observing are skills that make
the best clinicians. This principle is one that
has guided my career in medicine. Of late,
this concept seems particularly relevant to
the treatment of patients with ocular surface
disease.
The practice of medicine in 2015 is so different from what I was taught in medical school.
Whether we have advanced the level of care we
provide is a matter of opinion.
OLD WAY:
> Look at your patient (overall body exam,
habitus, emotional mood, etc.)
> Listen to your patient—take a history.
Listen more than speak.
> Perform your clinical exam.
> Perform diagnostic tests as needed to narrow
differential diagnosis. Does each test ordered
help choose between treatment options?
What will you do differently if the test
is positive versus negative?
> Prescribe and explain treatment,
schedule follow-up.
NEW WAY:
> Log into EMR.
> Check if pre-testing technician performed
tear osmolarity, MMP-9, Adeno-Plus, LipiView
interferometry, corneal topography, wavefront
analysis, endothelial count.
> Verify that appropriate diagnoses
(and modifiers) were coded to ensure proper
reimbursement for those tests that are covered
and do not require ABN waiver.
> Turn to do slit lamp exam. Tell scribe
what to record.
> Tell scribe what “patient education”
to provide and record in EMR to satisfy
Meaningful Use 2 criteria. Exit the room.
> Check time to be sure you remain on schedule.
I like to think I am skilled in the evaluation and management of both common and
Continues on page 6 : Guest editorial
Chief Medical Editor Peter J. McDonnell, MD
Group Content Director Mark L. Dlugoss
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6
guest editorial
GUEST EDITORIAL
( Continued from page 4 )
complex ocular surface conditions, and
I regularly lecture on this topic at local
and national venues, including the annual meeting of the American Academy of
Ophthalmology.
surface-related discomfort (a term I favor
over “dry eye” or “tear film dysfunction”)
than we were 30 years ago?
I have heard it said that the instruments
we mainly rely on for ocular diagnosis have
remained unchanged for at least 30 years
(i.e., slit lamps, tonometers, direct and indirect ophthalmoscopes). I believe that the
best diagnostic tool clinicians possess is
even older, and is also the handiest—the
‘Listening and observing are skills that make the
best clinicians.’ — Joseph Tauber, MD
I am an active clinical researcher. I strive
to stay current on the latest diagnostic tools
available, which have rapidly multiplied
over the past decade. Beyond our ability to
measure tear production, osmolarity, MMP9, IgE and lactoferrin levels, we can measure lipid layer thickness, visualize meibomian glands and even dynamically assess tear film stability and induced corneal
aberrations.
Soon, we will be measuring tear film cytokines and other aspects of the all-important tear film. But, are we any better at helping our patients with complaints of ocular
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Caught between a husband and
a wife
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2 When a doctor is at the center
one we have between our ears.
Despite all the forces encouraging us to
use the latest tests and instruments for dry
eye, I find my clinical judgment remains my
most useful tool.
Ocular surface disease (OSD) is a phrase
that encompasses allergic conditions, lid
margin diseases, and tear deficiency/dysfunction conditions. Likely, dysfunctional
blinking, neurotrophic neuropathic pain
and hormonal conditions are involved in the
same symptom complex as the more widely
recognized diseases, too.
For me, much of medicine is pattern rec-
Digital App
ognition, and a well-taken history rather
easily separates allergic and lid margin diseases from the overall group of OSD. Most
of the available testing available—and I own
most of them—can confirm or quantitate
one aspect (e.g., low lipid thickness or abnormal osmolarity), but do not differentiate
the subgroups and do not help me choose an
effective treatment plan.
I institute a stepladder plan for lid margin
disease when I see it at the slit lamp, escalating from lid hygiene to oral anti-inflammatory/oil-liquefactive medications to mechanical means (probing or LipiFlow, according to duct patency). I institute a stepladder plan for insufficient tear production
when history informs me that particular
environments or tasks generate irritative
symptoms.
To quote something I read from Dr. Darrell White: “You can’t make an asymptomatic patient feel better.”
Treating data and not patient complaints
will not help achieve satisfied patients.
Clinicians should practice the art of medicine, which seems harder in these times of
declining reimbursements and the proliferation of new shiny toys we can use, and
charge for, to measure aspects of the tear
film. If that sounds like advice from a dinosaur, I’m proud of it. Q
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courses before attempting to create a corneal resection. The use of the iFS Laser for IEK procedures or for arcuate incisions is not recommended for certain
patients. Please see the Operator’s Manual for a complete listing. ADVERSE EVENTS: Possible complications resulting from LASIK flap creation include
corneal edema/inflammation, corneal pain, epithelial ingrowth, epithelial defect, infection, photophobia, flap decentration, incomplete flap creation, flap tearing
or incomplete lift-off, free cap, inflammation, thin or thick flaps, or flap striae. Arcuate incision complications include corneal edema/inflammation, corneal pain,
epithelial ingrowth, epithelial defect, infection, photophobia or corneal endothelium perforation. Transient Light Sensitivity Syndrome (TLSS) and Peripheral Light
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severe light sensitivity which manifests between 2 and 6 weeks postoperatively. PLS (.03% of patients) is a temporary phenomenon whereby patients report
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©2014 Abbott Medical Optics Inc. Santa Ana, CA 92705 2013.03.11-RF6551
8
surgery
Five pearls for endothelium
protection in cataract surgery
Phacoemulsification, viscoelastics, I&A, intracameral/postoperative drugs all play a role
By Lynda Charters; Reviewed by Terry Kim, MD
DURHAM, NC ::
rotecting the endothelium during cataract surgery can be a
challenge for seasoned or novice surgeons alike depending on
the status of patients, according
to Terry Kim, MD.
Factors are as varied as the
patients’ cases, said Dr. Kim, professor of
ophthalmology, Duke University School of
Medicine, and director of fellowship programs, Cornea and Refractive Surgery Services, Duke
University Eye Center, Durham, NC.
Long-recognized non-corneal risk factors to watch out
for to prevent injury to the
Dr. Kim
corneal endothelial cells are
a shallow or crowded anterior chamber, the
density of the nucleus, small pupils, the volume of the infusion, the amount of ultrasound
energy used, and the type of IOL to be implanted, he said.
Even more important are the following corneal characteristics that may be predictive
of problems—i.e., older patient age characterized by a lower endothelial cell density
and the presence of Fuchs’ dystrophy and
diabetes mellitus, he noted.
P
stripping endothelial keratoplasty (DSEK)
triple procedure that includes corneal transplant, cataract removal, and IOL insertion.
During preoperative testing, surgeons should
be aware of any symptoms the patient may
have—the severity of guttae (specular reflection), stromal edema, lens density, and
the anterior chamber depth observed during
the slit lamp examination, and any other comorbidities. The examination also includes
pachymetry and specular microscopy.
Dr. Kim offered five pearls for endothelium
protection that include consideration of the:
> Phacoemulsification techniques
Surgeons have a number of factors to consider in their decision making during the
preoperative testing. Specifically, in highrisk patients, they must decide whether to
perform a cataract extraction or a Descemet’s
NON-CORNEAL
1.
2.
3.
4.
5.
6.
Shallow/crowded anterior chamber
Density of nucleus
Small pupil
Infusion volume
Amount of ultrasound energy
Type of IOL
and technology.
>
>
>
>
Use of viscoelastics.
CORNEAL
Irrigation and aspiration (I&A) techniques.
1. Older age (lower endothelial cell density)
2. Fuchs’ dystrophy
3. Diabetes mellitus
Intracameral medications.
Postoperative medications.
PH ACOEMULSIFIC ATION
TECHNOLOGY
The phacoemulsification technique that includes a horizontal or vertical chop procedure
reduces both the energy used in the eye and
the ultrasound time.
“The benefits of ultrasound power modulation are greatly reduced
repulsion, decreased turbulence, enhanced followability, lower risk of thermal
burns, and less endothelial
trauma, which results in less
total energy used and less
endothelial cellular loss at
6 months postoperatively,”
Dr. Kim said.
The power phacoemulsification modulation capability, he noted, is available in the following platforms: Alcon Centurion Torsional
IP, the AMO Signature Ellips FX, and the
Bausch + Lomb Stellaris with Hyperburst
technology.
‘The importance of removing
all nuclear fragments
cannot be overemphasized.’
— Terry Kim, MD
Patient Risk
Factors for Corneal
Endothelial Cell Injury
Havashi K et al. Risk factors for corneal endothelial injury during
phacoemulsification. J Cataract Refract Surg. 1996;22:1079-1084.
Phacoemulsification technology includes
the relatively recent introduction of femtosecond laser-assisted cataract surgery.
With femtosecond cataract surgery, the average phacoemulsification time has been
decreased substantially from an average
power of about 23.5% with phacoemulsification-only to about 13.5% with the more
advanced technology. The effective phacoemulsification time also was reduced from
~1 minute to <30 seconds, respectively.
VISCOELASTIC DEVICES
Three types of viscoelastics are used depending on the case:
> Dispersives, such as Viscoat (Alcon Laboratories), Healon D (Abbott Medical Optics
[AMO]), and Ocucoat (Bausch + Lomb) that
Continues on page 11 : Endothelium
NOT A HOLE.
A PATHWAY
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reestablish physiologic outflow. iStent is more than just an innovative trabecular
micro-bypass stent, it is a step forward to safe and effective glaucoma treatment.
To learn more, contact Glaukos at 800.452.8567 or visit www.glaukos.com.
INDICATION FOR USE. The iStent® Trabecular Micro-Bypass Stent (Models GTS100R and GTS100L) is indicated for use in conjunction with cataract surgery for the reduction of
intraocular pressure (IOP) in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication. CONTRAINDICATIONS. The iStent®
is contraindicated in eyes with primary or secondary angle closure glaucoma, including neovascular glaucoma, as well as in patients with retrobulbar tumor, thyroid eye disease,
Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. Gonioscopy should be performed prior to surgery to
exclude PAS, rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent
and pose a hazard. The iStent® is MR-Conditional meaning that the device is safe for use in a specified MR environment under specified conditions; please see label for details.
PRECAUTIONS. The surgeon should monitor the patient post-operatively for proper maintenance of intraocular pressure. The safety and effectiveness of the iStent® has not been
established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, chronic inflammation, or an abnormal
anterior segment, in pseudophakic patients with glaucoma, in patients with pseudoexfoliative glaucoma, pigmentary, and uveitic glaucoma, in patients with unmedicated IOP
less than 22 mmHg or greater than 36 mmHg after “washout” of medications, or in patients with prior glaucoma surgery of any type including argon laser trabeculoplasty,
for implantation of more than a single stent, after complications during cataract surgery, and when implantation has been without concomitant cataract surgery with IOL
implantation for visually significant cataract. ADVERSE EVENTS. The most common post-operative adverse events reported in the randomized pivotal trial included early postoperative corneal edema (8%), BCVA loss of * 1 line at or after the 3-month visit (7%), posterior capsular opacification (6%), stent obstruction (4%) early post-operative anterior
chamber cells (3%), and early post-operative corneal abrasion (3%). Please refer to Directions for Use for additional adverse event information. CAUTION: Federal law restricts
this device to sale by, or on the order of, a physician. Please reference the Directions for Use labeling for a complete list of contraindications, warnings, precautions, and adverse
events. ©2015 Glaukos Corporation. Glaukos and iStent are registered trademarks of Glaukos Corporation.
10
surgery
Survey: More surgeons using primary
vitrectomy, microincision technology
Retinal surgeons around the world making shift to easier, less-invasive procedures, data show
By Cheryl Guttman Krader; Reviewed by Maria H. Berrocal, MD
SAN JUAN, PUER TO RICO::
esults of surveys conducted by
the American Society of Retina
Specialists (ASRS) show there
are some international differences in surgeon preferences
for retinal detachment repair
techniques.
Globally, however, the data from those
surveys and other sources indicate increased
utilization of vitrectomy, growing popularity
of microincisional (23- and 25-gauge) procedures, greater movement into
ambulatory surgery centers,
and a declining role of general anesthesia.
“The increase in primary
vitrectomy is likely explained
by the fact that surgeons see
Dr. Berrocal
it as being easier and faster
than scleral buckle surgery,” said Maria H.
Berrocal, MD, assistant professor of ophthalmology, University of Puerto Rico School of
Medicine, San Juan. “In addition, as vitrectomy is used more often, there is less exposure
in training programs to learning the scleral
buckle procedure.
“The expanded role of 23- and 25-gauge
valved cannulas corresponds with appreciation for the benefit of microincisional sur-
R
Wide-angle viewing showing perfluorocarbon liquid injection to flatten retina in a giant retinal tear.
(Images courtesy of Maria H. Berrocal, MD)
‘As vitrectomy is used more
often, there is less exposure
in training programs to learning
the scleral buckle procedure.’
— Maria H. Berrocal, MD
gery in allowing faster procedures, but also
with the introduction of wide-angle viewing and better cutter technology,” Dr. Berrocal added.
TAKE-HOME
vitrectomy was the preferred proDR ILLING DOW N
cedure for about three-fourths
TO THE DETAILS
Surveys examining
of surgeons around the world,
According to recent data, vitretinal surgeonwith the exception of those in
rectomy accounts for more than
practice patterns for
Central and South America.
70% of procedures for rhegretinal detachment
For phakic eyes, U.S. surmatogenous retinal detachshow preferences
geons would be twice as likely
ment (RRD) in the United
differ regionally.
to perform vitrectomy comStates, Dr. Berrocal noted.
pared with scleral buckle surCompared with 1997, utiligery (48% versus 23%). Elsezation of vitrectomy is up
80%, while that of scleral buckle surgery where around the world, scleral buckle was
the leading choice, although the size of the
decreased by 70%.
Vitrectomy is also gap between it and vitrectomy varied in the
preferred by surgeons different regions.
U.S. surgeons also differed from their interoutside t he Un ited
States. However, when national colleagues in their likelihood to perit comes to other tech- form combined cataract and vitrectomy surniques, U.S. surgeons gery (41% versus 77%).
Data from U.S. surveys conducted in 2000 and
chose pneumatic retinopexy more often 2012 showed that surgeons grew more likely
than their colleagues to perform vitrectomy for eyes with floaters.
In 2012, 72% of U.S. surgeons as well as 65%
in other countries.
Data from the 2014 of surgeons internationally said they had perASRS Global Trends formed that procedure.
Regarding treatment for diabetic tractional
Survey show some
differences in surgeon preferences depend- detachment, the majority of surgeons around
the world indicated they would perform uring on the specific clinical scenario.
For pseudophakic retinal detachment without gent panretinal photocoagulation.
However, that procedure was more commonly
proliferative vitreoretinopathy (PVR), primary
Important Safety
Information
with known hypersensitivity to any
Contraindications
components of this product.
sILUVIEN is contraindicated in patients
Warnings and Precautions
with active or suspected ocular or
periocular infections including most
s)NTRAVITREALINJECTIONSHAVEBEEN
viral disease of the cornea and
associated with endophthalmitis, eye
conjunctiva including active epithelial
inflammation, increased intraocular
herpes simplex keratitis (dendritic
pressure, and retinal detachments.
keratitis), vaccinia, varicella, mycobacterial
Patients should be monitored following
infections and fungal diseases.
the intravitreal injection.
sUse of corticosteroids may produce
with glaucoma, who have cup to disc
posterior subcapsular cataracts,
ratios of greater than 0.8.
increased intraocular pressure,
glaucoma, and may enhance the
Please see brief summary of full Prescribing Information on following page.
INDICATION
ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for
the treatment of diabetic macular edema (DME) in patients who have been
previously treated with a course of corticosteroids and did not have a clinically
significant rise in intraocular pressure.
Make the move to ILUVIEN and provide sustained,
submicrogram levels of fluocinolone acetonide (FAc)
for 36 months from a single intravitreal implant.1
Primary month-24
endpoint met.
Significantly more
patients treated with
ILUVIEN achieved
≥15-letter
improvement
from baseline.1
The most common
adverse reactions
reported were cataract
development (ILUVIEN
82%; sham 50%)
and intraocular
pressure elevation of
>10 mmHg (ILUVIEN
34%; sham 10%).1
establishment of secondary ocular infections due
to bacteria, fungi, or viruses. Corticosteroids are
not recommended to be used in patients with a
history of ocular herpes simplex because of the
potential for reactivation of the viral infection.
s0ATIENTSINWHOMTHEposterior capsule of the lens
is absent or has a tear are at risk of implant
migration into the anterior chamber.
Adverse Reactions
sThe most common adverse reactions reported
were cataract development (ILUVIEN 82%; sham
50%) and intraocular pressure elevation of >10
mmHg (ILUVIEN 34%; sham 10%).
Nonbioerodable,
implant designed
to deliver
submicrogram
levels of steroid.1
Learn more at ILUVIEN.com
1.ILUVIEN® [package insert]. Alpharetta, GA: Alimera Sciences, Inc.; 2014.
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION
Table 1 (continued)
ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg For Intravitreal Injection
Adverse Reactions
ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the
treatment of diabetic macular edema in patients who have been previously treated
with a course of corticosteroids and did not have a clinically significant rise in
intraocular pressure.
Intravitreal Injection-related Effects: Intravitreal injections, including those with
ILUVIEN, have been associated with endophthalmitis, eye inflammation, increased
intraocular pressure, and retinal detachments. Patients should be monitored following
the intravitreal injection.
Steroid-related Effects: Use of corticosteroids including ILUVIEN may produce
posterior subcapsular cataracts, increased intraocular pressure and glaucoma. Use of
corticosteroids may enhance the establishment of secondary ocular infections due to
bacteria, fungi, or viruses.
Corticosteroids are not recommended to be used in patients with a history of ocular
herpes simplex because of the potential for reactivation of the viral infection.
Risk of Implant Migration: Patients in whom the posterior capsule of the lens is absent
or has a tear are at risk of implant migration into the anterior chamber.
ADVERSE REACTIONS
Clinical Studies 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 practice.
Adverse reactions associated with ophthalmic steroids including ILUVIEN include
cataract formation and subsequent cataract surgery, elevated intraocular pressure, which
may be associated with optic nerve damage, visual acuity and field defects, secondary
ocular infection from pathogens including herpes simplex, and perforation of the globe
where there is thinning of the cornea or sclera.
ILUVIEN was studied in two multicenter, randomized, sham-controlled, masked trials in
which patients with diabetic macular edema were treated with either ILUVIEN (n=375)
or sham (n=185). Table 1 summarizes safety data available when the last subject
completed the last 36-month follow up visit for the two primary ILUVIEN trials. In these
trials, subjects were eligible for retreatment no earlier than 12 months after study entry.
Over the three-year follow up period, approximately 75% of the ILUVIEN treated subjects
received only one ILUVIEN implant.
Table 1: Ocular Adverse Reactions Reported by ≥1% of Patients and Non-ocular
Adverse Reactions Reported by ≥5% of Patients
Adverse Reactions
ILUVIEN (N=375)
n (%)
Sham (N=185)
n (%)
Ocular
Cataract1
192/2352 (82%)
61/1212 (50%)
Myodesopsia
80 (21%)
17 (9%)
Eye pain
57 (15%)
25 (14%)
Conjunctival haemorrhage
50 (13%)
21 (11%)
Posterior capsule opacification
35 (9%)
6 (3%)
Eye irritation
30 (8%)
11 (6%)
Vitreous detachment
26 (7%)
12 (7%)
Conjunctivitis
14 (4%)
5 (3%)
Corneal oedema
13 (4%)
3 (2%)
Foreign body sensation in eyes
12 (3%)
4 (2%)
Eye pruritus
10 (3%)
3 (2%)
Ocular hyperaemia
10 (3%)
3 (2%)
Optic atrophy
9 (2%)
2 (1%)
Ocular discomfort
8 (2%)
1 (1%)
Photophobia
7 (2%)
2 (1%)
Retinal exudates
7 (2%)
0 (0%)
Anterior chamber cell
6 (2%)
1 (1%)
Eye discharge
6 (2%)
1 (1%)
US-ILV-MMM-0034-02 02/15
Non-ocular
Anemia
Headache
Renal failure
Pneumonia
40 (11%)
33 (9%)
32 (9%)
28 (7%)
Sham (N=185)
n (%)
10 (5%)
11 (6%)
10 (5%)
8 (4%)
1
Includes cataract, cataract nuclear, cataract subcapsular, cataract cortical and cataract diabetic in
patients who were phakic at baseline. Among these patients, 80% of ILUVIEN subjects vs. 27% of
sham-controlled subjects underwent cataract surgery.
2
235 of the 375 ILUVIEN subjects were phakic at baseline; 121 of 185 sham-controlled subjects
were phakic at baseline.
Increased Intraocular Pressure
Table 2: Summary of Elevated IOP-Related Adverse Reactions
Event
ILUVIEN (N=375)
n (%)
Non-ocular
IOP elevation ≥ 10 mm Hg from baseline
IOP elevation ≥ 30 mm Hg
Any IOP-lowering medication
Any surgical intervention for elevated
intraocular pressure
Sham (N=185)
n (%)
127 (34%)
75 (20%)
144 (38%)
18 (10%)
8 (4%)
26 (14%)
18 (5%)
1 (1%)
25
Mean Intraocular Pressure (mm Hg)
CONTRAINDICATIONS
Ocular or Periocular Infections: ILUVIEN is contraindicated in patients with active
or suspected ocular or periocular infections including most viral disease of the cornea
and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis),
vaccinia, varicella, mycobacterial infections and fungal diseases.
Glaucoma: ILUVIEN is contraindicated in patients with glaucoma, who have cup to disc
ratios of greater than 0.8.
Hypersensitivity: ILUVIEN is contraindicated in patients with known hypersensitivity to
any components of this product.
ILUVIEN (N=375)
n (%)
20
15
10
5
0
0
6
12
18
Month
ILUVIEN (N=375)
24
30
36
Sham (N=185)
Figure 1: Mean IOP during the study
Cataracts and Cataract Surgery
At baseline, 235 of the 375 ILUVIEN subjects were phakic; 121 of 185 sham-controlled
subjects were phakic. The incidence of cataract development in patients who had a phakic
study eye was higher in the ILUVIEN group (82%) compared with sham (50%). The median
time of cataract being reported as an adverse event was approximately 12 months in the
ILUVIEN group and 19 months in the sham group. Among these patients, 80% of ILUVIEN
subjects vs. 27% of sham-controlled subjects underwent cataract surgery, generally within
the first 18 months (Median Month 15 for both ILUVIEN group and for sham) of the studies.
Postmarketing Experience: The following reactions have been identified during postmarketing use of ILUVIEN in clinical practice. Because they are reported voluntarily,
estimates of frequency cannot be made. The reactions, which have been chosen for
inclusion due to either their seriousness, frequency of reporting, possible causal connection
to ILUVIEN, or a combination of these factors, include reports of drug administration error
and reports of the drug being ineffective.
Pregnancy: Pregnancy Category C.
There are no adequate and well-controlled studies of ILUVIEN in pregnant women. Animal
reproduction studies have not been conducted with fluocinolone acetonide. Corticosteroids
have been shown to be teratogenic in laboratory animals when administered systemically at
relatively low dosage levels. ILUVIEN should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Nursing Mothers: Systemically administered corticosteroids are present in human milk
and could suppress growth and interfere with endogenous corticosteroid production. The
systemic concentration of fluocinolone acetonide following intravitreal treatment with
ILUVIEN is low. It is not known whether intravitreal treatment with ILUVIEN could result
in sufficient systemic absorption to produce detectable quantities in human milk. Exercise
caution when ILUVIEN is administered to a nursing woman.
Pediatric Use: Safety and effectiveness of ILUVIEN in pediatric patients have not
been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed
between elderly and younger patients.
Manufactured for:
"MJNFSB4DJFODFT*ODt8JOEXBSE1BSLXBZ
"MQIBSFUUB("t1BUFOUFE4FFXXXBMJNFSBTDJFODFTDPN
All Rights Reserved; Issue Date September 2014;
ILUVIEN is a registered trademark of Alimera Sciences, Inc.
surgery
MANAGING GIANT RETINAL TEAR
VIDEO To watch a 23-gauge vitrectomy
with 25-gauge chandelier to manage a phakic
giant retinal tear, go to http://bit.ly/1GojNwt
MORE VIDEOS:
Go to http://bit.ly/1D1mtT9
Go to http://bit.ly/1MpeDCr
(Videos courtesy of Maria H. Berrocal, MD)
ENDOTHELIUM
have shorter chains, coat the endothelium
well, and are more difficult to remove.
> Cohesives, such as Healon and Healon 5
(AMO), Provisc (Alcon), and Amvisc (Bausch
+ Lomb) that have longer chains, are easy to
remove, and facilitate optimal visualization in
the eye.
> Adaptives, such as Healon 5 and DiscoVisc (Alcon) that are cohesive under lowflow conditions and dispersive in high-flow
conditions.
IRR IGATION AND
ASPIR ATION
The importance of removing all nuclear fragments cannot be overemphasized, Dr. Kim
said. He recounted a retrospective case series from the Duke Eye Center that included
54 eyes of 54 patients with lens fragments
after cataract surgery identified by slit lamp
evaluation, gonioscopy, and ultrasound biomicroscopy. All lens fragments were found
in the inferior angle and 80% of patients
with corneal edema were diagnosed with
a lens fragment after day 1 postoperatively.
Importantly, three of five patients who had
chosen by U.S. surgeons than their international colleagues (76% versus 64%), whereas
the international surgeons were more likely
than U.S. surgeons to perform vitrectomy alone
or closely following anti-vascular endothelial
growth factor (VEGF) injection.
Anti-VEGF injection alone would be used
by a minority of surgeons, but was considered
the initial choice more often by those in the
United States than elsewhere.
While data for the years 2006, 2011, and
2014 showed a global trend to smaller gauge
vitrectomy surgery, in 2014, 25-gauge instrumentation predominated over 23-gauge among
U.S. surgeons (52% versus 44%), whereas 23gauge was being used more often elsewhere
around the world.
U.S. surgeons also were more likely than
their international colleagues to use valved
trocars during surgery (69% versus 18% to
40%).
In addition, survey data revealed regional
11
differences in the preferred dye for staining
the internal limiting membrane. Indocyanine
green was the leading choice in the United
States (70%) and brilliant blue elsewhere (58%
to 80%).
“That difference probably is explained by
availability,” Dr. Berrocal said.
Perfluorocarbon liquids in vitrectomy for
routine primary RRD without PVR were being
used overwhelmingly more by surgeons outside the United States compared with the
Americans, whereas chandelier and lighted
lasers were being used mostly in the United
States. ■
MARIA H. BERROCAL, MD
E: mariahberrocal@hotmail.com
This article was adapted from a presentation by Dr. Berrocal at the 2014 meeting of
the American Academy of Ophthalmology. Dr. Berrocal is a consultant to and receives
lecture fees from Alcon Laboratories and is a consultant to Alimera and Hemera.
TAKE-HOME
traoperative administration
that has received FDA apFive pearls should be
proval. The solution conconsidered to protect the
tains phenylephrine hydroendothelium after
chloride 1% and ketorolac
cataract surgery. These
tromethamine 0.3% and no
IN TR AC A MER A L ,
involve consideration of
preservatives or bisulfites.
POSTOPER ATIVE
the phacoemulsification
The product does not need
DRUGS
techniques and
to be mixed or the dilution
Toxic anterior segment syntechnology, use of
calculated; one vial is indrome (TASS) is a devastatviscoelastics, irrigation
jected into 500 milliliters
ing, albeit rare, complication
and aspiration techniques,
of balanced saline irrigatafter cataract surgery, Dr. Kim
intracameral medications,
ing solution.
continued.
and postoperative
Medical therapy after catTASS—which typically
medications.
aract surgery includes inbegins 12 to 48 hours folstillation of corticosteroids
lowing cataract or anterior
prednisolone acetate 1% and
segment surgery—is a clinidifluprednate 0.05%, newer
cally relative, sterile postoperative inflammatory reaction caused by delivery systems via nanoparticles and punca noninfectious substance that enters the tal plugs, and future medications such as Rhoanterior segment and causes toxic damage kinase inhibitors, Dr. Kim said. ■
to the intraocular tissues. The syndrome improves after treatment with corticosteroids.
While irrigating solutions or ophthalmic
viscoelastic devices and ophthalmic instrument contaminants are culprits in TASS, ocular medications also have been implicated.
Incorrect concentrations, pH, or osmolality; a
vehicle with incorrect pH or osmolality; and
TERRY KIM, MD
preservatives in a medication solution have
E: terry.kim@duke.edu
been identified as causes.
Dr. Kim is a consultant to Alcon Laboratories, Bausch + Lomb, Ivantis, Kala
Omidria (Omeros Corp.) is a new clear,
Pharmaceuticals, Ocular Systems Inc., Ocular Therapeutix, Omerus, PowerVision, Shire,
colorless, sterile solution concentrate for inand TearScience.
corneal edema that did not
resolve after lens extraction
required DSEK to treat corneal decompensation.
12
surgery
What surgeons need to discuss when
introducing MIGS with patients
Some solid advice to avoid risk of bias in glaucoma treatment recommendations
By Vanessa Caceres; Reviewed by George L. Spaeth, MD
PHIL ADEL PHIA ::
OPHTHALMIC SURGEONS introduc-
MIGS because it is newer and works better.
However, that is deceiving.
“A lie is not an untruth,” he said. “It’s wrong
to lie to patients, and it removes the ability to
make an informed decision. You can say that
new surgeries work better than old ones, but
if that’s used to entice a patient to do a new
procedure, it’s a lie.”
ing microinvasive glaucoma surgery (MIGS)
for the first time to patients will want to think
carefully about how they describe the procedure and present treatment options to patients,
said George L. Spaeth, MD.
“We have a responsibility to enhance our
patients’ ability to care for themselves,” said
Dr. Spaeth, Esposito Research Professor, Wills
DECEIVING WORDS
Eye Hospital/Thomas Jefferson Medical Col- Dr. Spaeth also pointed out common wordlege, Philadelphia. “We need to help them more ing used by physicians that can be deceivthan harm, and we need to be fair.”
ing. For example, saying “We expect” is
Patients need to make decisions about their more deceptive than “We hope.” Using the
care that is appropriately accurate. However, word “safe” is not as cautious as saying “admost often, patients make a decision based on equately safe.”
the way that the physician presents treatment
“Every time we use the word ‘safe,’ we have
options, he said.
to be aware that nothing we do is safe,” he said.
“Our recommendations are rarely challenged,” “It may be adequately safe, but it’s not safe.”
Dr. Spaeth said. “Patients are reluctant to say
There are also problems with saying somethat they don’t understand something. We’re thing has been studied or is recommended,
really making that decision.”
Dr. Spaeth said.
Specific to glaucoma, Dr. Spaeth focused on
“Just because something has been studied
how the zeal for a new type of
doesn’t mean it’s proven,” he
surgery may steer patients spesaid. “Just because something
cifically to MIGS and reveal a
is recommended doesn’t mean
surgeon’s bias.
it’s widely accepted. And someWhen microinvasive
thing may be less invasive, but
glaucoma surgery is
H ELP T H E PAT IE N T
perhaps it’s also less effective.”
a potential treatment
The first goal of any physician
Dr. Spaeth said that physioption, surgeons
is to help the patient, he said.
cians are capable of bias in their
should present it as
“We hear frequently, ‘First,
desire for more effective glauneutrally as possible.
do no harm.’ That’s not a good
coma surgeries.
principle,” Dr. Spaeth said. “We
“Those who are passionate
don’t want to harm, but that’s not our first about finding a better glaucoma procedure are
goal. Our first goal is to help. Every treatment the ones who must be distrusted because they
involves some harm.”
have the greatest propensity to be biased,” he
Dr. Spaeth gave the example of telling a pa- said.
tient he or she has a narrow angle. The physician may worry about upsetting a patient
L A NGUAGE TO USE
with this news.
To keep a surgeon’s language more neutral,
“But by not telling them, it is harmful, as Dr. Spaeth shared an example of what to say
that deprives them of making a decision about when presenting glaucoma treatment options:
appropriate care,” he said.
“I’m going to recommend a ____________ beDr. Spaeth explained that the wording used cause for you, my opinion is that the balance
by surgeons to describe a procedure can be of risk and benefits favors this. The procedure
misleading. Some surgeons may intentionally or is still under development. If it works as well
unintentionally bias patients to want to choose as we hope, it will benefit not only you, but
TAKE-HOME
Neutral Language
is Best
Here is an example of what physicians should say when presenting
glaucoma treatment options:
“I’m going to recommend a __________
because for you, my opinion is that the
balance of risk and benefits favors this.
The procedure is still under development.
If it works as well as we hope, it will
benefit not only you, but others as well.
However, you must understand that longterm effects are not known, whereas we
do know that __________ worked well in
most people like you.”
others as well. However, you must understand
that long-term effects are not known, whereas
we do know that __________ worked well in
most people like you.”
If the patient is taking part in a MIGS-related
study, the surgeon can go on to explain he or
she would have to do some things beyond the
usual preoperative or postoperative surgical
care, such as taking part in extra tests or returning for extra visits.
“If we are disappointed because the patient
chooses not to have the MIGS, we know we
are improperly biased,” Dr. Spaeth said. “We
have an ethical responsibility to develop better treatments, but not for our benefit. The
procedure is for the benefit of the patient.” ■
GEORGE L. SPAETH, MD
E: georgespaeth@aol.com
This article was adapted from Dr. Spaeth’s presentation during Glaucoma Subspecialty
Day at the 2014 meeting of the American Academy of Ophthalmology. He did not
indicate any proprietary interest in the subject matter.
14
surgery
Single-port PPV allows safe phaco
in crowded anterior chamber
Outcomes from a series of 54 eyes support the efficacy and safety of the technique
By Cheryl Guttman Krader; Reviewed by R.J. Mackool Jr., MD
AS TORIA, N Y ::
ne-port pars plana vitrectomy (PPV) is the only effective technique to deepen
the anterior chamber when
performing phacoemulsification in crowded eyes, according to R.J. Mackool Jr., MD.
Dr. Mackool Jr. reported the experience of
two surgeons (Richard Mackool Sr., MD, and
Dr. RJ Mackool Jr.) with single-port pars plana
vitrectomy in a series of 54 eyes of 41 patients.
Cases from the series were performed between
2010 and 2012 with a follow-up ranging from
4 months to 4 years.
The rate of zonular laxity in the series proved
extremely high at 54%, and 5% of the eyes
had no zonular support, requiring implantation of an anterior chamber IOL (ACLs were
chosen given advanced patient age). The only
complication in the series was one case of cystoid macular edema which resolved with topical steroid.
O
SPACE N EEDED
“Surgeons must assess chamber depth on the
operating room table to determine if phaco can
be performed without damaging the endothelium,” said Dr. Mackool Jr., assistant director
of the Mackool Eye Institute and Laser Center
in Astoria, NY. “The space needed will vary,
depending on the density of the lens and the
surgeon’s phaco technique.
“If there is any doubt about adequate chamber depth, the surgeon should err on the side
of safety by performing a one-port PPV,” Dr.
Mackool Jr. said.
PERFOR MING ONE-PORT PPV
Dr. Mackool Sr. has been performing and teaching the one-port PPV technique since the early
1980s and David Chang, MD, published his experience with pars plana vitrectomy to deepen
the anterior chamber in 2001.
A one-port PPV is performed by creating
a pars plana wound 3.5 mm posterior to the
limbus with the gauge of choice (Drs. Mackool
tend to use a 23-gauge vitrector). The vitrector
is advanced into the posterior segment in the
direction of the optic nerve until the tip is visible. Vitreous is removed until the eye is soft
by digital palpation and the anterior chamber
is filled with viscoelastic.
“Vitrectomy should not be performed with
infusion since aqueous misdirection can occur
with no increase in chamber depth, leaving
the surgeon wondering whether the chamber
is still shallow due to a choroidal hemorrhage
or infusion misdirection,” Dr. Mackool Jr. said.
He noted that visibility may be limited due
to cataract density. In these cases the surgeon
should score the vitrector 10 to 12 mm from
the tip as a guide to proper insertion depth.
“The vitrector is advanced toward the optic
nerve until the mark is at the pars plana incision and the vitrectomy is performed,” he said.
SINGLE-PORT PPV
VIDEO Watch the one-port pars plana
vitrectomy (PPV) technique being performed.
Go to http://bit.ly/1L1WrDk
(Video courtesy of R.J. Mackool Jr., MD)
Dr. Mackool Jr. noted that intravenous administration of mannitol has been described as
a strategy for deepening the anterior chamber.
However, he said that mannitol can have
untoward systemic effects and does not sufficiently deepen the anterior chamber. ■
R.J. MACKOOL JR., MD
E: richardmackool@aol.com
This article was adapted from a presentation by Dr. Mackool Jr. at the 2014 meeting
of the American Academy of Ophthalmology. Dr. Mackool Jr. is a speaker for Alcon
Laboratories.
Three firms up to ‘Vision4Mars’ Challenge
HOUS TON ::
THE NATIONAL Space Biomedical Research Institute (NSBRI) Industry Forum—as
part of its “Vision4Mars” Challenge to identify
and advance critical medical technologies for
ocular health—has selected and funded three
companies to further develop unique technologies that address visual problems in space, as
well as on earth.
These companies are Annidis Inc. of Grandville, MI, which has developed the Annidis
RHA ophthalmoscope; Equinox, LLC of Sioux
Falls, SD, founded by John Berdahl, MD, who
is developing the Balance Goggles; and Web
Vision Centers Group, LLC of South Jordan, UT,
led by Bob Main, who will work with several
vision lens companies to customize adjustable
prescription glasses for spaceflight. ■
SYMPTOMATIC VITREOMACULAR
ADHESION (VMA)
SYMPTOMATIC VMA MAY LEAD TO VISUAL IMPAIRMENT FOR YOUR PATIENTS1-3
IDENTIFY
REFER
Recognize metamorphopsia as a key sign of symptomatic VMA
and utilize OCT scans to confirm vitreomacular traction.
Because symptomatic VMA is a progressive condition that may lead
to a loss of vision, your partnering retina specialist can determine
if treatment is necessary.1-3
THE STEPS YOU TAKE TODAY MAY MAKE A DIFFERENCE
FOR YOUR PATIENTS TOMORROW
© 2014 ThromboGenics, Inc. All rights reserved. ThromboGenics, Inc., 101 Wood Avenue South, Suite 610, Iselin, NJ 08830 – USA. THROMBOGENICS and the THROMBOGENICS logo are trademarks or registered trademarks of
ThromboGenics NV. 9/14 OCRVMA0220
References: 1. Sonmez K, Capone A, Trese M, et al. Vitreomacular traction syndrome: impact of anatomical configuration on anatomical and visual outcomes. Retina. 2008;28:1207-1214. 2. Hikichi T, Yoshida A,
Trempe CL. Course of vitreomacular traction syndrome. Am J Ophthalmol. 1995;119(1):55-56. 3. Stalmans P, Lescrauwaet B, Blot K. A retrospective cohort study in patients with diseases of the vitreomacular interface (ReCoVit).
Poster presented at: The Association for Research in Vision and Ophthalmology (ARVO) 2014 Annual Meeting; May 4-8, 2014; Orlando, Florida.
16
LATEST CLINICAL PERSPECTIVES IN
Special Report )
REFRACTIVE SURGERY
ADVANCES CONTINUE TO PROGRESS FOR TREATMENT OF REFRACTIVE IRREGULARITIES
Comparing Treatment Approaches
STANDARD 9 MM
CONE-LOCALIZED
EPITHELIUM-ON CXL:
NEW FRONTIER FOR
TOPOGRAPHIC ABNORMALITIES
Procedure may ultimately make customized treatment more
attractive for therapeutic, refractive indications
By Lynda Charters; Reviewed by William J. Dupps Jr., MD, PhD
T
CL E VEL AND ::
take-home
The rationale for
epithelium-on crosslinking
procedures is strong,
and may ultimately make
customized treatment of
topographic abnormalities
more attractive for
therapeutic and refractive
indications.
hough epithelium-on corneal
collagen crosslinking (CXL) is
emerging as a possible alternative to epithelium-off CXL,
a number of important questions remain unanswered.
While the major advantages include less pain and reduced risk
of microbial and sterile keratitis, the various techniques have not
been directly compared with the epithelium-off gold standard in
Topographic maps from finite element model
simulations of crosslinking in a keratoconus patient
demonstrate greater shape-normalizing effects with
a customized treatment pattern (right) than with a
standard 9-mm treatment (left). Dioptric difference
maps illustrating predicted treatment effect are shown
in the lower row. (Images courtesy of Willliam J. Dupps Jr., MD, PhD)
clinical trials. The safety rationale for performing epithelium-on CXL is strong, according to
William J. Dupps Jr., MD, PhD.
“Most of the post-treatment symptoms and
complications that we see with
CXL are associated with epithelial debridement and the
ongoing presence of an epithelial defect,” said Dr. Dupps,
staff, Ophthalmology, Biomedical Engineering and TransDr. Dupps
plantation, Cole Eye Institute,
Cleveland Clinic, Cleveland.
These complications include delayed epithelial healing, sterile keratitis, microbial keratitis, central stromal scarring, and potential
loss of best-corrected visual acuity.
PENETR ATION
The effectiveness of epithelium-on CXL is the
primary concern. Riboflavin, ultraviolet light,
and oxygen are the essential components of
the effectiveness of epithelial-on CXL, but an
intact epithelium inhibits their penetration,
Dr. Dupps noted.
However, the epithelial-off CXL procedure—
considered the most effective approach—demonstrated a failure rate of about 8% in one
long-term study because of continued disease
progression.
“We expect that the failure rate will be higher
for transepithelial CXL approaches if they are
less effective in stiffening the cornea,” he said.
“Is this an acceptable compromise?”
The goals of treatment, the rate of disease
progression, and the impact of complications
will likely lead to unique answers for each patient, Dr. Dupps said.
DEFINING EFFECTIVENESS
“Exciting” techniques are emerging to measure CXL’s efficacy, according to Dr. Dupps.
One—Brillouin spectroscopy—was used to
demonstrate increases in regional corneal stiffness after an epithelial-off procedure, as reported by Scarcelli and colleagues (Invest Ophthalmol Vis Sci. 2013;54:1418-1425).
Another emerging technique is optical coherence tomography (OCT) elastography, which Dr.
Continues on page 19 : Epi-on CXL
LUMIGAN 0.01%
(bimatoprost ophthalmic solution)
®
At doses at least 41 times the maximum intended human exposure based on blood
AUC levels, the gestation length was reduced in the dams, the incidence of dead
fetuses, late resorptions, peri- and postnatal pup mortality was increased, and pup
body weights were reduced.
There are no adequate and well-controlled studies of LUMIGAN® (bimatoprost
ophthalmic solution) 0.01% administration in pregnant women. Because animal
Brief Summary—Please see the LUMIGAN® 0.01% package insert for full
reproductive studies are not always predictive of human response LUMIGAN® 0.01%
Prescribing Information.
should be administered during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
LUMIGAN® (bimatoprost ophthalmic solution) 0.01% is indicated for the reduction
Nursing Mothers: It is not known whether LUMIGAN® 0.01% is excreted in human
of elevated intraocular pressure in patients with open angle glaucoma or
milk, although in animal studies, bimatoprost has been shown to be excreted in
ocular hypertension.
breast milk. Because many drugs are excreted in human milk, caution should be
CONTRAINDICATIONS
exercised when LUMIGAN® 0.01% is administered to a nursing woman.
None
Pediatric Use: Use in pediatric patients below the age of 16 years is not recommended
because of potential safety concerns related to increased pigmentation following
long-term chronic use.
Pigmentation: Bimatoprost ophthalmic solution has been reported to cause changes
to pigmented tissues. The most frequently reported changes have been increased Geriatric Use: No overall clinical differences in safety or effectiveness have been
pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is observed between elderly and other adult patients.
expected to increase as long as bimatoprost is administered. The pigmentation Hepatic Impairment: In patients with a history of liver disease or abnormal ALT,
change is due to increased melanin content in the melanocytes rather than to AST and/or bilirubin at baseline, bimatoprost 0.03% had no adverse effect on liver
an increase in the number of melanocytes. After discontinuation of bimatoprost, function over 48 months.
pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital OVERDOSAGE
tissue and eyelash changes have been reported to be reversible in some patients. No information is available on overdosage in humans. If overdose with LUMIGAN®
Patients who receive treatment should be informed of the possibility of increased (bimatoprost ophthalmic solution) 0.01% occurs, treatment should be symptomatic.
pigmentation. The long term effects of increased pigmentation are not known.
In oral (by gavage) mouse and rat studies, doses up to 100 mg/kg/day did not
Iris color change may not be noticeable for several months to years. Typically, the produce any toxicity. This dose expressed as mg/m2 is at least 210 times higher than
brown pigmentation around the pupil spreads concentrically towards the periphery the accidental dose of one bottle of LUMIGAN® 0.01% for a 10 kg child.
of the iris and the entire iris or parts of the iris become more brownish. Neither nevi
nor freckles of the iris appear to be affected by treatment. While treatment with NONCLINICAL TOXICOLOGY
LUMIGAN® (bimatoprost ophthalmic solution) 0.01% can be continued in patients Carcinogenesis, Mutagenesis, Impairment of Fertility: Bimatoprost was not
who develop noticeably increased iris pigmentation, these patients should be carcinogenic in either mice or rats when administered by oral gavage at doses
of up to 2 mg/kg/day and 1 mg/kg/day respectively (at least 192 and 291 times
examined regularly [see Patient Counseling Information (17.1)].]
Eyelash Changes: LUMIGAN® 0.01% may gradually change eyelashes and vellus the recommended human exposure based on blood AUC levels respectively) for
hair in the treated eye. These changes include increased length, thickness, and 104 weeks.
number of lashes. Eyelash changes are usually reversible upon discontinuation Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse
lymphoma test, or in the in vivoo mouse micronucleus tests.
of treatment.
Intraocular Inflammation: Prostaglandin analogs, including bimatoprost, have been Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day
reported to cause intraocular inflammation. In addition, because these products may (at least 103 times the recommended human exposure based on blood AUC levels).
exacerbate inflammation, caution should be used in patients with active intraocular PATIENT COUNSELING INFORMATION
inflammation (e.g., uveitis).
Potential for Pigmentation: Advise patients about the potential for increased brown
Macular Edema: Macular edema, including cystoid macular edema, has been pigmentation of the iris, which may be permanent. Also inform patients about the
reported during treatment with bimatoprost ophthalmic solution. LUMIGAN® 0.01% possibility of eyelid skin darkening, which may be reversible after discontinuation of
should be used with caution in aphakic patients, in pseudophakic patients with a LUMIGAN® (bimatoprost ophthalmic solution) 0.01%.
torn posterior lens capsule, or in patients with known risk factors for macular edema.
Potential for Eyelash Changes: Inform patients of the possibility of eyelash and
Bacterial Keratitis: There have been reports of bacterial keratitis associated with vellus hair changes in the treated eye during treatment with LUMIGAN® 0.01%.
the use of multiple-dose containers of topical ophthalmic products. These containers These changes may result in a disparity between eyes in length, thickness,
had been inadvertently contaminated by patients who, in most cases, had a pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash
concurrent corneal disease or a disruption of the ocular epithelial surface [see Patient growth. Eyelash changes are usually reversible upon discontinuation of treatment.
Counseling Information (17.3)].]
Handling the Container: Instruct patients to avoid allowing the tip of the dispensing
Use with Contact Lenses: Contact lenses should be removed prior to instillation of container to contact the eye, surrounding structures, fingers, or any other surface in
LUMIGAN® 0.01% and may be reinserted 15 minutes following its administration.
order to avoid contamination of the solution by common bacteria known to cause
ocular infections. Serious damage to the eye and subsequent loss of vision may
ADVERSE REACTIONS
Clinical Studies Experience: Because clinical studies are conducted under widely result from using contaminated solutions.
varying conditions, adverse reaction rates observed in the clinical studies of a drug When to Seek Physician Advice: Advise patients that if they develop an intercurrent
cannot be directly compared to rates in the clinical studies of another drug and may ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular
reactions, particularly conjunctivitis and eyelid reactions, they should immediately
not reflect the rates observed in practice.
®
In a 12-month clinical study with bimatoprost ophthalmic solutions 0.01%, the most seek their physician’s advice concerning the continued use of LUMIGAN 0.01%.
®
common adverse reaction was conjunctival hyperemia (31%). Approximately 1.6% Use with Contact Lenses: Advise patients that LUMIGAN 0.01% contains
of patients discontinued therapy due to conjunctival hyperemia. Other adverse drug benzalkonium chloride, which may be absorbed by soft contact lenses. Contact
reactions (reported in 1 to 4% of patients) with LUMIGAN® 0.01% in this study lenses should be removed prior to instillation of LUMIGAN® 0.01% and may be
included conjunctival edema, conjunctival hemorrhage, eye irritation, eye pain, eye reinserted 15 minutes following its administration.
pruritus, erythema of eyelid, eyelids pruritus, growth of eyelashes, hypertrichosis, Use with Other Ophthalmic Drugs: Advise patients that if more than one topical
instillation site irritation, punctate keratitis, skin hyperpigmentation, vision blurred, ophthalmic drug is being used, the drugs should be administered at least five (5)
and visual acuity reduced.
minutes between applications.
Postmarketing Experience: The following reaction has been identified during
®
postmarketing use of LUMIGAN 0.01% in clinical practice. Because it was reported
© 2014 Allergan, Inc., Irvine, CA 92612
voluntarily from a population of unknown size, estimates of frequency cannot be ®
marks owned by Allergan, Inc.
made. The reaction, which has been chosen for inclusion due to either its seriousness,
Patented. See: www.allergan.com/products/patent_notices
®
frequency of reporting, possible causal connection to LUMIGAN 0.01%, or a
Made in the U.S.A.
combination of these factors, includes headache.
APC87BO14 based on 71807US14.
Rx only
In postmarketing use with prostaglandin analogs, periorbital and lid changes including
deepening of the eyelid sulcus have been observed.
Pregnancy: Pregnancy Category C
Teratogenic effects: In embryo/fetal developmental studies in pregnant mice and
rats, abortion was observed at oral doses of bimatoprost which achieved at least 33
or 97 times, respectively, the maximum intended human exposure based on blood
AUC levels.
Special Report )
19
EPI-ON CXL
Dupps and colleagues are using in their laboratory, and which he explained can resolve spatial
stiffness properties. In a study using OCT elastography, they compared various transepithelial
and epithelium-off CXL techniques performed
in rabbit eyes (J Refract Surg. 2013;29:332-341).
After 3 months of follow-up, investigators
found the greatest corneal stiffening was found
in a group of rabbits treated with a transepithelial approach using benzalkonium chloride
and ethylene diamine-tetra-acetate as permeability enhancers, Dr. Dupps noted.
The results were replicated in a follow-up
experiment (Exp Eye Res. 2014;125:114-117).
“We think that this somewhat surprising result may be related to differences in the woundhealing response to CXL and the riboflavin
vehicle,” he said. “While the results should
not be directly extrapolated to human eyes,
the studies did demonstrate the potential for
certain transepithelial techniques to produce
stiffening effects on par with those of the epithelium-off standard.”
W H AT IS THE GOA L?
Is disease stabilization or topographic improvement the primary goal?
“Most would say that disease stabilization is
the goal, but CXL also has the potential to improve the corneal topography,” Dr. Dupps said.
Dr. Dupps and co-workers are using computational modeling techniques in their laboratory to gain a better understanding of how
the corneal shape and stiffness are related—
and how this relationship can be leveraged for
better outcomes.
He summarized their early work (Invest Ophthalmol Vis Sci. 2011;52:9174-9187) looking at the
differences in the corneal shape response when
the corneal properties were changed from weaker
to stiffer in simulated myopic LASIK procedures.
“A weaker cornea’s center displaces forward
and steepens slightly, leading to a myopic undercorrection,” Dr. Dupps said. “In contrast,
a stiffer cornea shows some central flattening and a relative overcorrection of myopia.”
These very different shape responses lead to
different refractive outcomes and are explained
purely by a difference in the corneal stiffness.
“Our conclusion was that the corneal biomechanical properties can be an important
driver of refractive outcomes,” Dr. Dupps said.
This relationship is even more important
in keratoconus.
“If we envision corneal ectasia as a disease
REFRACTIVE SURGERY
that is fundamentally a regional weakening
of the cornea, we can generate topographic
progression of the disease in a model, even
without thinning the cornea,” he said. “The
lower the corneal elastic modulus, the higher
the corneal curvature.”
However, this relationship between corneal strength and curvature is nonlinear, Dr.
Dupps said.
Investigators found that in the eye modeled
as part of their 2011 publication (Invest Ophthalmol Vis Sci.), the maximum K value in-
“This experiment provided a structural rationale for customizing the approach to CXL and
may be important in the debate about transepithelial CXL,” he said. “The stiffness of the cone
region relative to its surroundings is a major
driver of response; enhancing the stiffening
effect in the weakest area of the cornea relative to other areas will produce more ‘leverage’
for local flattening by also allowing favorable
compensatory steepening away from the cone.”
Building on this, Dr. Dupps explained that
existing evidence for a thinner epithelial cov-
‘The studies did demonstrate the potential for certain
transepithelial techniques to produce stiffening effects
on par with those of the epithelium-off standard.’
— William J. Dupps Jr., MD, PhD
creased modestly in response to decreases in
the corneal elastic modulus up to 30%, then
increased precipitously.
“Furthermore, every patient has a different corneal geometry, and therefore, a different tipping point regarding disease progression,” he said.
Dr. Dupps and his team are working to translate patient-specific simulation into a clinical
tool for predicting the risk of ectasia or its
progression.
“The hope is that at-risk patients can be
identified prior to procedures that would precipitate structural failure and steered instead
toward tissue-sparing and/or corneal stiffening procedures,” he said. “For patients who are
known to have keratoconus, disease progression simulations may be helpful in estimating
risk of progression and determining the optimal timing of CXL procedures.”
BEYOND STABILIZING
KER ATOCONUS
Another finding from the modeling studies
has important implications for patients who
have already lost vision due to topographic
disease progression.
“Focal collagen crosslinking has the potential
to produce greater reductions in cone steepness
than the pan-corneal treatments most patients
currently receive,” Dr. Dupps said.
In a modeling study of standard 9-mm treatment zones, Dr. Dupps observed the typical
1- to 2-D regional flattening effect. More focal
treatments with smaller diameters decentered
toward the cone much greater reductions in
cone steepness and marked reductions in coma.
Technologies are in the pipeline to allow spatial treatments and higher intensity treatments.
ering in the region of the cone could favor outcomes with epithelium-on CXL in some cases.
“If thinner epithelium favors greater crosslinking effect where it most needed and less
where it is not, the net curvature response
could still be very favorable even if absolute
stiffening effect is lower overall than epithelium-off CXL,” he said.
Transepithelial CXL techniques are attractive because of potential benefits related to less
postoperative pain, lower risk of sterile and
microbial keratitis, and faster visual recovery.
Questions about relative effectiveness require
more clinical investigation, and the results are
likely to depend on technique differences and
peculiarities of the epithelial thickness profile
seen in keratoconus.
A hybrid solution combining advantages of
epi-off and epi-on treatment could be a localized treatment with or without focal corneal
debridement that offers less corneal exposure
to ultraviolet light, a smaller epithelial defect,
and potentially greater topographic improvement, according to Dr. Dupps. ■
WILLIAM J. DUPPS JR., MD, PHD
E: bjdupps@sbcglobal.net
This article was adapted from Dr. Dupps’ presentation during Cornea Subspecialty
Day at the 2014 meeting of the American Academy of Ophthalmology. Dr. Dupps does
research for and is on the medical advisory board of Avedro. He is also founder of
OptoQuest, a Cleveland Clinic company with a commercial interest in computational
modeling of ocular surgery. Support for the work described above was provided by
Avedro, the National Institutes of Health (R01 EY02338), the National Keratoconus
Foundation/Discovery Eye Foundation, an Ohio Third Frontier Innovation Platform
Award to the Cleveland Clinic Cole Eye Institute, and an Unrestricted Grant and Career
Development Award from Research to Prevent Blindness.
FDA APPROVED
IS THE TIME TO PREVENT INTRAOPERATIVE MIOSIS
AND REDUCE POSTOPERATIVE OCULAR PAIN
OMIDRIA™ (phenylephrine and ketorolac injection) 1% / 0.3%
is the first and only FDA-approved treatment that both1:
Preemptively inhibits intraoperative miosis
Decreases postoperative ocular pain for 10 to 12 hours
OMIDRIA is preservative- and bisulfite-free
Easy to integrate into routine operating procedures
Add preoperatively to irrigation solution1
One 4-mL single-patient-use vial to 500 mL
Can be added to irrigation solution in the surgical suite
No other preparation required
OMIDRIA is added to ophthalmic irrigation solution used during
cataract surgery or intraocular lens replacement and is indicated
for maintaining pupil size by preventing intraoperative miosis and
reducing postoperative ocular pain.
CMS PASS-THROUGH STATUS EFFECTIVE JANUARY 1, 2015
OMIDRIA™ is reimbursed by CMS*
OMIDRIA has been granted transitional pass-through payment status under
the Medicare hospital outpatient prospective payment system (OPPS)
Pass-through status allows for payment for OMIDRIA separate from the bundled
Ambulatory Payment Classification (APC) payment for the surgical procedure
Contact 1-844-OMEROS1 (1-844-663-7671) for more information about
how to submit for OMIDRIA reimbursement.
IMPORTANT SAFETY INFORMATION
OMIDRIA must be added to irrigation solution prior to intraocular use.
OMIDRIA is contraindicated in patients with a known hypersensitivity to any
of its ingredients.
Systemic exposure of phenylephrine may cause elevations in blood pressure.
Use OMIDRIA with caution in individuals who have previously exhibited sensitivities
to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal
anti-inflammatories (NSAIDs), or have a past medical history of asthma.
The most commonly reported adverse reactions at 2-24% are eye irritation,
posterior capsule opacification, increased intraocular pressure, and anterior
chamber inflammation.
Use of OMIDRIA in children has not been established.
Please see the Full Prescribing Information for OMIDRIA
at www.omidria.com/prescribinginformation.
You are encouraged to report Suspected Adverse Reactions to
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*CMS=Centers for Medicare & Medicaid Services.
Reference: 1. OMIDRIA [package insert]. Seattle, WA: Omeros Corporation; 2014.
Omeros® and the Omeros logo® are registered trademarks, and Omidria™ and the Omidria logo™
are trademarks, of Omeros Corporation. © Omeros Corporation 2015, all rights reserved. 2015-022
22
Special Report )
REFRACTIVE SURGERY
(FIGURE 2)
Preoperative
topography is
suggestive of corneal
ectasia but the
patient did well with
a toric IOL. (Images
courtesy of Christopher E.
Starr, MD)
ABNORMAL CORNEAS
DRY EYE DISEASE
In Dr. Starr’s practice, dry eye is the most common etiology of abnormal corneas.
“Corneal staining, hyperosmolarity, and rapid tear film break-up time
can significantly affect topography and
keratometry calculations, creating IOL
errors,” he said.
“The pearl in patients with dry eye
is to treat aggressively preoperatively
(and) delay biometry and surgery until Dr. Starr
the ocular surface has normalized,” Dr. Starr
said. “This can sometimes take a long time.”
However, some patients with advanced cataracts may not want to wait for the cornea to
reach its optimal status and demand cataract
surgery despite significant dry eye disease. In
one such patient in his practice, implantation
of toric IOLs after cataract surgery resulted in
a plano refraction but substantial visual fluctuations during the day.
‘LU MP-A N D -BU MP ’
PAT HOLOGIE S
Epithelial basement membrane, Salzmann nodules, subepithelial fibrosis, and pterygia can
cause substantial irregular astigmatism, fluctuate, and recur after removal. However, the
big clinical decision associated with these is
“to scrape or not to scrape.”
“For patients with high expectations and
who want to reduce spectacle dependence, the
rule of thumb is to scrape, but well before
surgery,” Dr. Starr said. “Allow at least 6 to 8
weeks after superficial keratectomy or phototherapeutic keratectomy, repeat keratometry
and topography. After another 2 to 4 weeks,
repeat these measurements again. When the
cornea is stable and regular, a toric IOL can
be implanted.”
In certain scenarios, the best approach may
be not to scrape.
“In patients with stable mild peripheral lesions, regular astigmatism
in the central cornea, normal-sized
scotopic pupils, and good spectaclecorrected vision preoperatively, cataract surgery with implantation of a
toric IOL can be performed successfully without a superficial keratectomy,” he said.
Other tools—such as intraoperative aberrometry and light-adjustable IOLs—have
helped to improve refractive outcomes in
these patients.
Dr. Starr advised ruling out post-LASIK ectasia before implanting a toric IOL, with the
presumption that a high degree of corneal
astigmatism is present. He also recommended
preoperatively assessing candidacy for a possible laser vision correction touch-up in the
event of a refractive IOL “surprise.”
COR NEAL ECTASIAS
When facing patients with keratoconus, pellucid marginal corneal degeneration, postLASIK ectasia, post-keratoplasty (PK), and
post-deep anterior lamellar keratoplasty, the
rule of thumb is if patients can successful
wear a rigid gas permeable or scleral lens
PR EVIOUS LASER
postoperatively, a toric IOL should not be
VISION CORRECTION
implanted.
Many patients who have undergone LASIK,
However, a toric IOL is a consideration if
PRK, RK, or conductive keratoplasty
patients are contact lens-intolerare now developing cataracts and
ant, have acceptable spectacleare interested in premium IOL imcorrected vision, and have a fairly
plantation. The catch-22 is this is
regular central cornea over the
arguably the most-motivated patient
long term as in older patients or
Premium IOLs can
population for spectacle-indepen- be used successfully in
after a crosslinking procedure.
dence, and yet, their IOL calcula- patients with corneal
A toric IOL is also a reasonable
tions are the most unpredictable, pathologies.
choice in post-PK eyes in which
according to Dr. Starr.
there is a low risk of graft fail“The ASCRS [American Society of Cataract ure and the need for another PK, Dr. Starr
and Refractive Surgery] Post-Refractive IOL explained.
Calculator is a godsend for these patients,”
he said. “Over time, it has become more and
FUCHS’ ENDOTHELIAL
more accurate, and the range of IOL suggesDY SF U NC T ION
tions are much tighter now. I am much more In patients with mild guttata, but no morning
comfortable now targeting plano than pre- blur or Descemet’s folds and a central corneal
viously when I would target some myopia.” thickness of 630 μm or less, cataract surgery
take-home
Special Report )
23
REFRACTIVE SURGERY
can be performed with or without implantation of a toric IOL, Dr. Starr advised.
The rule of thumb in these patients is that
all posterior lamellar grafts cause hyperopic
shifts. In Descemet’s stripping automated endothelial keratoplasty (DSAEK), –1 to –1.5 D is
typically targeted. In Descemet membrane endothelial keratoplasty, –0.25 to –0.5 D should
be targeted, according to Dr. Starr.
“My preference in DSAEK is a 90-μm thick
graft, and my IOL target is about –1 D,” he said.
“Premium IOLs can be used successfully in
patients with abnormal corneas,” Dr. Starr said.
“For the best refractive outcomes, adjunctive
procedures are often needed before, during,
and sometimes after cataract surgery, which
can delay surgery and/or the time needed
to achieve a satisfactory uncorrected visual
acuity.” ■
(FIGURE 3) Salzmann’s
nodules can cause
irregular astigmatism
and keratometric
instability in cataract
surgery patients. (Image
courtesy of Christopher E.
Starr, MD)
CHRISTOPHER E. STARR, MD
E: cestarr@med.cornell.edu
This article was adapted from Dr. Starr’s presentation during Cornea Subspecialty Day
at the 2014 meeting of the American Academy of Ophthalmology. Dr. Starr has no
financial interest in any aspect of this report.
Poll: Patients in favor of video visits
By Rose Schneider; Content Specialist, Ophthalmology Times
A MAJORITY OF Americans say they
would be willing to use videos for their physician visit, according to a Harris Poll survey.
Of the 64% of patients who said they would
visit their doctor via video, 61% said convenience was a deciding factor.
Telehealth company American Well commissioned the online poll, which surveyed 2,019
adults aged 18 years and older.
“The rise of mobile health and medicine has
allowed patients to access medical care easily,”
said Richard Awdeh, MD, director, technology
transfer, and assistant professor, ophthalmology, Bascom Palmer Eye Institute, University
of Miami Miller School of Medicine. “The statistics show that patients have in fact opted to
see their doctor for an online video consult,
and, for non-urgent or critical matters.
“I believe that we will see more of this as a
method to increase access to care,” Dr. Awdeh
added. “As technology continues to improve, I
envision mobile diagnostics and patient moni-
toring to become a part of patient care.”
According to the survey, 7% of the respondents who had been with their physician for
less than 1 year said they would switch physicians to get online video visits. Additionally,
10% of the respondents who had been with
their physician for 2 to 4 years said they would
switch as well.
Younger people were more likely to express
willingness to switch to a physician who offered video visits, as 11% of patients between
the ages of 18 and 34 said they would switch,
while 8% of patients aged 35 to 44 years old
said they would switch.
However, there were situations where patients would not defer to video physician visits.
When asked what they would prefer to do
should a loved one need medical attention
during the night, 44% of patients said they
would go the emergency room. Another 21%
of patients chose video visits; 17% said they
would call a 24-hour nurse line, and 5% said
they would use an online-symptom checker.
Respondents with children under 18 years old
preferred video visits 30% of the time, which
the survey noted was higher than the overall
average of 21%.
Seventy-percent of patients said they would
prefer to receive their prescriptions through online video visits versus an in-person office visit.
Interestingly, the survey asked respondents
if they felt video visits should be less expensive than an office visit. The majority (62%)
of patients said video visits should be more affordable than in-person visits. Only 22% said
they should be near the same price, while 5%
said they should cost more.
Regardless, Dr. Awdeh said he believes mobile health will only lead to positive changes
for physicians and their patients.
“These technologies will ultimately improve
patient care and provide for an enhanced patient journey and doctor-patient relationship,”
he said. ■
24
Special Report )
REFRACTIVE SURGERY
Novel intraoperative aberrometer
enables better surgical outcomes
Device continuously samples wavefront several times/second for immediate feedback on refraction
By Cheryl Guttman Krader; Reviewed by Ronald R. Krueger, MD, MSE
CL E VEL AND ::
A NOVEL INTRAOPERATIVE ab-
B
errometer with a new sequentially shifting
wavefront device (HOLOS IntraOp, Clarity
Medical Systems) brings diagnostic precision
in cataract surgery to a level that meets the
therapeutic precision of premium IOL and
femtosecond laser technology, according to Ronald R.
Krueger, MD, MSE.
“Despite advances in preoperative measurements and
methods for improving the
accuracy of toric IOL alignDr. Krueger
ment, about 20% of patients
require some kind of enhancement to correct
refractive error after cataract surgery,” said
Dr. Krueger, medical director, Department of
Refractive Surgery, Cole Eye Institute, CleveAs the aperture moves along an annulus, the
land Clinic, Cleveland.
“Real-time intraoperative aberrometry for sampled wavefront segment is focused onto a
measurement of astigmatism and confirma- quad detector that senses the location of the
tion of IOL power has the potential for refin- scanned spot as a function of the detection geing any of the preoperative measurements we ometry. Refraction is determined by the magare making,” Dr. Krueger said. “Therefore, nitude and axis of displacement of the rapidly
it should lead to better refractive outcomes, scanned spot.
The refractive measurements are
which is important in the current
displayed qualitatively using outera where success in cataract surlines of geometric shapes. Spherigery is measured by uncorrected
cal refractive error is represented
visual acuity.”
by a circle, cylinder as a line along
The intraoperative aberrometer
A new sequentially
its axis, and these two shapes colis a miniaturized wavefront device shifting wavefront
lapse into a dot when emmetropia
that attaches onto the bottom of device for
is achieved. Quantitative refractive
nearly any operating microscope. intraoperative
data are also presented.
“The device is very simple to in- aberrometry provides
All of the information is genertegrate into the surgical environ- continuous feedback
ated in real-time, without the surment. It does not compromise ergo- on refraction during
geon having to push a button to
nomics for the surgeon or the scrub cataract surgery.
capture the refraction, and seen in
nurse, and with its thin profile,
sufficient clearance is maintained for surgical a heads-up display on a color monitor.
“The device continuously samples the waveinstrument handling,” said Dr. Krueger, who
is also professor of ophthalmology, Cleveland front at a rate of several times per second and
Clinic Lerner College of Medicine, Case West- provides immediate feedback to the surgeon
about the refraction, which is important conern Reserve University, Cleveland.
sidering the number of variables that can affect
the measurement,” Dr. Krueger said.
HOW IT WOR KS
“For example, if the speculum moves and
The aberrometer uses a rotating prismatic mirror that rapidly shifts the incident wavefront bumps the orbit, the refraction will change,
from the eye through a variable-size aperture. but the surgeon will know immediately that
take-home
Method
of action for
sequentially
shifting
aberrometry
in creating a
“wavefront
movie.”
Heads-up display gives both real-time
numerical refractive data and a qualitative
magnitude of myopia (red circle) and
astigmatism with axis (light blue line). (Images
courtesy of Ronald Krueger, MD; bottom image, Warren Hill, MD)
something has happened,” he said. “The competitor intraoperative aberrometer has been
enhanced with technology that provides continuous streaming refractive data, but the actual measurement is still a snapshot, which
can be misleading.” ■
RONALD R. KRUEGER, MD, MSE
E: Krueger@ccf.org
This article was adapted from Dr. Krueger’s presentation at the 2014 meeting of the
American Academy of Ophthalmology. Dr. Krueger is a consultant to Clarity Medical
Systems, but has no other relevant financial interests to disclose.
Special Report )
25
REFRACTIVE SURGERY
Navy study reaffirms LASIK surgery
with excellent, objective outcomes
Clinical, patient-reported results show benefits far outweigh the risks of procedure
By Cheryl Guttman Krader; Reviewed by Capt. Elizabeth M. Hofmeister, MD
CHICAGO ::
RESULTS FROM THE PATIENT
Reported Outcomes with LASIK-1 (PROWL-1)
provide further evidence that LASIK surgery is
associated with excellent objective clinical and
patient-reported outcomes, but also serve as a reminder that no surgical procedure is without risk.
PROWL-1, conducted at the Navy Refractive
Surgery Center, San Diego, represents phase II of
the LASIK Quality of Life Collaboration Project
that was undertaken as a government partnership involving
the FDA, National Eye Institute,
and Department of Defense.
Capt. Elizabeth M. Hofmeister, MD, refractive surgery advisor for Navy Ophthalmology,
Dr. Hofmeister
and assistant professor of surgery, Uniformed Services University, presented
the PROWL-1 data at the annual meeting of
the American Academy of Ophthalmology on
Oct. 19, 2014.
PR OW L-1 F I N DI N G S
In PROWL-1, 242 active duty military personnel were
operated on by four surgeons using standardized
techniques, a femtosecond laser for flap creation,
and either a wavefront-guided or a wavefront-optimized excimer laser platform. Clinic visits and
online questionnaires collecting patient-reported
outcomes were conducted at 1, 3, and 6 months
postoperatively; the 6-month assessments were
completed by 90% of operated patients.
At 6 months 99.5% of subjects achieved 20/20
or better uncorrected visual acuity, the majority
of patients had gained ≥1 line of best-corrected
visual acuity (BCVA) compared with preoperatively, no patient had lost >1 line of BCVA, 98%
of patients were satisfied with the result of their
surgery, and 97% were satisfied with their vision.
The results also showed that visual symptoms and dry eye-related findings developed de
novo in some patients after surgery, but these
issues affected many patients preoperatively
who tended to see improvement postoperatively.
“The goal of the Navy Warfighter Refractive Surgery Program is to improve the safety
and operational readiness of our service mem-
months. The OSDI data showed
bers,” Dr. Hofmeister said. “Feedonly 55% of patients had a norback received from our patients
mal score preoperatively.
show again and again that refracOverall scores for the cohort were
tive surgery makes them safer and
The Patient Reported
better at 1 month than preopermore effective as they work in dan- Outcomes with
atively and improved over time.
gerous and austere environments LASIK-1 study shows
Whereas up to 21% of patients with
around the world.
LASIK surgery had
a normal preoperative OSDI score
“However, while we have looked excellent efficacy
had a score indicating mild, moderextensively at postoperative symp- and safety, resulted
ate or severe dry eye at 6 months,
toms, especially as they affect visual in very high patient
70% of those cases were mild, and
performance and night vision, we satisfaction, and was
65% of the subgroup of patients
have never conducted an anonymous more often followed
who had dry eye preoperatively
computer-based survey,” she said. by improvements in
based on their OSDI score had a
PROWL-1 is the first prospective dry eye and visual
normal score at 6 months.
study to evaluate multiple aspects symptoms than
“It was interesting to see that our
of patients’ experience with LASIK, worsening.
patients had a significant amount of
including expectations, satisfaction,
visual symptoms, and their impact on function. dry eye complaints preoperatively and that these
The results provide important data to further symptoms improved for the cohort after surgery,”
enhance our discussion with patients about the Dr. Hofmeister said. “Although the conventional
risks and benefits of surgery, Dr. Hofmeister said. wisdom is that LASIK causes dry eye, there are
The PROWL-1 population included mostly several factors that can account for our results.”
Listing the explanations, Dr. Hofmeister noted
men (79%) and eyes with myopia/myopic astigmatism (>90%). About half of the participants that LASIK gets patients out of their contact
were using contact lenses as their primary lenses. In addition, all patients who have LASIK
are prescribed topical lubricant drops and those
means of correction prior to LASIK.
The online questionnaire asked patients about identified to have meibomian gland dysfuncghost images, glare, halos, and starburst. Pre- tion are encouraged to treat their disorder with
operatively, these symptoms were present in warm compresses and omega-3 supplements.
Only 4 patients were dissatisfied with their
between 29% and 49% of patients. Only halos
was reported at a higher rate postoperatively LASIK surgery at 6 months and 6 patients were
than preoperatively, and only at 1 month as the dissatisfied with their vision. The small numincidence of halos and all other visual symp- ber of dissatisfied patients precluded valid statistical analyses to identify associated factors.
toms steadily declined from 1 to 6 months.
Qualitative comparisons were untaken and
“Very few patients, <1%, noted that their
visual symptoms had affected their ability to showed the satisfied and dissatisfied groups
perform daily activities,” Dr. Hofmeister said. were similar in terms of residual refractive
error, and the dissatisfied patients had slightly
lower higher-order aberrations.
DRY EYE-R ELATED FINDINGS
However, the dissatisfied patients seemed more
Dry eye was assessed using the six-point Oxford score to rate lissamine green corneal and likely to report visual symptoms and 2 of the 6
conjunctival staining, and symptoms were rated dissatisfied patients had severe OSDI scores. ■
as normal, mild, moderate, or severe based on
Ocular Surface Disease Index (OSDI) scores.
CAPT. ELIZABETH M. HOFMEISTER, MD
Summarizing the results, Dr. Hofmeister said
E: elizabeth.hofmeister@med.navy.mil
the Oxford score data for the cohort showed an
Dr. Hofmeister has no relevant financial interests to disclose. The views expressed are
increase in staining at 1 month after surgery
her own and do not necessarily reflect the official policy or position of the Department
with improvement toward baseline at 3 and 6
of the Navy, Department of Defense, or the U.S. Government.
take-home
26
Special Report )
REFRACTIVE SURGERY
Compounded combination drops safe,
effective for postLASIK management
Approach provides cost, convenience advantages compared with regimens using individual agents
By Cheryl Guttman Krader; Reviewed by William F. Wiley, MD
CL E VEL AND ::
PROPRIETARY COMPOUNDED topical corticosteroid-antibiotic combination products (LessDrops, Imprimis Pharmaceuticals)
are safe and effective for postLASIK medical
management, according to
William F. Wiley, MD.
In addition, they provide
cost and convenience advantages compared with standard regimens using individual agents, said Dr. Wiley,
medical director, Cleveland
Dr. Wiley
Eye Clinic and its affiliated
laser center, Clear Choice Custom LASIK Center, Cleveland.
‘Our assessments showed that the compounded
products did what they were supposed to in terms of
controlling inflammation and preventing infection.’
– William F. Wiley, MD
“Some topical medications will cause burning or stinging on instillation, or they may be
slightly toxic to the corneal epithelium, which
could potentially decrease the ‘wow’ effect
of LASIK surgery,” he said. “Patients using
the compounded combination products did
not complain of discomfort or irritation, and
there was no evidence of delayed healing or
PAT IE N T SER IE S
visual recovery.”
Dr. Wiley evaluated the use of compounded
Dr. Wiley said he had been using the propriprednisone acetate-moxifloxacin HCl (Pred- etary compounded intravitreal corticosteroidMoxi, Imprimis Pharmaceuticals) and com- antibiotic products from Imprimis (Dropless
pounded triamcinolone acetonide-moxifloxacin Therapy) at the end of cataract surgery and
HCl (Tri-Moxi, Imprimis Pharmaceuticals) in was pleased with that experience.
a series of 60 patients who under“The ability to avoid drops after
went LASIK.
surgery was a big advantage and
Patients were randomly assigned
made me think a topical fixed
to use one product or the other and
combination of an antibiotic and
instructed to instill 1 drop twice
corticosteroid would be an attracPositive outcomes
a day for 1 week. When needed, were achieved in a
tive option for patients to use after
treatment was continued once daily clinical evaluation
LASIK,” he said.
for an additional week.
Although such a product would
of proprietary
Follow-up examination and pa- compounded topical
not eliminate the need for drops, it
tient reports showed outcomes were corticosteroidwould cut the number of adminissimilarly favorable with both for- antibiotic combination
trations in half, which would ease
mulations, and clinically, the pa- products for treatment
the treatment burden on patients
tients’ course was indistinguish- after LASIK.
and reduce the risk of inadvertent
able from that of patients using
trauma to the flap, he noted.
traditional single-agent drops.
Evaluations included measurement of refracDROPS R E A DY F OR USE
tion and visual acuity on the first day postop- As another benefit, since the drops are ordered
eratively and at 1 week after surgery. At 1 week, directly from the manufacturer and shipped
uncorrected visual acuity was 20/15 or better to the surgery center, their use ensures that
in 47% of eyes and 20/20 or better in 82%.
all patients will be ready to start their postop“Our assessments showed that the com- erative medications after surgery.
pounded products did what they were sup“Some patients will not have obtained their
posed to in terms of controlling inflammation medications when they arrive for LASIK, perand preventing infection,” Dr. Wiley said. “In haps because they failed to fill the prescripaddition, they were safe and well-tolerated.
tion due to cost or insurance issues or because
take-home
they misunderstood and thought we would be
providing the medications to them as part of
the surgical package,” Dr. Wiley said.
“Use of the compounded combination drops
avoids any confusion,” he said. “In addition, it
offers a value-added service. Patients appreciate the convenience of getting the drops at the
surgery center, and every little thing helps in
today’s highly competitive LASIK marketplace.”
The compounded combination product is
also priced attractively at just around $50 per
bottle. Dr. Wiley noted that translates into a
significant cost savings as patients often pay
more than that amount for just one of the medications they need.
MAKING THE TR ANSITION
Based on the favorable outcomes of his evaluation, Dr. Wiley said he is transitioning to use
of the compounded corticosteroid-antibiotic
combination routinely for his LASIK patients.
However, he acknowledged that his evaluation was an informal assessment and that a
more rigorously designed clinical trial would
be needed to better understand how the two
formulations compare with each other and with
use of traditionally used single-agent regimens.
Imprimis Pharmaceuticals began fulfilling
prescription orders for the topical corticosteroidantibiotic formulations this month, according
to a prepared statement by the company. ■
WILLIAM F. WILEY, MD
E: drwiley@clevelandeyeclinic.com
Dr. Wiley has received compensation as a consultant to Imprimis Pharmaceuticals.
NOW APPROVED
ANTICIPATED RETAIL
AVAILABILITY MARCH 10
From Alcon, committed to providing new treatment options for patients.
Olopatadine is licensed from Kyowa Hakko Kirin Co., Ltd. Japan
©2015 Novartis
01/15
PAZ15017JAD
28
Special Report )
REFRACTIVE SURGERY
Ocular fixation, incision system elevates
outcomes of surgery for presbyopia
With scleral implant procedure, 96% achieved binocular DCNVA of J3 or better at 3 months
By Cheryl Guttman Krader; Reviewed by Barrie D. Soloway, MD
Once the docking station is in place, the proprietary scleratome is used to create the four
sion system is another step forward in improv- tunnels, which will be uniform in their posiing visual outcomes of scleral implant surgery tion (4 mm from the limbus), length (4 mm),
and depth (400 μm).
for presbyopia (VisAbility ProceWith the docking station still
dure, Refocus Group), according
in place, the shuttle assembly is
to Barrie D. Soloway, MD.
threaded through each tunnel, and
The system enables increased
then each PMMA implant is placed
consistency of scleral tunnel archiResults are analyzed
and locked into position.
tecture by providing fixation, dock- from a series of 28
ing, and incision guidance. With patients who underwent
its use, more patients are achiev- bilateral scleral implant
DATA A N A LY S I S
ing J3 or better distance-corrected surgery for presbyopia
Outcomes from procedures pernear visual acuity (DCNVA) and using a new ocular
formed with the ocular fixation
sooner after their surgery.
and incision system were analyzed
fixation and incision
“Since the scleral implant pro- system.
using data from 56 eyes of 28 pacedure for presbyopia was first
tients who underwent the binocuintroduced, there have been a series of re- lar procedure in Europe. Already at 1 month
finements in implant design, instrumenta- after surgery, near DCNVA was J3 or better in
tion, and surgical technique that have stan- 73% of eyes monocularly, and the proportion
dardized and simplified the surgery and led of eyes achieving that outcome increased to
to better results,” said Dr. Soloway, direc- 87% at 3 months and 93% at 6 months.
tor, New York Eye and Ear Infirmary Vision
Binocular DCNVA was even better with 96%
Correction Center, and assistant professor of of patients in the European cohort reading J3
ophthalmology, New York Medical College, or better among seen at 3 months.
New York.
Those results were compared with outcomes
from eyes enrolled in the U.S.
IDE study, which were operated on with an earlier-generation scleratome and without
the ocular fixation device. In
the U.S. IDE cohort, only 64%
of eyes achieved J3 or better
DCNVA at 1 month. The proportion achieving that outcome
— Barrie D. Soloway, MD
continued to increase as follow-up lengthened.
However, it still only reached 76% at 6 months,
“As the latest advancement, the ocular fixation device makes the procedure faster and Dr. Soloway noted.
easier,” he said. “In addition, it assures secure,
BE N E F I T S OF NOV E L C ONC E P T
uncomplicated, and consistent placement of the
scleral implants. These advantages appear to The scleral implant procedure is intended to
improve near vision in presbyopic emmetropes
translate into clinically superior outcomes.”
by expanding scleral tissue around the lens,
thereby increasing the circumlental space and
HOW IT WOR KS
The docking station fixes at the limbus, holds restoring physiological conditions necessary
the eye steady, and eliminates the need for for accommodation.
Relative to other surgical modalities for
manual marking of the scleral tunnel sites.
NE W YORK ::
A NEW OCULAR FIXATION and inci-
take-home
‘[The device] assures secure,
uncomplicated, and consistent
placement of the scleral implants.’
Once the docking station is in place, the
proprietary scleratome is used to create the
four tunnels.
With the docking station still in place,
the shuttle assembly is threaded through
each tunnel, and then each implant is
placed and locked into position.
VIDEO Go to http://bit.ly/1FU6Fz2
(Images/video courtesy of Refocus Group)
presbyopia, the scleral implant procedure
has several attractive attributes, according
to Dr. Soloway.
“The scleral implant surgery is a reversible, binocular, extraocular procedure that is
performed outside the visual axis,” he said.
“Unlike monovision or multifocal procedures
it does not affect distance vision and it affords
patients a full range of vision from far through
intermediate to near.”
In addition, it has been associated with a
favorable safety profile as there have been few
ocular adverse events and no reports of ocular disturbances such as halos or starbursts
that can occur with multifocal IOLs, he said. ■
BARRIE D. SOLOWAY, MD
E: bds@ihateglasses.com
Dr. Soloway is medical director for Refocus Group and a paid consultant.
Special Report )
29
REFRACTIVE SURGERY
Recent advances address challenges
of persistent epithelial defects
Several novel experimental approaches also show promise for management of PEDs
By Cheryl Guttman Krader; Reviewed by Bennie H. Jeng, MD
BALT IMORE ::
ADVANCED MEDICAL AND surgical
approaches are helping to address the challenge
of treating persistent epithelial defects (PEDs).
In addition, several novel investigational strategies are also showing promise for the management of this uncommon, but potentially sightthreatening condition, said Bennie H. Jeng, MD.
“Conventional medical management of PED
can be arduous for the ophthalmologist and a
burden on the patient,” said Dr. Jeng, professor
and chairman, Department of Ophthalmology
and Visual Sciences, University of Maryland
School of Medicine, Baltimore.
“Surgical options exist when standard medical therapies fail, but several advanced treatment modalities have been proven to be very
useful,” he said. “Should all else fail, experimental approaches are also under investigation and showing promise for helping our most
challenging cases.”
A SYSTEM ATIC A PPROACH
The first consideration to achieve healing of
a PED is to identify and control any underlying etiology, such as exposure keratopathy or
other eyelid abnormalities.
A second principle is to withdraw medications that are potentially toxic to the corneal
epithelium.
“The latter strategy is often overlooked because the focus is on treating with medications
rather than taking them away,” Dr. Jeng said.
Treatment for PED may be initiated with standard medical approaches based on frequent use
of preservative-free lubricants with or without
punctal occlusion, a soft bandage contact lens,
or pressure patching.
If the PED does not heal, epithelial debridement may be an effective technique that works
by removing thickened, stagnant epithelium from
the borders of the defect, which may be acting
as a barrier to the migration of healthy cells.
Tarsorrhaphy can also be an effective surgical option for promoting PED healing. Use of
a conjunctival flap or limbal stem cell transplantation in eyes with stem cell deficiency
are other surgical options.
In the past 10 to 15 years, several advanced ryl suture in a purse-string fashion. After trimoptions have been introduced for managing PED ming the edges, the amniotic membrane is covrefractory to conventional methods. Success- ered with a contact lens. Placement of a scleral
ful treatment of PED with autologous serum lens has also demonstrated efficacy for healing
was first described by Tsubota et
PED. When using this technique,
al. in 1999. Using 20% autologous
lenses of at least 17.5 mm diameter
serum 6 to 10 times/day, 44% of 16
should be chosen since the smaller
eyes healed within 2 weeks, and
diameter, mini-scleral lenses do not
almost two-thirds of eyes healed
completely vault over the cornea.
Autologous serum
by 1 month.
The larger-diameter scleral lenses
drops, amniotic
Dr. Jeng—in a paper written with membrane, and
are available from a variety of manWilliam J. Dupps Jr., MD, PhD—re- scleral lenses offer
ufacturers or as the custom-manported slightly higher healing rates advanced options
ufactured PROSE (Prosthetic Reusing 50% autologous serum drops for management of
placement of the Ocular Surface
to treat 25 eyes. Other investiga- persistent epithelial
Ecosystem, Boston Foundation for
tors have achieved similar or better defects refractory to
Sight).
outcomes as well, he noted.
standard treatment
“We found the time to healing modalities.
O T H E R A DVA N C E S
increased proportionally as the
Modalities under investigation for
time between PED onset and autreatment of PED include thymosin
tologous serum treatment initiation increased,” beta 4 and a connexin43 antisense gel (NexaDr. Jeng said. “That relationship suggests a gon, CoDa Therapeutics)—both of which have
potential role for using autologous serum as shown promise in compassionate-use cases.
early aggressive management of corneal epiThymosin beta 4 is a synthetically produced
thelial defects to prevent development of PED copy of a 43-amino acid peptide that is found
in eyes at high risk.”
in most tissues and has been shown to proResults of some published controlled stud- mote corneal wound re-epithelialization, deies support that approach, he noted. Treatment crease inflammation, and inhibit apoptosis.
with autologous serum has been reported to
The connexin43 antisense agent decreases
expedite graft re-epithelialization after pene- the upregulation of connexin proteins that metrating keratoplasty—particularly in patients diate bystander cell death (apoptosis induced
with diabetes—and to accelerate closure of by dying epithelial cells).
corneal epithelial abrasions created for better
Mesenchymal stem cells—which are autolointraoperative visualization in diabetic patients gous adipose-derived multipotent cells—and a
undergoing vitrectomy.
variety of products derived from whole blood
are also being investigated for promoting epiAMNIOTIC MEMBR ANE
thelial healing. ■
Application of amniotic membrane offers another advanced technique for managing PED. Reference
1. Katzman LR, Jeng BH. Management strategies for
It is available as both fresh-frozen (Amnion,
persistent epithelial defects of the cornea. Saudi J
Bio-Tissue) and freeze-dried tissue (Ambiodry2,
Ophthlamol. 2014;28:168-172.
IOP Ophthalmics) and also with a self-retaining PMMA device (ProKera, Bio-Tissue Inc.).
The advantage of the freeze-dried tissue in that
BENNIE H. JENG, MD
it has a much longer shelf life, Dr. Jeng noted.
E: bjeng@som.umaryland.edu
He said he personally prefers the frozen tisThis article was adapted from Dr. Jeng’s presentation during Cornea Subspecialty
sue, and he fixates it onto the ocular surface
Day at the 2014 meeting of the American Academy of Ophthalmology. Dr. Jeng is a
at the limbus with a single-running, 8-0 Vicconsultant to Jade Therapeutics, Kedrion, and Santen.
take-home
30
Special Report )
REFRACTIVE SURGERY
SMILE using femtosecond laser
brings benefits for treating myopia
Flapless procedure has less biomechanical impact on cornea, provides higher optical quality
90%
0.80
80%
0.70
SMILE
0.60
LASIK
70%
60%
50%
SMILE
40%
LASIK
30%
p<0.001
SMILE
LASIK
PTTS (%)
73±4
(65 to 82)
57±6
(45 to 72)
20%
10%
0%
0.00 -1.00 -2.00 -3.00 -4.00 -5.00 -6.00 -7.00 -8.00 -9.00
Maximum Myopic Meridian Treated (D)
Change in Spherical Aberration (μm)
Postoperative Relative Tensile Strength (%)
By Cheryl Guttman Krader; Reviewed by Dan Z. Reinstein, MD
= -0.0725x – 0.2621
R2 = 0.4964
= -0.0299x + 0.1543
R2 = 0.154
0.50
0.40
0.30
0.20
0.10
0.00
-0.10
-0.20
-0.30
0.00 -1.00 -2.00 -3.00 -4.00 -5.00 -6.00 -7.00 -8.00 -9.00
Maximum Myopic Meridian Treated (D)
LEFT The difference between SMILE and LASIK is understandable knowing that the flap-side cut, not the delamination, is responsible for the reduction in cornea
tensile strength after LASIK, said Dan Z. Reinstein, MD. RIGHT SMILE induces less spherical aberration than LASIK. (Figures courtesy of Dan Z. Reinstein, MD)
ACCUMULATING DATA demonstrate
that for patients with myopia seeking refractive surgery, there are many reasons to consider small incision lenticule extraction (SMILE)
performed with a proprietary
femtosecond laser (VisuMax,
Carl Zeiss Meditec).
“The refractive outcomes
for treating myopia and cylinder are equivalent if not better with SMILE compared with
Dr. Reinstein
LASIK, and the results are more
predictable with SMILE when treating myopia
greater than –8 D,” said Dan Z. Reinstein, MD,
MA (Cantab), FRCSC, DABO, FRCOphth, FEBO.
“In addition, SMILE avoids flap-related concerns and variables affecting excimer laser
treatment delivery, which may explain while
SMILE has greater accuracy for correcting high
myopia,” said Dr. Reinstein, medical director,
London Vision Clinic, London, and clinical professor of ophthalmology, Columbia University
Medical Center, New York.
MERITS OF PROCEDUR E
SMILE also has less biomechanical impact on
the cornea, provides higher optical quality,
and is associated with less neurotrophic epitheliopathy, he noted.
Discussing procedure effects on corneal bio- a larger optical zone in order to reduce the inmechanical integrity, Dr. Reinstein said that duction of spherical aberration.
“With SMILE there is about 65% less spherithe difference between SMILE and LASIK is
cal aberration induced than with
understandable knowing that the
a wavefront-optimized LASIK proflap-side cut, not the delamination,
cedure due to the ability to use
is responsible for the reduction in
a larger optical zone,” Dr. Reincornea tensile strength after LASIK
stein said. “However, SMILE still
and recognizing that the anterior
Small incision
reduces corneal tensile strength
stroma is twice as strong as the lenticule extraction
less than LASIK. Furthermore, the
posterior stroma.
(SMILE) results in
predictability of the spherical ab“SMILE is a flapless procedure in similar or better
erration change is also much betwhich the anterior stromal lamel- refractive outcomes
ter for SMILE than LASIK.
lae remain uncut,” he explained.
compared with LASIK
“Since SMILE induces less spheriEvidence that SMILE has an ad- for the treatment of
cal aberration than LASIK, it is irrelvantage over LASIK in its effect on myopia and with a
evant that there is not a SMILE wavecorneal biomechanics was first dem- number of advantages.
front-guided procedure,” he said.
onstrated in a mathematical model
Two clinical studies are currently under way
developed by Dr. Reinstein and colleagues.
Subsequently, they applied the model to actual investigating SMILE for hyperopia. Dr. Reinclinical cases and found that the model pre- stein is working with Kishore Pradhan, MD,
dicted that corneal tensile strength was about in Kathmandu, Nepal, whereas another study
30% greater in eyes that underwent SMILE is being run by Walter Sekundo, MD, in Marcompared with an age-matched LASIK group burg, Germany. ■
across the entire range of myopia treated (up
to –8 D).
Dr. Reinstein pointed out that the difference
DAN Z. REINSTEIN, MD
favoring SMILE occurs despite the fact that for
E: dzr@londonvisionclinic.com
a given correction, SMILE removes more tisThis article was adapted from Dr. Reinstein’s presentation during the 2014 meeting of the
sue than LASIK because he had chosen to use
American Academy of Ophthalmology. Dr. Reinstein is a consultant to Carl Zeiss Meditec.
take-home
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32
Special Report )
REFRACTIVE SURGERY
Bowman layer implantation looks
promising for advanced keratoconus
Procedure provides alternative to PK, DALK; avoiding associated complications
By Vanessa Caceres; Reviewed by Jack Parker, MD
BIRMINGHAM, AL ::
(FIGURE 1) A. With
a narrow slit beam,
the Bowman layer
implant (white
arrows) is visible
within the recipient’s
stroma 6 months
postoperatively. B.
Nevertheless, the
cornea is clear,
without any interface
haze or stromal
reaction. (Images courtesy
THE USE OF BOWMAN LAYER
implantation may be a way to halt progressive advanced keratoconus, according to Jack
Parker, MD.
This alternative treatment for advanced
keratoconus could help avoid complications
associated with the current treatment options of penetrating keratoplasty (PK) or deep
anterior lamellar keratoplasty (DALK), said
Dr. Parker, UAB Callahan Eye Hospital, Birmingham, AL.
“Traditionally, the management of keratoconus has consisted of a contact lens fitting
as long as possible and then a PK or DALK
reluctantly,” he said. “I say ‘reluctantly’ not
because these surgeries don’t work, but because of their frequent complications—such
as wound healing difficulties, suture-related
problems, progression of disease in the recipient rim, and persistent irregular astigmatism
in the graft.”
of Jack Parker, MD)
A
B
ing the Bowman layer, we can mechanically
bolster and shore up the cornea, protecting it
from further ectactic progression.”
Dr. Parker presented the results from the
first 22 eyes of 19 patients with advanced progressive keratoconus. All patients received a
Bowman implant delivered into the midstroma,
POPULARITY OF CXL, RINGS
There is a strong desire by surgeons to treat and were followed for an average of 2 years,
keratoconus early on to avoid PK or DALK and but some for up to 3 years.
“The goals were to halt ectasia
their related complications, he said,
progression, improve vision by flatnoting that this has spurred the
tening the cornea into a more norpopularity of corneal crosslinkmal anatomy, and avoid the coming (CXL) and intracorneal ring
plications associated with PK and
segments to stabilize the eyes.
Results were
DALK,” Dr. Parker said.
“The problem is that eyes with encouraging from
Dr. Parker explained what an
advanced keratoconus—steeper patients in a small
isolated Bowman layer graft looks
than 60 D or thinner than 350 study group receiving
like and said that the fellow reμm—aren’t candidates for corneal Bowman layer
searchers have previously decrosslinking or intracorneal ring implantations to treat
scribed stripping it from the ansegments,” Dr. Parker said. Kera- advanced keratoconus.
terior stroma.1
toconus often progresses in these
eyes with steep or thin corneas, and then paIn 90% of patients, the corneas flattened, intients must undergo PK or DALK.
dicating that ectasia progression had stopped.
To help avoid this, Dr. Parker and a team
“That is the same success rate as corneal
of Dutch researchers, including Gerrit Melles, crosslinking or intracorneal segments,” he
MD, PhD, Amsterdam, theorized the idea of said.
implanting an isolated Bowman layer in these
He also described Scheimpflug imaging of a
patients.
cornea that had flattened by about 8 D.
“Bowman layer fragmentation is one of the
The average best spectacle-corrected visual
earliest and most significant changes in kera- acuity improved from 20/400 preoperatively
toconus,” Dr. Parker said. “Perhaps by replac- to 20/25 postoperatively and contact lens vi-
take-home
sion remained unchanged. “That was a fairly
significant advancement for many patients,”
he said.
COMPLICATIONS
There were two complications in the study
group. In two cases, intraocular Descemet
membrane perforations inadvertently occurred during the manual dissection of the
midstromal pocket. Surgery was aborted in
both cases, perforations were allowed to heal,
and—in both—Bowman layer implantation
was successfully re-attempted at a later date.
“The operation looks to be promising, safe,
improves people’s vision, and avoids many of
the common complications that are the worst
bane of people with DALK and PK,” Dr. Parker
concluded. ■
Reference
1. Lie J, Droutsas K, Ham L, et al. Isolated Bowman layer
transplantation to manage persistent subepithelial
haze after excimer laser surface ablation. J Cataract
Refract Surg. 2010;36:1036-1041.
JACK PARKER, MD
E: jack.parker@gmail.com
This article was adapted from Dr. Parker’s presentation at the 2014 meeting of the
American Academy of Ophthalmology. Dr. Parker did not indicate any proprietary
interest in the subject matter.
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34
technology
New tool marks incision sites
for PPV, intravitreal injection
Fixed-pointer setting lets incision spots be placed correct distance apart with accuracy
By Nancy Groves; Reviewed by T.S. Melki, MD
mies, since intravitreal injections were rarely
he introduction of a new oph- given in an office setting.
Before this marker was developed, the only
thalmic marker (Melki 3.5-mm
available caliper for vitrectom a r k e r, R h e i n
mies was adjustable. The surMedical) lets surgeon would ask an assistant
geons accurately,
for caliper set at a specific
safely, and quickly
The Melki 3.5 mm
distance, then double check
mark the incision
ophthalmic marker
with the assistant to verify
site on the scleral surface for
is designed to help
the measurement.
pars plan vitrectomy (PPV) or
ophthalmologists
“I didn’t like this waste of
various office-based intravitsafely and accurately
time to go back and forth to
real injections.
mark incision sites
look at the numbers,” said
With the new marker’s fixedfor pars plana
Dr. Melki, who is in private
pointer setting, the incision
vitrectomy and
practice, Rockville, MD, and
spots can be placed the correct
intravitreal injections.
serves as associate professor,
distance apart without doubleGeorgetown University, Washchecking. Since the device has
no moving parts, inaccuracies due to wear and ington, DC. He is also director of The Rettear of the setting mechanism will not occur ina Centers of Washington.
over time and affect measurements.
This is critical in procedures—such as vitFILLING MARKET
rectomies or inravitreal injections—in which
NICHE
the incision points in the pars plana must be As intravitreal injections became more comexactly 3.5 mm from the limbus. If the loca- monly performed in outpatient settings, Dr.
tion is outside of the pars plana, the lens could Melki modified the marker for use in these
procedures as well as
surgical vitrectomies.
The larger market for
the instrument encouraged him to patent the
marker and form a relationship with Rhein
Medical to distribute it.
“We are now using
— T.S. Melki, MD
it a lot in the office, because we can do all the
injections more safely,”
be damaged—increasing the risk of cataract, Dr. Melki said. “With 1.5 million intravitreal
retinal tear, or detachment, said T.S. Melki, injections given in the United States alone
every year, there is tremendous need for the
MD, who developed the device.
marker. It’s quick, reusable, and you know you
can go in safely without injuring the retina or
M O T I VA T I O N F O R
injuring the lens.”
INVENTION
In the past 7 years, Dr. Melki said he used
Dr. Melki designed a prototype of the marker
about 20 years ago when he was a fellow. At the marker for several thousand injections
that time, it was used for surgical vitrecto- with no complications.
ROCK VIL L E, MD ::
T
MARKING THE INCISION SITE
TAKE-HOME
‘With 1.5 million intravitreal injections
given in the United States alone every
year, there is tremendous need for the
marker.’
VIDEO Watch as the marker is used
for marking the pars plana at 3.5 mm away
from the limbus. Go to http://bit.ly/1GFF6gq
(Video courtesy of Rhein Medical)
According to Dr. Melki, all retina surgeons can use the 3.5-mm marker regardless of whether they prefer 20-, 23-, or 25gauge instruments, since they all need to
mark their incision sites. The marker has
setting points dependent on the age of the
patient: 3.5 mm apart for adults, and 1 mm
apart for premature infants and infants less
than 3 months old.
The eye can be marked in a few seconds.
When a patient has been prepped for surgery or intravitreal injection, all the surgeon has to do is take the marker—which
has been soaking in betadine—and lightly
touch the sclera. The marker will leave a
dot of brown from the betadine, and that
will be the entry point.
“Another safety bonus is that the sclera has
been just painted with betadine, providing a
more sterile entry point,” Dr. Melki said. ■
T.S. MELKI, MD
P: 301/279-9123
E: Retina_1_@yahoo.com
Dr. Melki has a financial interest with Rhein Medical regarding this instrument.
drug therapy
35
No harmful effects of aspirin
tied to AMD progression
Random, controlled trials generally show protective, but not statistically significant, effect
By Nancy Groves; Reviewed by Emily Y. Chew, MD
sen and neovascular AMD, a finding that conongitudinal assessment of the progres- cerned many patients.
A second population-based study by Klein
sion of age-related macular degeneration (AMD) in the Age-Related Eye Dis- et al. also appeared in 2012 reporting recent
ease Study2 (AREDS2) demonstrated findings from the ongoing Beaver Dam Eye
no harmful association with aspirin Study, with 15 years of follow-up. Aspirin use
was defined as two times a week for more
use, according to Emily Y. Chew, MD.
This finding emerged from analysis of AREDS2 than 3 months. The risk of neovascular AMD
data from 2006 to 2012 using the statistical- more than doubled in patients who had been
taking aspirin regularly 10 years prior to an
matching technique of propensity scoring.
Although studies have explored the role of observed incidence.
aspirin use in AMD for more than 25 years,
several recent reports motivated the AREDS2
AREDS2 RESEARCH GROUP
investigators to perform their Dr. Chew reported the results on behalf of the
own study, said Dr. Chew, dep- AREDS2 Research Group.
uty director of the Division of
The AREDS2 Research Group analyzed a
Epidemiology and Applications group of 2,442 participants in the larger AREDS2
and the deputy clinical director clinical trial with no baseline geographic atof the National Eye Institute, rophy or neovascular AMD.
National Institutes of Health,
Propensity scoring was used to estimate the
Dr. Chew
Bethesda, MD.
probability of a participant using aspirin given
According to Dr. Chew, a 1988 study sug- covariates, Dr. Chew explained.
gested that aspirin increases the risk of hemThis statistical method reduces bias from
orrhage in patients with AMD, but that theory confounding variables and matches aspirin and
was countered by another study a year later non-aspirin users so that they are comparable
finding no difference.
in other aspects. Logistic reMore recently, at least one
gression was used to calculate
clinic-based study showed that
propensity scores for each paObservational data
aspirin had a protective effect,
tient, based on aspirin use at
from the AREDS2
whereas another suggested a
baseline, and participants were
study suggests
harmful effect. However, large
matched by propensity score.
that aspirin use
population-based studies on asHazard ratios were then calis not associated
pirin use have generated the most
culated. The variables used to
with progression of
attention.
create the propensity score inage-related macular
A report from the European
cluded age, gender, race, edudegeneration or
Eye Study, published by de Jong
cation, smoking, hypertension,
development of
et al. in Ophthalmology in 2012,
diabetes, and angina.
geographic atrophy or
generated significant interest for
Aspirin users were more likely
neovascularization.
its conclusion that daily aspito be older, male, non-white, less
rin use would worsen macular
educated, be smokers, and have
degeneration and increase the
diabetes, hypertension, angina,
risk of progression to the neovascular form and other cardiovascular diseases.
of the disease. This cross-sectional study inHowever, these differences were not stacluded 4,691 patients over age 65; daily aspi- tistically significant when participants were
rin use was 17%.
matched by propensity score. A difference in
Results showed that patients on aspirin had age of as much as 30 years emerged in persons
a greater risk of intermediate and large dru- with the same propensity scoring, so age was
BE T HESDA, MD ::
L
TAKE-HOME
included in the model, Dr. Chew said.
Investigators were also concerned about
death as a competing risk. Results for neovascular AMD without death as a competing
risk showed that age was significant (p <
0.0001) but aspirin use (propensity score) was
not (p = 0.3049); the hazard ratio was 0.60.
With an adjustment for death as competing
risk, the hazard ratio for aspirin use was 0.52
(p = 0.1834). Age was significant in these two
analyses as well as all others.
Results for development of geographic atrophy showed a hazard ratio of 1.04 without
death as a competing risk and when the data
were adjusted for death. The hazard ratios for
aspirin use were 1.31 (p = 0.5688) and 1.13
(p = 0.8032), respectively.
“Longitudinal assessment shows that there
is no harmful association with aspirin use,”
Dr. Chew said.
She added that randomized, controlled clinical trials of aspirin use generally show a protective, though not statistically significant, effect. Among population-based studies, only
the Beaver Dam Eye Study and the European
Eye Study are in contradiction of the AREDS2
findings.
“The totality of evidence—especially the information from the randomized clinical trials
of aspirin—suggests that there are no harmful
effects of aspirin associated with the progression of AMD,” Dr. Chew said.
“We suggest that individuals with AMD
should consider aspirin therapy when medically indicated,” she added. “Especially now
when we have good treatment for neovascular AMD, it’s much more important for these
patients to take the aspirin that is required for
their cardiovascular disease and other medical conditions that are of concern to them.” ■
EMILY Y. CHEW, MD
P: 301/496-6583
E: echew@nei.nih.gov
This article was adapted from Dr. Chew’s presentation during the 2014 meeting of
the American Academy of Ophthalmology. Dr. Chew reported no financial interests or
relationships.
36
drug therapy
Dexamethasone for DME shows stronger
results compared with sham group
Subgroups defined by demographics, diabetes status, duration of disease, prior treatment
By Vanessa Caceres; Reviewed by Anat Lowenstein, MD
T EL AVIV, ISR AEL ::
THE BENEFITS of treatment with a dexamethasone intravitreal implant (Ozurdex, Allergan) for diabetic macular edema (DME) were
found in a variety of subgroups.
These groups were defined by demographics, diabetes status, diabetes and DME duration, prior treatment, and severity of diabetes,
according to Anat Lowenstein, MD, Tel Aviv
Sourasky Medical Center, Tel Aviv, Israel.
S U B G R OU P A N A LY S I S
Dr. Lowenstein presented the results of a subgroup analysis of the MEAD trial, focused on
3-year results with the dexamethasone implant
0.7 and 0.35 mg in 1,048 patients with DME.
The trial met its primary efficacy endpoint
of improvement in best-corrected visual acuity
(BCVA) stronger than that of the sham-controlled
group and had a safety profile consistent with
previous reports, according to study authors.1
Dr. Lowenstein described a typical patient
from the trial. The patient was a 65-year-old
with severe diabetic retinopathy in both eyes.
Despite focal laser therapy and three bevacizumab injections, the patient still had severe
DME. The patient was treated with the dexamethasone implant, responded nicely for 4 to 5
months, and then had another recurrence. The
patient developed a cataract and was treated
for it after the third use of the implant.
“At the last follow-up, with the seventh injection, the patient had good anatomic results,”
Dr. Lowenstein said.
Dr. Lowenstein also described the various
parameters under which the implant performed
better than the sham-controlled group, including mean change in BCVA from baseline at 3
years, a BCVA improvement of 15 letters or more
at 3 years, the time that it took to reach an improvement of 15 letters or more, and the mean
average change from baseline in ocular coherence tomography retinal thickness at the center
subfield. The numbers were clinically higher
in patients in the 0.35-mg group as well as the
0.7-mg group.
The improvements with the implant also
spanned a variety of demographic characteristics.
FN, 65-Year-Old Woman
> RE Regressed PDR (s/p PRP)
> LE Severe NPDR
> s/p RE Focal Laser + Intravitreal Bevacizumab X 3
BCVA – 20/80
CMT – 840 μm
(FIGURE 1) This is a 65-year-old female with severe diabetic retinopathy and resistant to treatment for
diabetic macular edema in the right eye still significant after focal laser and anti-vascular endothelial
growth factor therapy.
“The higher percentage of at least three lines
of improvement was seen with the dexamethasone implant across sex, age, and ethnic group,”
Dr. Lowenstein said.
Although statistics seemed to show a strikingly high result in patients under the age of 45,
that was likely because of a smaller sample size.
When analyzing vision improvement based
on diabetes and DME characteristics, there was
a higher percentage of at least three lines of improvement with the implant versus the sham
across diabetes duration (measured as fewer
than or greater than 15 years), HbA1C (less than
or greater than 8%), and duration of DME (broken down into year-long increments and then 3
years or longer), she said.
“There was a trend toward an increased benefit to dexamethasone in patients with a shorter
duration of disease and better control,” she said.
“However, the sample size is small.”
When analyzing patients’ prior treatments,
those receiving the implant once again saw a
benefit regardless of the previous type of therapy
or the type of DME they had, she said.
There was also a higher percentage of 15-letter improvement or greater in patients receiving
the implant regardless of their baseline ocular
BCVA or retinal thickness.
“The differential efficacy here is likely caused
by the ceiling effect and less thick retinas at
baseline, with less room for improvement possible,” Dr. Lowenstein said.
Study researchers also analyzed the benefit of
the implant in phakic versus pseudophakic eyes.
Although they observed a treatment benefit consistent at all time points in pseudophakic eyes,
drug therapy
this was not initially seen in the phakic eyes.
“When we looked at patients who underwent
cataract surgery, they eventually did gain the
same acuity benefits as pseudophakic patients,”
she said.
Finally, researchers analyzed how effective
the implant was in patients based on the severity of their diabetic retinopathy. “In patients with
diabetic retinopathy graded as severe NPDR or
worse, the implant was significantly more effective than sham in all visual acuity and retinal
thickness parameters,” she said. ■
Reference
1. Boyer DS, Yoon YH, Belfort R Jr, et al. Three-year,
randomized sham-controlled trial of dexamethasone
intravitreal implant in patients with diabetic macular
edema. Ophthalmology. 2014;121:1904-1914.
Mean change from
baseline BCVA (letters)
Mean BCVA Change From Baseline Based
on Baseline Lens Status
10
8
6
4
2
0
-2
Pseudophakic
0
3
6
DEX Implant 0.7 mg (n = 86)
Sham (n = 101)
9
12
15
18
21
24
27
30
33
36
39
36
39
Mean change from
baseline BCVA (letters)
Month
10
8
6
4
2
0
-2
Phakic
Sham (n = 249)
0
3
6
9
12
15
18
21
24
27
30
33
Month
> Treatment benefit was consistent each year of the study in pseudophakic study
eyes.
> Reduced treatment benefit after year 1 was seen in phakic eyes in the
dexamethasone implant-treated patients, suggesting outcomes confounded by
steroid-induced cataract.
(FIGURE 2) A subgroup division that did matter was that of lens status. Treatment
benefit was consistent each year of the study in pseudophakic study eyes. Reduced
treatment benefit after year 1 was seen in phakic study eyes in the dexamethasone
implant treatment groups, suggesting that outcomes were confounded by steroidinduced cataract.
Patients Who Underwent Cataract Surgery
Eventually Gained the Same Visual Benefit as
Pseudophakic Patients
Baseline
pseudophakic
patients
Phakic patients with cataract adverse event (AE)
Mean average change
in BCVA from baseline
(ETDRS letters)
10
5.3
5
0
4.8
DEX Implant 0.7 mg
DEX Implant 0.35 mg
6.7
4.3
7.1
4.7
6.5
5.9
(132) (118)
(176) (159)
(142) (123)
-5
-7.0
-10
(73) (63)
(86) (88)
>12 months
follow-up
-9.7
Baseline
to AE
AE to
cataract
surgery
After cataract surgery
Results analyzed in the ITT population with an area-under-the-curve approach
Numbers in parentheses indicate number of patients
(FIGURE 3) After cataract surgery and recovery, visual improvement in phakic eyes
treated with the dexamethasone implant reached the same level as in baseline
pseudophakic eyes. (Images courtesy of Anat Lowenstein, MD)
ANAT LOWENSTEIN, MD
E: anatl@tlvmc.gov.il
This article was adapted from Dr. Lowenstein’s presentation during Retina Subspecialty
Day at the 2014 meeting of the American Academy of Ophthalmology. Dr. Lowenstein
did not indicate any proprietary interest in the subject matter.
37
38
clinical diagnosis
PEDIG addresses binocular
treatment and patching
18th of Amblyopia Treatment Studies analyzes which approach stacks up against the other
By Lynda Charters; Reviewed by David K. Wallace, MD, MPH
DURHAM, NC ::
n the 18 years of the organization’s existence, The Pediatric Eye Disease Investigator Group (PEDIG) has tackled a number
of challenges.
Prime among them, according to PEDIG
Chairman David K. Wallace, MD, MPH, are
questions regarding how well glasses-alone
treat amblyopia, the effectiveness of patching
in older children, the effect of near activities
on the results of patching, and cessation of
visual acuity improvement
with patching.
The most current and 18th
of the Amblyopia Treatment
Studies (ATS) is a comparison of binocular treatment of
amblyopia with patching in a
randomized trial of children
Dr. Wallace
aged 5 to less than 17 years
old, with the primary goal of determining if
binocular treatment is noninferior to patching in younger children.
“If binocular treatment is just as good as
patching, then that would be a game-changer,
and we would likely want to offer this treatment option to parents,” said Dr. Wallace, professor of ophthalmology and pediatrics, Duke
Eye Center, Durham, NC.
I
least 16 weeks, or stable vision on two visits ment was superior, with 53% of those using
4 weeks apart. Patients will be randomly as- augmented treatment improving by 2 or more
signed to play the binocular game “Hess fall- lines, compared with 25% in the optical coring blocks” (similar to Tetris)
rection group. In the older chil1 hour daily or to 2 hours of
dren, augmented treatment did
daily patching.
not make a difference when inStudies by the
To be eligible for the study,
cluding those with/without prePediatric Eye Disease
patients must be able to align
vious treatments.
Investigator Group
the nonius cross in the game and
“There was an age effect over
have led to evidenceto score at least one line on the
time with differences in treatbased treatment of
game, Dr. Wallace explained.
ment,” he said. “There was no
amblyopia.
Patients will be assessed at
difference in the oldest patients.”
4, 8, 12, and 16 weeks for monHowever, when investigators
ocular distance visual acuity,
looked only at children who had
Randot stereoacuity, and ocular alignment, not been treated previously, improvement ocand patients and parents will complete a dip- curred even among those patients who were
lopia questionnaire.
older.
“So, patching often does work in older children, especially for those with no previous
HIGHLIGHTS OF THE ATS
Dr. Wallace reviewed some of the important treatment,” Dr. Wallace said.
Regarding spectacle use, ATS5 showed that
research published by the PEDIG that laid the
spectacle use alone improved amblyopia an avgroundwork for the most current study.
The earliest studies investigated the effects erage of almost 2 lines of vision after 5 weeks
of patching. In ATS1, investigators found that of therapy.
“This was a robust improvement with specpatching and atropine result in similar improvetacles alone,” he said.
ments after 4 months of treatment.
The same study also showed that after the
ATS2 dealt with the dosing of the initial
treatment. Two or 6 hours of patching resulted spectacle improvement stopped, patching for
in similar improvement of 2.4 lines of vision 2 hours daily resulted in more improvement
with moderate amblyo- than use of spectacles alone.
pia. In patients with seN E A R PAT CHI NG ACT I V I T IE S
vere amblyopia, 6 hours
of patching and full- The next step was a look at the effect of near
time patching had simi- activities on patching in ATS6. More than 400
lar results (4.8 and 4.7 young children 3 to less than 7 years of age were
lines of vision, respec- randomly assigned to near or distance activities
tively). When patching with 2 hours of patching daily.
The primary outcome at 8 weeks showed
was stopped, about 25%
of children lost 2 lines no difference in the mean improvement between the near and distance groups (2.5 and
or more of vision.
ATS3 evaluated 507 older children aged 7 2.6 lines of vision, respectively).
In children with severe amblyopia, “there
to 18 years who were randomly assigned to
optical correction alone versus optical correc- was a slight suggestion that near activities were
tion and patching and, for the younger chil- a bit beneficial at 17 weeks,” Dr. Wallace said.
“Near activities do not enhance the effect
dren only, atropine. Results indicated that in
children aged 7 to 12 years augmented treat- of patching, although there might be a small
‘If binocular treatment is just
as good as patching, then that
would be a game-changer.’
— David K. Wallace, MD, MPH
The second study goal is to determine if
binocular treatment is superior to patching
in older children.
Among the inclusion criteria is an amblyopic
eye visual acuity of 20/40 to 20/200 and wearing of appropriate spectacle correction for at
TAKE-HOME
clinical diagnosis
Five ways to optimize glaucoma care
By Cheryl Guttman Krader
S T. LOUIS, MO ::
IN ASSESSING patients with glaucoma,
ophthalmologists should look beyond the standard clinical metrics and consider how the disease may be impacting daily living.
The process begins by exploring problems
patients may have with five “Ds”—daily activities, driving, disability from falls, dual sensory
loss, and depression, said Anjali Bhorade, MD.
Asking about daily activities is important, as
many glaucoma patients have trouble with such
tasks as reading, writing, matching clothes,
mobility, and self-care, said Dr. Bhorade, associate professor of ophthalmology and visual
sciences, Washington University, St. Louis, MO.
Increasing home lighting and informing patients about low vision aids and services—such
as books on tape and various mobile apps—may
help address some problems. However, patients
may also benefit from referral to a low vision
occupational therapist or a low vision clinic.
positive effect in children with severe amblyopia,” he said.
An evaluation of bilateral refractive amblyopia in ATS7 found that
spectacles improved the binocular
vision by about four lines of vision
after 1 year of treatment.
OPTICAL TR EATMENT
ATS13 involved optical treatment of
strabismic amblyopia. Participants
were aged 3 to under 7 years, had
not previously worn spectacles or
received amblyopia treatment, and
had strabismus in spectacles. The
study found that after 18 weeks
of treatment in spectacles alone,
amblyopic eye visual acuity had
improved an average of 2.6 lines.
This raised an interesting question, according to Dr. Wallace: How
can amblyopia improve with spectacles alone when the child remains
strabismic in spectacles?
“Possibly the amblyopic eye fixes
during some activities and takes advantage of the newly focused image in
the glasses,” Dr. Wallace speculated.
Hearing loss is a common, but underrecognized and undertreated problem in older
patients. “If you ask about their hearing and
get no response, it is a good indicator for referring the patient to an audiologist for a hearing evaluation,” she jestered.
Asking about driving is important as vision
loss from glaucoma can compromise driver
safety, but also because some glaucoma patients
may be limiting their driving even though they
can drive safely. Ophthalmologists can refer
patients for an on-road driving evaluation and
then take further action based on the findings.
Patients who are deemed safe may still benefit from participating in a driving safety program or from conditional driving restriction.
Patients identified as unsafe to drive can be
referred to driving cessation programs that
connect participants with support groups and
alternative modes of transportation.
“Glasses-alone results in substantial improvement even in those patients who remained strabismic,” he
said. “The advantage of a trial of
glasses first is that some children
will never need patching or atropine.”
ATS15 tested the result of increased
patching after the positive effects of
patching stopped. These patients
were treated with 2 hours of patching daily. After the visual improvement stopped, they were randomly
assigned to 2 or 6 hours of daily
patching. After 10 weeks, investigators found that 6 hours was superior
to 2 hours, with 40% of children in
the 6-hour group achieving two or
more lines of improvement compared
with 18% in the 2-hour group. ■
DAVID K. WALLACE, MD, MPH
E: david.wallace@duke.edu
This article was adapted from Dr. Wallace’s presentation
during Pediatric Subspecialty Day at the 2014 meeting of the
American Academy of Ophthalmology. Dr. Wallace receives
funding from the National Eye Institute.
Patients with glaucoma are at increased risks
for falls. In addition to asking about these events,
ophthalmologists can look for clues, such as
whether the patient has bruises, casts, or braces.
Changing the patient’s glasses from bifocals
or progressive correction lenses to separate
distance and near glasses can enable greater
safety in maneuvering down stairs. A visit to
the home by an occupational therapist is also
useful for identifying any environmental hazards that can increase risk for falls.
Risk of depression has been shown to be
increased in patients with glaucoma, and is
higher as the level of visual field loss increases.
Patients who show signs and symptoms of depression should be referred to a mental health
specialist, but can also be counseled about
glaucoma support groups or the Glaucoma Service Foundation to Prevent Blindness online
chat room. ■
39
40
clinical diagnosis
DIY genetic testing for glaucoma:
Is there any value for clinicians?
Challenge exists with uncertainty for how to interpret risk genes discovered out of context
By Nancy Groves; Reviewed by Wallace L.M. Alward, MD
IOWA CI T Y, IA ::
GENETIC TESTING for glaucoma is useful in some cases, but is most likely to yield
clinically valuable information when ordered
by a physician and performed by a certified
laboratory.
Do-it-yourself (DIY) genetic testing, if available, is of little benefit since no one, including physicians, is certain how to interpret risk
genes discovered out of context, said Wallace
L.M. Alward, MD.
For now, ophthalmologists do not need to
worry about how to respond to patients who
are concerned with the results of a test they had
performed through a personal genome service
since these companies have been blocked from
marketing their products for medical purposes.
Test providers, such as 23andMe, can provide customers with information about their
genetic makeup based on blood tests but cannot provide disease risk profiles pending FDA
regulatory approval.
“I’m enthusiastic that understanding glaucoma genetics will one day have a huge impact
on diagnosis and therapeutics, but self-testing
[in 2015] doesn’t hold promise for glaucoma
diagnosis,” said Dr. Alward, the Frederick C.
Blodi Chair in Ophthalmology; vice chairman,
ophthalmology; director, Glaucoma Service;
and professor of ophthalmology and visual
sciences, University of Iowa Carver College
of Medicine, Iowa City.
GL AUCOM A GENE S
Dr. Alward discussed genetic testing, emphasizing the distinction between the two major
types of glaucoma genes: those in which a
single genetic change causes glaucoma, and
those in which a change slightly increases the
risk of developing glaucoma.
Disease-causing genes have typically been
discovered through family studies.
These include myocilin for juvenile-onset
open-angle glaucoma and primary open-angle glaucoma; CYP1B1 and LTBP2 for primary
congenital glaucoma; optineurin and TBK1 for
normal tension glaucoma; PAX6 for aniridia;
and PITX2 and FOXC1 for Axenfeld-Rieger Syn-
drome. A family member who carries one of was discovered in a large GWAS conducted
these genes is at high risk to develop the as- in Iceland. Individuals who are homozygous
for the highest risk alleles are 700 times more
sociated form of glaucoma.
Fee-for-service testing is available for almost likely to develop exfoliation syndrome than
all of these genes; GeneTests.org offers a list those with the lowest risk alleles. The catch
is that 25% of the population is homozygous
of all the labs that provide testing.
If a clinician believes that a patient may for the highest risk alleles.
“Most people who have the highest risk alhave the myocilin mutation, for example, the
test can be ordered for about $200 with results leles will never get exfoliation, and testing for
available in 12 to 14 weeks. Answering this it is not helpful,” Dr. Alward said. “It’s a huge
question may be very important to patients discovery and an important part of a complex
puzzle, but I don’t know or really care what
and their families.
my LOXL1 phenotype is.”
“Unfortunately, all of the
The American Academy of
known glaucoma genes today
Ophthalmology task force on
only cause about 5% of glaugenetic testing recommended
coma,” Dr. Alward said.
Do-it-yourself
in a 2012 report that ophthalFurther, the diagnosis can
testing for glaucoma,
mologists avoid routine genetic
often be made with a slit lamp
if and when
testing for genetically complex
exam, and a lab test would not
available, is of
disorders such as late-onset, pribe crucial. That said, genetic
limited diagnostic
mary open-angle glaucoma.
testing makes sense in some
value to clinicians,
“Hopefully that will change
cases.
in the view of one
when there are useful tests for
“If you have somebody who
ophthalmologist.
predicting the course or response
has all of the features of anto therapies,” Dr. Alward said.
iridia but still has an iris, you
He added that there are major, well-estabmight want to test for PAX6 mutations,” Dr.
Alward said. “I think myocilin testing is use- lished risk factors for glaucoma, such as IOP,
ful to do in someone with the classic juvenile pattern standard deviation, and central corneal
onset glaucoma with a strong family history thickness. Then there are minor risk factors,
mostly so that you can check the offspring associations that may appear in some studies but not others or may be of minor clinical
for their risk.”
He added, though, that these instances rep- significance.
“These genetic factors so far from the GWAS
resent a tiny fraction of his clinic population.
“Even though I can do genetic testing at studies fall into the inconsistent or of minor
significance categories for most patients,” Dr.
no cost to my patients, I rarely do,” he said.
The other type of glaucoma gene, which iden- Alward said.
The DIY tests that are not currently availtifies risk factors instead of a high likelihood
that disease will develop, is usually found in able would usually find sequence variations
genome-wide association studies (GWAS). Many that are either meaningless or that would proof these genes have already been discovered, vide a tiny incremental risk that would not be
clinically significant. ■
and new ones are regularly added to the list.
These genes cause a very small, incremental
risk of developing disease but do not by themselves cause glaucoma. For now they are of
WALLACE L.M. ALWARD, MD
greater interest to glaucoma researchers than
P: 319/356-2228
E: wallace-alward@uiowa.edu
to individual patients, Dr. Alward said.
This article was adapted from Dr. Alward’s presentation during Glaucoma Subspecialty
The most important of these is LOXL1, which
Day at the 2014 meeting of the American Academy of Ophthalmology. Dr. Alward did
is associated with exfoliation glaucoma and
not report any relevant disclosures.
TAKE-HOME
IN DISPENSABLE
41
( In Brief )
Two-toned
colorations
Expanded vision values
Neon
yellow
Men’s
frames
Fashionforward
Why having a pulse on current eyewear trends is vital
to dispensary profitability, customer base
By Rose Schneider, Content Specialist, Ophthalmology Times
hen it comes to building
a contemporary inventory of eyewear in the
dispensary, maintaining a fashion-forward
optical shop is key to
sustaining profit flow,
according to Joy Gibb, ABOC.
“Customers are looking for what’s fresh
and new,” said Gibb, ABOC, president of Eyes
of Joy Mobile Optical Service, Woods Cross,
UT. “If all you have in your (frame) boards
are the same styles and colors that you did
when they bought their last pair, they will
quickly go somewhere else to buy something
different and fun.”
Fortunately, many resources are available
for eye-care professionals (ECPs) to keep their
dispensary inventory on top of the latest trends,
Gibb said.
The Vision Council, she explained, offers
several informative websites (Eyecessorize.
com and Eyecessorizeblog.com) as part of its
campaign to increase awareness of the fashion and lifestyle aspects of eyewear.
Continues on page 42 : Trending now
Photos courtesy of The Vision Council
W
Women’s
frames
Men’s
sunglasses
Women’s
sunglasses
ALCON UNVEILS POWERS,
CASE FOR CONTACT LENSES
F OR T WOR T H, T X :: ALCON Laboratories
has extended the line of AIR OPTIX COLORS
contact lenses to include plus-power lenses for
patients with hyperopia across the full range
of nine colors—ranging from subtle to vibrant.
“Patients are interested in [these] contact
lenses because of the range of colors available
and the comfortable wear they get,” said Carla
Mack, director of professional and clinical support, Alcon. “Our hyperopic patients have been
vocal about their desire to try the lenses, and
having plus powers available is a great way for
eye-care practitioners to re-engage with their
farsighted patients about color
contact lenses.”
Recommended for
daily wear and a monthly
replacement schedule,
these contact lenses are
available with an 8.6-mm
base curve and a 14.2mm diameter. The power
range now includes +6 D
to –6 D (0.25-D steps; including plano) and –6.50
D to –8 D (0.50-D steps).
The nine colors are:
Gray, Blue, Green, Pure
Hazel, Brown, Sterling Gray,
Brilliant Blue, Gemstone
(Photo courtesy of Alcon Laboratories)
Green, and Honey.
In other news, Alcon also has released to
the market a new, more consumer-friendly
contact lens case with marked packages of
CLEAR CARE Solution.
The new contact lens case is blue and white,
with lens baskets differing in color to help consumers more easily differentiate between left
and right lenses before and after cleaning.
Lens baskets in the new case now have tabs
to enable easier opening of the lens baskets.
“When it comes to contact lens care, we are
always trying to improve patient value, convenience, and compliance with our products,”
said Shawn Millerick, head of U.S. OTC marketing, Alcon. “We are pleased to be able to
provide a new contact lens case with enhancements to provide a more convenient experience, based on feedback from CLEAR CARE
Solution users.” ■
42
indispensable
TRENDING NOW
Fashion shows—such as at the Vision Expo
meetings—are also opportunities for all professionals across the eye-care spectrum to see
upcoming color schemes, materials, shapes,
and styles that will be hitting frame boards
in the near future, she noted.
Frame representatives are another excellent
resource to utilize, she said.
“They will see color palettes and designs that
will start to trend,” Gibb explained. “A good
representative will work closely with companies to have that information available to their
accounts as soon as they can.”
FR AME STYLES
PAT I E N T S W I L L WA N T
As for upcoming trends for this spring and
summer, Gibb offers this breakdown of styles
and colors every ECP should have in the optical dispensary:
From Shopper to Buyer: Tips for Making a Sale
In a well-stocked optical dispensary brimming with the latest
eyewear trends, perhaps what is most daunting is selling
the right frames to difficult, fashion-conscious patients. Joy
Gibb, ABOC, offers some practical pearls:
ASK A BOU T
PATIEN T LIFE ST Y LE .
T HINK ‘OU T
OF T HE BOX .’ Gibb
“I always ask patients a bit
about their lifestyle, (such
as) their work life and play
life,” Gibb said. “I ask what
they like or dislike about
their current frame style and
if they want to try something
a bit different from what
they are wearing. I always
try to have a few fashionforward, trend-settertype frames on my board
for those who are more
fashion-conscious.”
notes that her practice
is fairly conservative
and mainstream, so it is
important to have a few “outof-the-box” frames to pull. “I
also have those types of
frames for another reason,”
she said. “Sometimes you
have someone who has been
in a very conservative basic
frame—color, shape, etc.
They want to make a change
and more of a fashion
statement, but are really
looking for a professional
opinion and permission to
do so. If I can show them
an extreme difference from
where they are, it makes
them more comfortable to
at least go somewhere in the
middle and a little further
away from where they’ve
been in style.” FIND T HE PER FECT
M ATCH. “The other thing
to remember is sometimes
fashion-forward or trendy
frames don’t look as good
on the board as they do on a
face,” Gibb said. “They can be
intimidating with some of the
colors and shapes, but if you
get that frame on the right
person, it can look amazing!” ■
> WOMEN’S COLOR S: Feminine coral,
bright white, pastel mint green, glossy lavender,
rich maroon, and soft nude hues.
> WOMEN’S SH A PE S: Alluring cat-eyes, updated Clubmasters, geometric silhouettes, oversized aviators, funky squares, and streamlined
ovals.
> WOMEN’S DETA ILS: Crystal clear finishes, shimmery overlays, bold temple color
blocking, binocular-inspired accents, and angular
brow bars.
> MEN’S COLOR S: Neon yellow, matte black,
metallic taupe, elegant emerald, mauve gray, and
baby blue tones.
> MEN’S SH A PE S: Traditional aviators, sporty
squares and rectangles with flat-top browlines,
dapper rounds, and bucket profiles.
> MEN’S DETA ILS: Two-toned colorations,
pops of neon pigments, modernized aviator-like
bridges, colorful button embellishments, white
temples, and futuristic piping.
“Another hot color for both men and women
is Tokyo Tortoise,” Gibb said.
As for technology-infused eyewear, Syl Tang,
founder and president of HipGuide, New York,
said “wearables” continue to be popular with
patients.
“Companies are trying to figure out how
to integrate some of the technologies that can
be offered by Google or other tech companies
into eyewear, but that hasn't been sorted out
yet,” she said. “The actual Google Glass as it
first existed has been discontinued . . . but my
instinct is this isn’t for lack of interest, but an
indication of exploration into how that tech
could be worked into existing optical offerings. That said, it’s still a work in progress.”
Tang also highlighted several frame styles
that she believes are becoming more popular
this year.
“From a fashion standpoint, military frames
are at an all-time high interest level,” she said.
“Brands such as Oliver Peoples (http://oliverpeoples.com), which outfit shows such as ‘The
Blacklist,’ will see their military-inspired styles
do well. More importantly, brands with a true
military heritage, such as Randolph (http://
www.randolphusa.com), are going to be popular.
“We're also seeing a lot of racing-inspired
eyewear, (such as) frames which have a motoring feel are suitable for those situations,” Tang
continued. “On the feminine side, Swarovski's
sunglass range is extremely en vogue. They have
hit just the right balance of retro with modern
and it's in line with the color aesthetic for 2015,
especially what's coming down the runways.”
W H O D E C I D E S W H AT I S T R E N DY ?
Just why are these colors and styles popular
this year as opposed to others? The answer,
according to Gibb, is as simple as how overall
fashion changes with time.
“A good example was during the recent recession,” she said. “We went from frames with lots
of bling-type embellishments to very simple and
understated embellishments. Even if people had
money to spend, they didn’t want to look like
it. I think our trends change with the times.”
T HE PER FECT FASHION V ENDOR
Knowing what is trending now is only half the
battle, however, Gibb said.
Choosing the best vendor to stock an optical
shop’s inventory with the hottest fashionable
eyewear that patients will want to purchase
is also highly important, she said.
“You really have to know your demographics and what will do well in your area,” she
said. “There are always various levels and versions of ‘fashion frames’ in everyone’s lines.”
Gibb suggested keeping two important
thoughts in mind when vetting the ideal vendor:
> If you could not return the eyewear, would
you still buy it?
> Buy for the patient, not your own personal
eyewear wardrobe or preference.
Most importantly, Gibb urged, always remember to continue bringing new styles and
trends to the optical shop’s frame boards.
“It spruces them up, they don’t look the same
every time a customer comes in to your practice, and it keeps an air of enthusiasm and
excitement among the dispensers to have the
ability to pull new and exciting product for
customers,” she said. ■
43
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Ochsner Health System in New Orleans seeks a board certified, fellowship
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Ochsner Health System is southeast Louisiana’s largest non-profit, academic,
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multi-specialty, healthcare delivery system. Driven by a mission to Serve,
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care is provided across the region by Ochsner’s 13 owned, managed and
affiliated hospitals and more than 50 health centers. Ochsner is the only
Louisiana hospital recognized by 2014-15 U.S. News & World Report as a
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professionals, industry
Ochsner Health System and The University of Queensland Medical School
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indispensable
47
Use closing statements to turn
optical shoppers into buyers
Experiment to find the techniques that work best for customers, dispensary
Dispensing Solutions By Arthur De Gennaro
AS I MENTIONED in the
last installment in this series
(http://bit.ly/1AsAntC), an optician attempts to close a sale
using what is known as a closing statement. At its heart, a
closing statement is a technique
used to get the shopper to make
a purchase decision—that is, to
become a buyer.
A little Internet research will
show that there are literally
hundreds of closing statements.
The following are a couple of
my favorites. I use these all the
time when engaging customers.
sume you will want them in your
new eyeglasses as well.”
If the shopper has enjoyed
Transitions lenses in the past,
he or she may simply nod or
say, “Yes, I would like that.”
A LT ER NAT I V E CLOSE
The alternative close—sometimes called the alternative closing question—offers the shopper a choice or series of choices.
Should the shopper select one
of the choices it would indicate that he or she has made a
purchase decision because the
product consideration set has
ASSUMPTIVE CLOSE
been reduced to one. Examples
The assumptive close is used
of alternative-closing questions
when the seller notices buying
are:
> “Mrs. Arthur, that frame
signals from the shopper (which
looks great on you! Would you
has been discussed in a previous
prefer it in the gold, silver, or
article) and the optician is conbronze?”
vinced that he or she has estab> (After conducting the approlished sufficient trust and value.
priate demonstration.) “Which
In this case, the optician
would you prefer in your new
might say: “Mrs. Arthur that
eyeglasses, the thinner/lighter/
frame really enhances your apsafer polycarpearance and I
bonate lenses or
am sure you will
the conventional
love the new digIn the closing
plastic lenses?”
ital progressive
> “I can have
statement, the
lenses. If you will
optician uses one
new eyeglasses
have a seat at the
of any number
ready for you
dispensing table I
of techniques in
on Friday or a
will get the order
the hope that the
week from today.
started.”
customer agrees to
Which date do
Should the
make the purchase.
you prefer?”
shopper take a
As the examseat at the disples demonstrate,
pensing table, it
the alternative close can be used
would be an indication that he
to gain shopper approval of indior she has made the decision to
vidual products or for the entire
purchase.
purchase (lenses, frames, and
Another example of an asadd-ons). This is important as
sumptive close is: “Mrs. Arthur,
opticians generally obtain cusI see you have Transitions lenses
tomer acceptance as line-item
in your current eyeglasses. I as-
TAKE-HOME
approval for each product as it is
being demonstrated.
E X T R A-INFOR M AT ION
CLOSE
The extra-information close is
often used when a shopper appears indecisive. It is a powerful
tool for overcoming objections,
especially price objections.
The intent of the extra-information close is to provide the
shopper with an additional benefit or benefits he or she will receive by purchasing the product. The intent is to increase the
perceived value of the product(s)
offered in the shopper’s eyes. If
the shopper finds the benefits to
have value, this close could tip
the price/value scale in favor of
the buying decision.
A WORD TO THE WISE
As the old saying goes: “A word
to the wise is sufficient.” With
regard to closing, keep in mind
that closing techniques are used
only after the optician has skillfully opened the sale, completed
the interview, demonstrated
only appropriate products, established trust, established
value, and the shopper has exhibited buying signals.
If the optician attempts to
close the sale too early or has
not skillfully completed each of
the steps in the selling process,
it is likely that the shopper will
offer an objection. Worse still,
the shopper may feel that the
optician is pushy or to some degree incompetent.
PR ACTICE
MAKES PERFECT
An old joke goes like this: A
7 Steps
of a
Retail Sale
1. OPENING.
2. INTERVIEW.
3. DEMONSTRATION.
4. TRIAL CLOSE.
5. OVERCOMING OBJECTIONS.
6. CLOSING. The optician uses
one of any number of closing techniques. The customer agrees to
make the purchase.
7. MAINTAINING AN ONGOING
RELATIONSHIP.
tourist stops a policeman in
New York City and asks, “How
do I get to Carnegie Hall?”
The policeman responds,
“Practice, practice, practice.”
The corollary here is that just
like a concert musician, salespeople get to the top of their
game through focused and continual practice of their craft.
There is no substitute for this.
Fortunately, the opportunity
to practice presents itself each
time a customer enters the optical dispensary. ■
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.
48
practice management
Tears, drama not included:
How to restructure clinic staff
When someone you depend on quits and everyone wants the job, how do you fill the opening?
Putting It In View By Dianna E. Graves, COMT, BS Ed
“PERCEPTION: A way of regarding,
understanding, or interpreting something; a
mental impression.”
M
y definition of “perception” is:
“Reality as it pertains to you
and where you are in your life
right now. Not bounded by reality, truth, or acceptance of
facts present.”
Our clinic is in the middle of a forced restructure of the staff ladder to the perceived
top. My “right-hand man” is moving out of
state soon to be closer to family.
When these announcements occur, you
will naturally go through a grieving process with the obligatory steps of loss: anger,
questioning (why me?), despair, melancholy,
depression, and finally acceptance, which
eventually will allow you to move forward
again. Then, add the in-between steps of
panic, terror, and initial shock, and the circle will be complete. These steps often occur
at a rapid-fire rate and can take less than a
week to cycle through you and your clinic.
This is the manager’s reaction to a change
of this magnitude. Then multiply it by the
number of staff you have!
LETTING THE DUST SETTLE
After letting the dust settle, initiate a game
plan for the future. This involves a broad,
eyes-wide-open look at your clinic, at the
staff you have, and your doctors to determine who is going to be the next heir apparent for this position. How tumultuous will it
be bringing a new person into that role? The
big issue: You want a specific person in that
role, but they are running for the hills and
want nothing to do with moving forward!
After you find your next potential clinic
site lead, the next step is “buy in”—from the
physicians, the rest of the staff, management, and the other lead technicians.
Very often, there will be a trickle-down effect. “If I move Jane to this position, who can/
will take her current place in the clinic?”
Clinic D and she has turned into Attila the
At this point, I am in the process of
Hun!
changing leads and lead site locations in six
Everyone is towing the line, having to folof our eight clinic sites.
low the book to the letter, and it is a tense
Questions arise regarding every option:
clinic because she’s in a new role and is tryDo I move Sarah, who is running Clinic A
ing to prove that she can do
fantastically to Clinic D, and
it.
now move Amy into Clinic
And the new lead of Clinic
A, praying Amy will do an
When there is an
A? She wanted to stay in her
equally a great job? Do you
important position
old clinic, but said she would
court disaster by making this
needing to be
change and is now sullen
broad of a change?
filled, but every
and grumpy all day.
Sadly, the answer is often
staff member is
In this chaotic switch, we
“yes.”
gunning for the job,
are also adding a new lead,
Sarah—who is currently
how do you pick
and one of the current leads
running a one-doctor ofthe best without
is going into the float pool
fice and does a great job, but
hurting people’s
as she is cutting her hours.
is very underutilized therefeelings? Here are
While most of the staff pro—will now move to a busy
the 5 thoughts to
fesses their support for the
two-doctor office. It’s a step
remember before
new lead, the dinner bells for
up, and will test her strength.
making that decision.
the piranha in waiting have
She can do it, and will—once
begun ringing!
she comes out from hiding.
Wait a minute—simply
With initial game plan in
because she is a new lead, now the rest of
hand, next I need to present it to the docthe staff will treat her differently and they
tors for their reaction and buy in. It’s a
are not thrilled with her anymore even
sales-pitch effort, full of pronouncements
though they loved her before the upgrade?
of faith and support. After having achieved
Absolutely!
their buy in, the hardest part of the process
Why? Because of perception. The hardest
comes—telling the staff.
part of this whole process is that you probYou may be thinking: “Why is this so
ably will have angry staff, hurt staff, somehard?” Tell them the way it will be, answer
one may even get depressed or belligerent
minimal questions, then shut the book—
because you didn’t choose them as the next
case closed. It has been so decreed, now
lead.
move on.
Explaining your rationale will not be
Oh, for it to be so simple, because that’s
easy, because in their mind, you made the
not how a major change occurs in their
wrong choice and didn’t even give them a
world. Each staff person (including the docchance to a position they have the right to
tor) will view the change as it occurs to his
hold. Beware—you may even lose a staff
or her world.
person during this process.
Let’s return to Sarah, past lead of Clinic
Here are some thoughts to keep in mind:
A and now the new lead of Clinic D. Staff
loved going to Clinic A because Sarah was a
fun lead. Calm, relaxed, mellow—of course
NO ONE H AS THE R IGHT
she was! She only had one doctor to keep
TO A N Y POSITION SIMPLY
moving. She had minimal stress on most
BEC AUSE OF Y E A RS OF
days. Staff had plenty of free reigns, with
SERV ICE , AGE , DEGR EE , OR
minimal heartburn. Now she has fast-paced
TAKE-HOME
1
SA L A RY.
49
practice management
While I applaud tenure and education,
being a lead is not book-learned or the ability to survive in a group for years.
I can’t make a lead that has the traits of
empathy, sympathy, loyalty, and teamwork.
You either have these traits or you do not. In
order to be a lead you need these qualities
to ensure fairness and evenness when you
make decisions. Your decisions need to be
group-based, not elevating your personal position in the group.
DR A M A QUEENS , DOCTOR’S
PET, DI VAS , A ND
SCHMOOZERS NEED NOT
A PPLY.
2
I remind the staff over and over—it is not
about you! It is about your group at your
site.
Someone once asked me when I became
the manager for more than 50 people how
it felt to be “Number One,” “The Lead Dog.”
My response was: “What number one? I am
number 51—everyone is above me.” If I can
get them to all move together in one flow toward the eventual end of each day, including the doctors and patients, with minimal
uproar, I have done my job.” I repeat again—
it is not about you.
TAT TLING, BEGRUDGED
STA FF W HO FEEL THEY W ER E
BY PASSED W ILL BR ING THE
FAULTS OF CUR R EN T LE A DS TO
YOU AT THIS TIME IN A N EFFORT
TO PROV E THEY WOULD DO A
BET TER JOB TH A N THE CUR R EN T
SL ACK ER .
3
Listen to the criticism, and if the criticism
is valid, correct it immediately. Otherwise,
these are usually hit-and-run comments that
they do not want you to pass along. They
are hurt and lashing out.
4
BEWA R E OF ELEVATING
THE DOCTOR’S FAVOR ITE
TECHNICI A N.
The doctor may really want this to
happen, but it very often will cause a
great deal of resentment by the staff toward you (not the doctor) because they
will feel you caved in and didn’t protect
them from this change. The doctor may
be irritated if you do not place their person as a lead, but explain to them you
need to do what is right for the site and all
the doctors.
M A K E THE DECISION BASED
ON R E A LIT Y, THE FACTS AT
H A ND, A ND W H AT IS BEST
FOR THE CLINIC , A ND THEN
STA ND BY YOUR DECISION.
5
Be aware: reality means the staff will
need to face the facts from all sides, not the
perception of which they like the best and
what will benefit them most.
After the dust has settled, the leads and
staff are finally adapting, and there is some
semblance of normalcy again returning to
you at work, remember the following: this is
what you wanted, to be the lead dog.
Remember these famous words of wisdom from Suzanne Sugarbaker (from the TV
show “Designing Women”): “Life is like a
dogsled team—if you are not the lead dog, the
view never changes!”
There is a reward for doing the job you do
every day! ■
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
Page
Abbott Medical Optics
7
www.amo-inc.com
Alcon Laboratories Inc.
Page
Advertiser
Imprimis Pharmaceuticals
CV3
Rhein Medical
P: 858/704-4494
CV2, 3, 27, 33
P: 800/862-5266
www.alcon.com
Alimera Sciences
Advertiser
Maine Society of Eye Physicians
39
37
P: 914/345-7400
www.micromedinc.com
Allergan Inc.
17-18
P: 714/246-4500 or
800/433-8871 (Customer Service)
F: 714/246-4971
www.allergan.com
Omeros
20-21
www.omeros.com
9
P: 800/452-8567
www.glaukos.com
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15
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Glaukos
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P: 855/832-7522
www.tearlab.com
10A-D*
MicroMedical Devices
5
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P: 207/445-2260
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www.iluvien.com
Page
31
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50
Bacitracin Ophthalmic
Ointment USP
practice management
Rx Only
STERILE
DESCRIPTION: Each gram of ointment contains
500 units of Bacitracin in a low melting special
base containing White Petrolatum and Mineral Oil.
CLINICAL PHARMACOLOGY: The antibiotic,
Bacitracin, exerts a profound action against many
gram-positive pathogens, including the common
Streptococci and Staphylococci. It is also destructive
for certain gram-negative organisms. It is ineffective
against fungi.
INDICATIONS AND USAGE: For the treatment
of superficial ocular infections involving the
conjunctiva and/or cornea caused by Bacitracin
susceptible organisms.
CONTRAINDICATIONS: This product should not
be used in patients with a history of hypersensitivity
to Bacitracin.
PRECAUTIONS: Bacitracin ophthalmic ointment
should not be used in deep-seated ocular
infections or in those that are likely to become
systemic. The prolonged use of antibiotic containing
preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new
infections develop during treatment appropriate
antibiotic or chemotherapy should be instituted.
ADVERSE REACTIONS: Bacitracin has such a low
incidence of allergenicity that for all practical
purposes side reactions are practically non-existent.
However, if such reaction should occur, therapy
should be discontinued.
To report SUSPECTED ADVERSE REACTIONS,
contact Perrigo at 1-866-634-9120 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION: The ointment
should be applied directly into the conjunctival
sac 1 to 3 times daily. In blepharitis all scales
and crusts should be carefully removed and the
ointment then spread uniformly over the lid
margins. Patients should be instructed to take
appropriate measures to avoid gross contamination
of the ointment when applying the ointment
directly to the infected eye.
HOW SUPPLIED:
NDC 0574-4022-13 3 - 1 g sterile tamper evident
tubes with ophthalmic tip.
NDC 0574-4022-35 3.5 g (1/8 oz.) sterile tamper
evident tubes with ophthalmic tip.
Store at 20°-25°C (68°-77°F)
[see USP Controlled Room Temperature].
Manufactured For
®
Minneapolis, MN 55427
0S400 RC J1 Rev 08-13 A
Career decisions: Start,
buy, or join a practice?
By Keith Borglum, CHBC
IT'S NOT JUST physicians fresh out of residency or fellowship that face career decisions.
It can happen to anyone, anytime.
Some are early-career physicians who decide
they made a mistake in choosing an employer,
choosing a location in which to practice, or found
that the position they were planning on evaporated. Some always planned to work for someone else until they were more comfortable with
their clinical and business skills before setting
out on their own.
Some are mid-career doctors whose groups
break up, or are acquired by bigger group with
whom they find they disagree.
Even senior physicians sometimes find themselves in a situation where they have to make a
choice just a few years before retirement.
JOINING A PR ACTICE
Decide where you would like to practice, do a
little research on community need, then look
around for available options and support resources.
Taking employment by joining a practice is certainly the simplest solution, if a job is available.
There is a food of physicians taking this route
now in response to the Affordable Care Act, and
with the increasing burdens of administration.
On the other hand, I assist a regular stream
of physicians that have become unhappy with
their employer, and who are eager strike out on
their own or be able to control their own work
environment.
BU Y ING A PR ACTICE
It is less expensive to buy a practice at or below
fair market value (FMV) than to start your own;
but it is less expensive to start a practice from
scratch than to overpay for a purchase. These
scenarios compete with each other, and balance each other out financially, which is what
keeps FMV “fair.”
Buying a practice eliminates much of the hassle and expense of a start-up, provides a foundation of patients upon which to build, produces
quicker cash flow, and reduces marketing needs.
Drawbacks can include inheriting antiquated
systems in need of replacement, a dysfunctional
staff, and perhaps a poor clinical reputation.
Sometimes the seller’s spouse was the office
manager, and management walks out the door
with the seller. (Sometimes, that’s a good thing.)
LOCATION, LOCATION
The best place to practice is where you want to
spend the rest of your life outside of practice—
when you leave the office at the end of the day
you should be where you want to live.
Even those locations that might be considered grossly over-doctored will probably have a
niche community opportunity within less than
an hour’s drive. All the research says that money
only buys happiness up to around $50,000 per
year—“enough to cover basic necessities”—then
it has no further impact. So look beyond the
potential practice income in selecting a career
situation.
WHEN TO TAKE A RISK
There are many creative ways to have a professional career.
If you grew up in Florida and have always
had an interest in Alaska, take employment for
a year before investing in a start-up.
I had a client who, for more than a decade,
alternated practice every 2 weeks between rural
New York State and a Caribbean island, and was
quite happy with it until a hurricane eliminated
the southern office. He sold the northern practice to a buyer wanting to be near aging parents.
I’ve known several physicians who fly to work,
either on commercial airlines or in their own
airplanes.
If you want more tangible evidence to support
your choice of locale, it is easy—and more accurate—to do your own research of community
needs rather than buying a demographic survey.
Pose as needing a simple evaluation in your
specialty for a teenager or parent, and call around
to the majority of medical offices in your specialty to find out the wait for a new appointment.
If the only physician in town has a 2-week
wait, then adding one would theoretically result
in two physicians having a 1-week wait, both
still being full. If all three physicians in a community each have a 4-week wait, then there is
room for six to nine additional physicians. Your
wait times will probably equal the others within
weeks or months.
Private consultants, most of whom are members of the National Society of Certified Healthcare Business Consultants (NSCHBC.com), can
also offer personalized guidance and support
to your endeavor. ■
KEEP IT SIMPLE
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SUPPLEMENT TO
AND
EXAMINING PEDIATRIC EYES
CLINICAL PEARLS FOR HELPING YOUR SMALLEST PATIENTS
1
2
Figures 1 and 2. The author using his hands to physically simulate the directions of
eso-deviations and exo-deviations to help parents better understand.
By Alex Christoff, BS, CO, COT
he common eye problems
found in adults, developing
over decades of life as acquired
disease, are different in
children. There is an old pediatrics adage
that “children are not little adults.” This is
certainly true when it comes to the pediatric eye exam that many allied health care
personnel find themselves facing, often
with dread, on a weekly or daily basis.
Obtaining pertinent history—often
from a source other than the patient—and
relevant clinical information to help the
physician arrive at the proper diagnosis
and provide the appropriate treatment,
requires a different and creative approach,
T
volume 04 | issue 1 | spring 2015
patience, and talent. Technical staff who
themselves are parents have a distinct
advantage: they are familiar with the
nuances of behavior in young children.
They know the various developmental
milestones, when children start to sit up,
stand, learn to walk, and start talking.
These milestones are an important part
of the pediatric history and often play an
equally important role in illuminating and
the underlying cause of clinical signs and
symptoms.
The pediatric eye exam can be broken
down into five basic components:
■ History and chief complaint
■ Sensorimotor evaluation
■ Visual acuity testing
■ External exam and pupillary evaluation
Instillation of dilating eye drops.
We will conclude with a brief review of
the more common causes of decreased
vision in infancy.
■
Preliminaries of an exam
The pediatric eye screening begins by
observing the child at ease, first in the
waiting area as you walk out to call and
greet him, then as he walks in to the exam
room with you. Introduce yourself. Offer a
handshake to adults and older children. Be
cognizant of the fact that some cultures
and religions do not shake hands. You
should become familiar with your patient
demographic and apply these concepts
accordingly. Comment to a child about
See Pediatrics on Page 3
1
3
I N F O . I N S P I R AT I O N . C O M M U N I T Y.
Pediatrics
Continued from page 1
clothes, toys, what they’re eating,
siblings, etc.
As you enter the exam room,
have the children and their
families take seats away from the
exam chair if possible, guarding
exam-chair time as a precious
commodity. Once the child is
seated in the exam chair, her
attention timer is ticking. If you
approach the interview and this
initial part of the exam with dread,
children will sense your tension
and become uncomfortable. It is
incumbent on you as the examiner
to gain the child’s confidence and
trust, and you will want to do so
in a relaxed, open, honest, and
playfully engaging way.
Once the child is seated in the
exam chair, you should establish
and maintain eye contact. Sit at the
child’s eye level by lowering your
chair/exam stool and/or raising
the child’s exam chair. Maintaining
eye contact may or may not be
possible with autistic children
who often avoid eye contact
with others. You will want to
initiate verbal rapport with simple
questions comments, such as,
“How old are you?” Over-estimate
age and grade level. Ask about
siblings who came with her to the
appointment today. These quick
simple pearls warm the experience
for the child and her family, and for
you as the examiner.
It is important to remember
that as you work with children
you have to focus your exam.
Check what you need early on
while you have cooperation, and
save the more difficult tasks for
last. You will have to develop a
different vocabulary. For example,
say “magic sunglasses” when
introducing the anaglyphic glasses
of the Worth 4-Dot test and the
Spring 2015
iTech
Components of a pediatric eye exam
■
History and chief complaint
■
Sensorimotor evaluation
■
Visual acuity testing
■
External exam and pupillary evaluation
■
Instillation of dilating eye drops.
polarized glasses of the various
stereo acuity tests. Use “special
flashlight” to describe your
retinoscope, and “funny hat” or
“coal miner’s hat” when describing
what the physician will do with
the indirect ophthalmoscope.
“Magnifying glass” is an apt
description of the magnifying
lens used with the indirect
ophthalmoscope, and suggest
“let’s ride the motorcycle/bicycle”
when it is necessary to do a slit
lamp exam.
Taking a history
“When all else fails, take a history.”
These words were the sage advice
of J. Lawton Smith, MD. Former
ophthalmology resident at the
Wilmer Eye Institute in the 1950s,
Dr. Smith went on to become an
internationally recognized neuroophthalmologist at the Bascom
Palmer Eye Institute in Miami.
All medical histories should
begin by identifying the patient’s
chief complaint, preferably in as
close to their own words as the
electronic medical records of the
present day may allow. Examples
of a chief complaint include,
“decreased vision,” “headaches,”
“blurred vision,” or “double vision.”
The clinician will next want to
evaluate the history of present
illness, or HPI. For the parents, ask
who referred the child in to your
office and why. Sometimes the
simple question, “What can we
do for you today?” works best. Try
to establish when the problem
started (onset), how often the
problem is noticeable (frequency/
severity) and when the symptoms
manifest do themselves, how long
do they last (duration).
Who notices? Relatives,
teachers, the pediatrician?
Sometimes you can ask the child
simple question like, “Which eye
hurts?” or “Which is the bad eye?”
But avoid complex topics like
questions about double vision in
younger children because this is a
difficult concept at best for most
preschoolers.
Expand your history with
questions about treatment and
what has been done to address
the problem. Was a more extensive
workup required that might have
included blood work or imaging
studies? And how has the problem
developed or changed in the
interim between the last office visit
and the most recent visit? Do the
parents know anything about the
problem? This is the Internet age,
and most parents have explored
their child’s eye problem online
before having sought treatment.
With the HPI, you are trying to
develop a differential diagnosis—
basically, a short list of possible
causes by defining the problem
and making sense of the history. Of
course you will want to explore the
symptoms and signs observed by
the parents. Are they constant, or
Check what
you need
early on while
you have
cooperation,
and save the
more difficult
tasks for last.
4
intermittent? When do they occur?
What time of day? Are they worse
at the end of day, or with fatigue?
Failed vision screening
history. Children often present to
the pediatric eyecare practitioner
because they failed a vision
screening at school or at their
pediatrician’s office. It is very
important for the technician to ask
when the child was tested. There
are obvious clinical implications
and expectations if the failed
screening was six months ago vs. a
few weeks ago.
What was wrong? What part
of the screening test did they fail?
Was it because of an observed
misalignment? Did she do poorly
on the visual acuity test? How was
vision measured? Was it an ageappropriate test? Did the screener
use letters, numbers, pictures, and
isolated, linear, or single-surround
optotypes? As you will learn in
the pages that follow, all of these
elements factor in to how young
children perform on visual acuity
tests. In other words, a failed vision
screening may or may not really be
indicative of a real problem.
Strabismus history. When
it comes to strabismus, parents
will often use the term “lazy
eye” to mean strabismus and/
or amblyopia, the decreased
best-corrected visual acuity
often associated with strabismus.
Similarly, many parents use the
word “crossing” to refer to any
type of strabismus; esotropia,
exotropia, even in describing
vertical deviations. All of which
means the technician will have to
verify the direction of the observed
misalignment graphically with the
parents in order to make sense of
the history.
I use my hands to physically
simulate esotropia, or in-crossing
of the eyes by pointing to my
nose with both hands. Similarly
with a suspected exo-deviation,
I use both hands to point out
away from my ears to simulate
an outward drifting of the eyes
(Figures 1 and 2). Explore possible
strabismus more in your history
by asking which eye is seen to be
misaligned. Do the parents notice
any squinting? Bilateral squinting
is typically a sign of uncorrected
refractive error or ocular allergy,
while unilateral squinting is often
associated with strabismus. Ask
about eye rubbing. Does the
Children often
present to the
pediatric eyecare
practitioner because
they failed a vision
screening at school or
at their pediatrician’s
office.
child always rub the same eye?
Who notices? Is it the parents, the
pediatrician, the child’s teachers,
other family members? Is eye
misalignment visible in family
photos? Is it constant, intermittent?
Is it happening at distance fixation,
with daydreaming, or at near
fixation, when the child attempts
to focus?
Diplopia history. Double
vision occurs when one fovea is
not directed at the same object
of regard as the other. While this
is quite common in older patients
with an acquired strabismus, it is
uncommon in young children with
an early-onset misalignment who
develop suppression, or the ability
to “turn off” the image from the
deviating eye. This phenomenon
occurs at the level of the brain’s
cerebral cortex. So double vision
in a pediatric patient, if it is real,
implies an acquired etiology and
may require special laboratory
tests or neuro-imaging studies
like MRI or a CT scan to explore a
possible neurological cause.
When interviewing patients
of any age with a complaint of
double vision, one of the first
questions the clinician should ask:
“Does the double vision go away
if you cover either eye?” Binocular
diplopia resolves with unilateral
occlusion, while monocular
diplopia, diplopia still present after
covering one eye and most often
due to refractive error, resolves in
almost all cases with a pinhole. You
should also ask the patient if the
double vision is worse in certain
positions of gaze, at a certain time
of day, or at rest.
Pregnancy and birth
history. Children who were
born prematurely have been
shown to have a substantially
higher incidence of strabismus,
amblyopia, and high refractive
errors compared to full term
controls.1 So for these reasons,
you will want to ask questions
about the pregnancy, birth, and
developmental history of all
pediatric patients.
For the pregnancy, you should
ask the mother or parents about
illicit drug use, consumption of
alcoholic beverages, whether
there was a problem with preterm
labor, maternal age, paternal age,
prematurity (a full-term delivery is
40 weeks), low birth weight, use
of supplemental oxygen, presence
of retinopathy of prematurity and
whether it regressed/resolved on
its own or if it required laser photoablation, whether it was a normal
spontaneous vaginal delivery
(NSVD) or caesarean section, and
whether this was planned or
unplanned, and whether there
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were any labor complication.
Continue with questions about
birth complications, whether
there was an anoxic event/loss of
oxygen/delayed breathing, or any
breathing problems. You should
inquire as to whether there was
any trauma/instruments used
during the delivery (forceps,
suction), or any history of intracranial hemorrhage, convulsions,
seizures, or known syndromes.
defects and syndromes, and other
health problems become more
common in these situations. If
you are employed in one of these
facilities, you need to come to
terms with the various ophthalmic
sequelae and the medications
associated with them so you know
what to ask if and when these
children present to your clinic.
Because these kids tend to have
a team of healthcare providers,
The sensorimotor examination is
the key element. The problems that bring
children in can impact ocular alignment,
depth perception, and sensory fusion.
Developmental history.
Technicians who are parents
have a decided advantage here
because they are familiar with the
developmental milestones of their
own children. But there are a few
developmental milestones that
all technicians can easily learn to
help shed light on the observed
ophthalmic eye findings as they
may contribute to a final diagnosis.
You should ask if the child has
met all of his or her milestones
to date. Familiarize yourself with
some of the basic components
of pediatric developmental
milestones, available online at the
website of the American Academy
of Pediatrics.2
Past medical history. Most
children are very healthy and take
few, if any, medications. However,
this may not be the case for
children seen in a tertiary care
facility or a hospital that is part of
a large inner city medical training
center. Conditions associated
with prematurity like retinopathy
of prematurity, hydrocephalus,
seizure disorders, anomalous birth
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the past medical histories and
medications are often, but not
always, well documented in the
medical record.
Family history. Asking about
the family history for pediatric
patients is not only good
medicine, it is now mandated
by the federal government
as part of its Meaningful Use
criteria for affective utilization
of the information obtained by
ophthalmologists in the electronic
medical record, or EMR. Questions
about other individuals with
strabismus, nystagmus, amblyopia,
or history of early-childhood
patching or glasses should be
routine. Additionally, individuals
with childhood blindness,
glaucoma, cataract, or heritable
diseases should be documented in
the EMR.
Social history. Lastly, it is
also important to know the living
conditions at home because social
stressors like divorce, abuse, foster
parents, and institutionalization
due to developmental delay may
have implications for compliance
with prescribed glasses, patching,
use of eye drops, and attendance
at follow-up examinations. Ask
about who lives with the child,
especially if he is accompanied
by only one parent, grandparent,
older sibling, aunt, or uncle. Is
there smoking in the house? Are
the parents married, separated,
or divorced? Are there pets in or
around the house?
Pediatric sensory motor
examination
The sensorimotor examination is
the key element in the pediatric
eye screening. The problems
that bring children in to see the
pediatric eyecare professional
include a number of different
types of strabismus, vergence
abnormalities, amblyopia, and
refractive dilemmas, all of which
can impact ocular alignment,
depth perception, and sensory
fusion. The examination typically
starts by assessing (sensory) fusion
first and then measuring (motor)
alignment by prism and alternate
cover testing, both typically
performed by a trained specialist.
Sensory testing. Assessing
sensory fusion begins by
measuring gross binocular fusion
potential with the Worth 4-Dot
Test, which uses red/green
anaglyph glasses and a special
flashlight that displays four
lights—two green, one red, one
white. Convention dictates that
the patients wear the glasses with
the red lens over the right eye, if
there is a choice. The flashlight is
then shown to the patient at both
distance and near fixation, and she
is asked to report how many lights
are seen with both eyes open.
The response for binocular fusion
is four lights seen, in any color
arrangement. The response for
suppression is only one color seen,
either only two lights (red) for
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6
suppression of the left eye or only
three lights (green) for suppression
of the right eye. A response of
five lights seen is consistent with
diplopia or manifest strabismus.
Interpreting the results of the
Worth 4-Dot test should be done
with caution because the test
is dissociating, meaning it may
cause an otherwise controlled
or intermittent strabismus or
phoria to manifest itself as a tropic
deviation behind the darkened
anaglyph glasses. Children from
age 3 to less than 5 years of age
can be asked to just count the
lights on the flashlight by touching
them one at a time, usually just at
near fixation (Figure 3).
3
correspond to increasingly fine
stereo images—the more circles
that are seen, the finer the stereo
acuity, and the better the visual
acuity in each eye. We use the
animal figures only for preschool
children. Many of these tests come
in pediatric versions as well, which
can enhance cooperation.
Measuring strabismus. In
assessing strabismus, there are
basically two ways to quantify
ocular misalignment. The prism
and alternate cover test utilizes
either bar and/or loose prisms and
some type of opaque occluder.
Often a child will not allow you to
approach him with an occluder,
so your hand, palm, or thumb,
Figure 3.
Ask younger
children to count
lights on the
flashlight when
using the Worth
4-Dot Test.
Near stereo acuity testing
assess fine sensory fusion ability,
requiring clear and equal acuity
in both eyes and finer motor
alignment than what is required
by the Worth 4-Dot test. There
are a number of near stereo tests
available, though the industry
standards are typically the Titmus
or Randot stereo tests from Stereo
Optical. In each test, the wings
of the fly are the most disparate
and easily perceived, even by
children as young as 2.5 or 3
years of age. The circles of the test
though not preferable, will have
to do (Figure 4). Corneal light
reflex estimating techniques are
based on the observed position
of a corneal light reflex in relation
to the patient’s pupil in the
misaligned eye. These will be
discussed below. But let’s first talk
about the basic type of strabismus
seen in the pediatric clinic.
When strabismus does present
itself, there are four types of
deviations with which the clinician
needs to become familiar. An
esotropia is an eye that deviates
in toward the nose, with a corneal
light reflex temporal to the center
of the pupil. An exotropia is an
eye that deviates out away from
the nose, with a corneal light
reflex nasal to the center of the
pupil. A hypertropia is an eye that
deviates up with a corneal light
reflex inferior to the center of the
pupil. And a hypotropia is an eye
that deviates down with a corneal
light reflex superior to the center
of the pupil. The term orthophoria
or orthotropia means that the eyes
appear straight with corneal light
reflexes centered in both pupils
or by alternate prism and cover
testing.
Clinicians who routinely
perform sensorimotor evaluations
on younger children have to
find creative ways to maintain
the child’s interest. For distance
measurements, animated toys
and projected movies work well.
A parent or coworker can also
assist by standing at the end of
the exam lane, holding a flashing
toy, and calling the child’s name.
For near measurements, young
children are asked to sit on a family
member’s lap. The child usually
feels more secure there, and the
family member can then be asked
to hold a fixation stick or toy on
the examiner’s nose, leaving both
hands free to hold an occluder or
prism bar. Unfortunately, it is not
the scope of this article to discuss
the specific details of how to
perform the prism and cover test.
The take-home message is that
children tend to respond favorably
to animal puppets and toys, and of
interest, there seems to be some
science to support why.3
Despite our best efforts to
engage the patient, there will
times when a frightened or
uncooperative child will not
permit sensory testing or a prism
and alternate cover test. Other
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times, a patient may have such
poor vision in one eye, that she
is unable to fixate well enough
to be measured with prism and
alternate cover testing. In these
circumstances, the clinician can use
a number of corneal light reflex
tests to estimate and quantify the
observed strabismus.
To perform the Hirschberg
test, simply shine a bright penlight
or fixation light at the patient
from a distance of about arm’s
length. Observe the position of
the corneal light reflexes from
the flashlight in each eye of the
patient. They should be centered
in each pupil if the eyes are
straight. However, if the light
reflex is displaced near the pupil
margin in one eye, this represents
an approximate deviation of 15
degrees or 30.00 prism diopters
(PD). If the light reflex in one
eye is displaced mid-iris, this
represents 30 degrees or 60.00 PD
of misalignment. And if the corneal
light reflex in one eye is displaced
at the limbus, this represents
approximately 45 degrees or 90.00
PD of misalignment. It is up to the
examiner to identify the proper
type of strabismus or direction
of misalignment, but temporally
displaced corneal light reflexes
correspond to eso-deviations,
medially displaced light reflexes to
exo-deviations, inferiorly displaced
light reflexes to hyper-deviations,
and superiorly displaced reflexes
to hypo-deviations.
To estimate strabismus by
the modified Krimsky test, the
examiner uses loose or bar prism
to eventually center the displaced
corneal light reflex in the deviating
by trial and error, placing the
appropriate prism over the nondeviating eye.
Abnormal head postures.
Children sometimes develop an
abnormal head posture called
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torticollis (Figure 5), and their
families are asked by the child’s
pediatrician to have the patient
evaluated by a pediatric eye-care
specialist to determine if the
head position is being driven
by strabismus or some other
abnormality of binocular vision.
The strabismus measurements
required to diagnosis an ocular
abnormality in this situation are
not always possible in younger
children. But one of the quickest
and easiest ways to rule out an
abnormality of binocular vision is
to do a patch test. Simply place a
patch over one of the child’s eyes
and observe for 60 to 90 seconds,
asking the parents to restrain the
child’s arms if necessary to prevent
her from removing the patch. If
the head posture improves, this is
suggestive of an underlying ocular
abnormality of binocular vision
and requires further assessment
and more detailed measurements.
If the torticollis does not improve,
this is suggestive of a nonocular, perhaps musculoskeletal
abnormality, most often of the
sternocleidomastoid muscle on
the side of the neck toward the
head tilt.
Assessing visual acuity
in children
Birth to 2 to 3 months. If
the clinician is going to try
to measure vision in young
children, it’s important to first
have an understanding of what
is considered normal, or age
appropriate visual acuity in the
pediatric population. Is a baby
born with 20/20 acuity? Not at all.
Birch and coworkers estimated,
through preferential looking
techniques, that vision at birth
is somewhere around 20/600,
developing rapidly in the first
year of life and improving to
approximately 20/60 by 12 months
of age, and reaching an adult
normal of 20/20 by 60 months or 5
years of age.4
Newborn children are by
definition visually inattentive and
immature. They will, however,
blink to a bright light shown close
to their eyes. Their eyes will also
pop open suddenly when the
room lights are flashed on and off,
a reflex some clinicians call eye
popping, which tends to disappear
by around 6 months of age. Some
children will also respond with
saccadic eye movements to the
rotating stripes of the optokinetic
drum. This is just about all you can
expect from a neonate in his first
several weeks of life.
Intermittent strabismus may
also be observed, but it should
not be present by 2 to 3 months
of age, correcting for prematurity.
Pupils become active, and
accommodation begins by 2
to 3 months of gestational age,
which you can demonstrate by
showing the child a target that
stimulates accommodation, the
multi-colored lights of the Worth
4-Dot flashlight, for example, and
observing the constriction of the
child’s pupils. Mid-dilated pupils
sluggishly responsive to light by
this age predicts reduced visual
acuity for age. Nystagmus in this
age group suggests abnormality
of the anterior visual pathway,
while the absence of nystagmus
in an otherwise visually inattentive
neonate is suggestive of cortical
visual impairment, or impairment
at the level of the brain.
3 to 6 months. As children
approach 6 months of age,
they become extremely visually
attentive in the near range,
preferring faces over objects and
toys. They will sit on their parents’
laps and stare at you with an
astounding aplomb. Acuity can be
assessed for this age group in a
7
8
4
5
Figure 5.
Abnormal
head posture
called torticollis
may indicate
strabismus or
some other
abnormality of
binocular vision
or a non-ocular
cause.
Figure 4. Often a child will not allow you to
approach him with an occluder, so your hand,
palm, or thumb, though not preferable, will
have to do.
6
7
Figure 7.
Demonstration of
the “blink them
in” technique for
administering
dilating eye drops
in children.
Figure 6. Occluding can sometimes be a
challenge. The author recommends special
occlusive glasses designed for visual acuity
testing in children.
number of ways, including forced
recognition grated acuity tests
like Teller Acuity Cards (Stereo
Optical) and by observing how
they fixate on and follow silent
flashing targets, like a flashing toy
star, through a smooth pursuit
with each eye. This is typically an
abduction movement out toward
the ear followed by adduction
back again toward the nose,
without losing fixation. Repeat if
necessary. Last, but certainly not
least, if all else fails, they can fixate
on and follow the examiner’s face
through the same smooth pursuit
movements!
One can also take advantage
of the vestibular ocular reflex to
assess the visual pathways by
taking the child (make sure you ask
for permission from the parents!)
and holding her up in front of
you at eye level, face toward you,
spinning around gently in one
direction on a rotating stool. This
motion stimulates optokinetic
nystagmus (OKN) through the
inner ear. What you will see is the
child doing a smooth pursuit in
the opposite direction of the spin
as she watches the environment
rotating by behind you, then a fast
saccade back in the direction of
the spin, repeated over and over
again until you stop spinning. At
this point, a child with intact visual
acuity may exhibit a beat or two
of residual OKN, dampening in less
than 5 seconds. But in a child with
decreased or absent visual acuity,
the OKN will not dampen and
persist for more than 5 seconds.
6 to 36 months. Preverbal
children from 6 to 24 months of
age can be presented with a base
down prism in front of one eye,
typically 16.00 or 18.00 PD. With
both eyes open, this creates a
vertically diplopic second image
of a target at distance or near
fixation. This is called the induced
tropia test.5 If vision is intact,
and the child is not suppressing
visual input from the eye behind
the prism, you will see a vertical,
hypertropic shift in both eyes as
the child attempts to fixate on
the second image that appears
above the original fixation object
of interest. Absence of induced
vertical shift is suggestive of
amblyopia in the eye behind the
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Spring 2015
prism. This can be documented
in the chart as C for central (the
eye is straight), S for steady (no
nystagmus), and M for maintained
(fixation through the prism), or
CSM. If fixation is not maintained
for more than one to two seconds,
you would document this as
CSUM, for Central, Steady, UnMaintained.
After age 3: Recognition
visual acuity. Testing recognizable
optotypes, whether Allen or Lea
symbols, HOTV or Snellen letters,
can begin from 30 to 36 months,
depending on the cognitive ability
and cooperation of each child. The
author’s personal bias, based on
15 years of clinical experience, is
not to attempt recognition acuity
before 36 months due to variability
of maturity. Of course there are
always exceptions to every rule.
This age group will also peak
during the test, so occlusion of
the untested eye needs to be with
a tape patch or special occlusive
glasses designed for visual acuity
testing in children (Figure 6), or
adhesive tape directly over the
child’s eye, or on the lens of his
glasses. Single surround bars, also
called crowding bars, expedite
testing in the younger children and
have been shown to accurately
replicate the resolution challenge
of linear optotypes in amblyopic
patients while minimizing test time
in our most inattentive patients.6
You can help the child stay
engaged by turning the matching
card to the blank side and
advancing to the next letter. Point
at the screen and ask the child to
look at the screen, then flip the
card over to show the choices and
ask the child to match the shape
she sees.
From age 4, HOTV crowded
optotypes can be used with good
reliability, though every child is
developmentally different, and
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sometimes the examiner has to
resort back to a matching version
of the test. Most children will
progress to full Snellen recognition
optotypes by age 5, though I tend
to minimize the attention required
with linear Snellen acuity testing
by using the single surround,
crowded optotypes until age 10,
again, depending on the child,
maturity, and intellectual abilities.
Checking pupils
An important part of any complete
eye exam, this component of the
encounter, while straightforward
in adults, can be challenging
in inattentive children. A direct
ophthalmoscope is often helpful if
you have a less than cooperative
child because you can illuminate
the pupils from a more remote
distance and see a red reflex in
addition to the corneal reflexes
of the Hirschberg test. This is
also very useful in patients with
dark irides, as it makes the iridopupillary border a lot easier to see,
especially for those of us who are
presbyopic!
Giving eye drops
The last step in the pediatric eye
exam is arguably one of the most
stressful. here are a few techniques
that will foster cooperation, help
minimize stress, and overall make
the process of instilling eye drops
less tumultuous for the patient, his
family, and you as the examiner.
My favorite technique is the
“blink them in” technique. I explain
to the child that we need to put
eye drops in her eyes. I then direct
her attention to a playful sticker
attached to the ceiling above her
head. I ask her to tilt her head
back, then close her eyes, which
is exactly opposite of what she is
expecting you to say. “Close your
eyes tight, and I’m going to put the
cold water on your eye lashes,” I
tell her. This seems to be accepted
by most children. “And when I
count to three, we’re going to do
a big blink, really fast.” I give her
a tissue and tell her that she can
wipe after she blinks. I also gently
hold the child’s chin up until she
blinks to avoid the drops streaming
off her face and into her lap (Figure
7). I explain to the parents that
while this is a messy technique
(drops run all over the place,
usually on the child’s clothes), it
really works. Give it a try.
Another technique is the
“kangaroo pouch” technique in
which you cajole the child into
looking up in a similar manner
and at a similar target as described
above, then place the drops in
cul-de-sac of his lower lids. The
lower lid cul-de-sac is much less
sensitive, and a great place to
instill an eye drop. I don’t have as
much use with this technique in
the younger children, but it does
work well with older children and
teenagers.
Despite these techniques
some children, especially infants
and toddlers younger than 36
months of age, will not cooperate
with instillation of drops. In these
cases, it is necessary to restrain
the child in order to properly instill
the drops. In doing so, you will
first want to explain to the child’s
parents why you have to restrain
the child. Once parents agree,
small babies and very young
children can be placed on their
backs on the right arm of one
parent seated in the exam chair,
the child’s head toward the crook
of the parent’s elbow, feet across
the parent’s lap. Have the parent
hold the arms while you take care
of the head, lids, and instilling
drops. In older children, or bigger,
stronger kids who require restraint,
there is a real risk of injury to the
parent, the child, or even you as
9
10
Alex Christoff is
assistant professor
of ophthalmology
at The Wilmer Eye
Institute at Johns
Hopkins Hospital
in Baltimore.
E-mail him at
achris15@jhmi.edu
the examiner. A different technique
is recommended for these kids.
Have the child straddle the
parent’s lap facing toward the
parent, with one leg on either side
of the parent’s hips. Seat yourself
directly in front of the parent’s
knees, ask the parent to lean the
child backward onto your lap so
that he is prone on his back on
your legs and his head is in your
lap, facing the ceiling. You can
now ask the parent to restrain the
child’s arms and hands with their
hands, the legs are immobilized
around the parent’s hips, and you
have both hands free to restrain
the head, manipulate the lids, and
instill the drops.
Lastly, it is extremely important
for the technician to control the
dosing of dilating drops instilled
in the eyes of young children
because these medications can be
toxic,7 trigger seizures,8 and even
lead to cardiac arrest9 in neonates
and small children.
For newborn babies and
children younger than 6 months
of age, one drop of cyclomydril
(Alcon), which consists of
cyclopentolate hydrochloride 0.2%
and phenylephrine hydrochloride
1%, is my drop of choice. In
children with darkly pigmented
irides, I add an additional drop
of tropicamide 1% because it is a
better midriatic drop, though on
its own, a poor cycloplegic agent.
Starting at age 6 months
and progressing to age 16, instill
cyclopentolate 1% drops in
lighter-pigmented eyes, adding
tropicamide 1% or phenylephrine
2.5% drops for more darkly
pigmented eyes. Some children
who have had laser photo-ablative
surgery for threshold retinopathy
of prematurity may require all
three drops to dilate adequately
enough for the physician to see
into the eye.
Causes of decreased vision in
infancy
The causes of decreased vision in
children, in addition to amblyopia
and refractive error, include
developmental malformations and
acquired lesions of eyes and visual
pathways. Clinical markers and
signs include the oculo-digital sign,
a habitual pressing on one or both
eyes by the child with their finger
or fist. This behavior is specific to
bilateral congenital or early-onset
blindness due to retinal diseases
and heritable retinal dystrophies,
predicting best-corrected visual
acuity usually 20/200 or less in the
affected eye. Index of suspicion
should be high in children greater
than 6 months who do not readily
make eye contact with you.
Congenital nystagmus is
commonly seen in disorders
of the anterior pathways, such
as ocular cutaneous albinism,
which involves the optic nerves.
Look for a compensatory head
posture, implying optimal acuity,
binocularity, and functional vision.
Nystagmus is typically absent in
cortical visual impairment (CVI).
Large, slow, roving nystagmus
or eye movements are often
associated with poor vision and/
or visual loss before the age of
6 months. These types of eye
movements are not seen in CVI.10
End on a happy note
There are many challenges
associated with examining children
in the eye clinic. Indeed, it is one
part science, two parts art, and
mastering the required skills takes
skill, patience, practice, having the
right tools, and perhaps above
all, having the right attitude. After
a challenging session with any
child, end on a high note and
reward her for a job well done,
after making sure that is fine with
her parents, with a lollipop, or a
playful sticker she can wear out of
the office when she leaves. Treat
your pediatric patients the way
you would want someone to treat
your child, or you, for that matter.
Use dignity, empathy, and respect,
and they and their families will
remember you for it.◗
References
1. Kushner, BJ. (1982). Strabismus and
amblyopia associated with regressed retinopathy of prematurity. Arch Ophthalmol. 1982
Feb;100(2):256-61. 2. Hagan JF, Shaw JS, Duncan P, et al. 2008.
Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Third
Edition. Pocket Guide. Elk Grove Village, IL:
American Academy of Pediatrics. Available
at http://brightfutures.aap.org/pdfs/bf3%20
pocket%20guide_final.pdf. Accessed 2/18/15.
3. Mormann FA, Dubois J, Kornblith S, et al. A
category-specific response to animals in the
right human amygdala. Nat Neurosci. 2011
Aug 28;14(10);1247-9. 4. Birch EE. Visual acuity testing in infants
and young children. Ophthalmol Clin North
Am. 1989;2:369-89.
5. Frank JW. The clinical usefulness of the
induced tropia test for amblyopia. Am Orthopt
J. 33(1983):60-9.
6. Peskin MA. Threshold visual acuity testing
of preschool children using the crowded
HOTV and Lea Symbols acuity tests. J AAPOS. 2003;7(6):396–9.
7. Adcock EW 3rd. Cyclopentolate (Cyclogyl)
toxicity in pediatric patients. J Pediatr. 1971
Jul;79(1):127-9.
8. Demayo AP, Reidenberg MM. Reidenberg
Grand Mal Seizure in a Child 30 Minutes
After Cyclogyl (Cyclopentolate and 10% NeoSynephrine (Phenylephrine Hydrochloride)
Eye Drops Were Instilled. Pediatrics. 2004
May;113(5):499-500.
9. Lee JM, Kodsi SR, Gaffar MA, et al.
Cardiopulmonary arrest following administration of Cyclomydril eyedrops for outpatient
retinopathy of prematurity screening. J AAPOS,
2014 Apr;18(2):183-4.
10. Brodsky MC, Baker RS, Hamed LM. Pediatric Neuro-Ophthalmology. New York: Springer
Press, 1996.
iTech
Spring 2015
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General, non-product-specific insurance deductibles above the co-pay amount are also not covered.
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EYLEA and EYLEA4U are registered trademarks of Regeneron Pharmaceuticals, Inc.
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© 2014 Novartis 02/14 CCS14004ADi

take-home - Modern medicine

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