Download Research and Clinical Practice - Review of Cornea and Contact

RCCL
JUNE 2016
REVIEW OF CORNEA
& CONTACT LENSES
SPECIAL ISSUE:
Research and
Clinical Practice
New Ideas from
ARVO 2016 P. 10
Post-Refractive
Rigid Lens Use P. 16
Fitting
Orthokeratology
Lenses P. 22
CXL and
Semi-Sclerals
P. 28
Reinventing
Brimonidine P. 40
Supplement to
Recycling Cyclosporine • Improving Patient Relations • Understanding Insurance Coverage
001_RCCL0616_Cover.indd 1
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contents
Review of Cornea & Contact Lenses | June 2016
departments
4
News Review
Considering New Treatments for
Neovascularization; Study on SPK
Lesion Size May Lead to Better
Equipment
6
My Perspective
Corneal Crosslinking:
Its Time Has Come
By Joseph P. Shovlin, OD
8
Pharma Science & Practice
Recycling Cyclosporine
By Elyse L. Chaglasian, OD,
and Tammy Than, MS, OD
40
Practice Progress
Brimonidine Breakup
By Mile Brujic, OD, and
Jason R. Miller, OD, MBA
42
Out of the Box
Making the Best of It
By Gary Gerber, OD
ON THE COVER
Optometry student photoshoot image
courtesy of Cardiff University in Cardiff,
Wales, United Kingdom.
Become a Fan on
Facebook
/ReviewofCorneaAndContactLenses
features
10
16
22
28
34
36
Building a Foundation for a
Better Future: ARVO 2016
Abstract Review
An expert weighs in on new ideas in the
field of cornea and contact lens care.
By Joseph P. Shovlin, OD
Fitting Rigid Lenses After
Refractive Surgery
Corneal and scleral GP lenses cover
the ‘last mile’ for patients who need
correction after LASIK and PRK.
By Melanie Frogozo, OD
Unusual Clinical Cases
in Orthokeratology
For the right patient, these lenses may
be life-changing. Two challenging cases
provide insights into the fitting process.
By Daddi Fadel, DOptom
Contact Lens Use Following
Corneal Crosslinking
An irregular cornea patient presents
needing better vision following a corneal
stabilization procedure. What do you do?
By Boris Severinsky, OD
Case Report:
Look Before You Judge
The most unique cases sometimes
present as the most mundane.
By Mohammad Tallouzi, OD
Medically Necessary
Contact Lenses: Medical
Plan or Vision Plan
Responsibility?
Do you know how to work with the
insurance company to achieve the
biggest bang for your buck?
By Robert L. Davis, OD
Follow Us On
Twitter
@RCCLmag
REVIEW OF CORNEA & CONTACT LENSES | JUNE 2016
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News Review
IN BRIEF
■ Certain characteristics including increased vascularity may be a risk factor
for recurrence of pterygium following
surgery, reports research published online
in the journal Cornea.1 Researchers in Korea
collected data on clinical and demographic
variables of 149 subjects including length,
width, area and vascularity of pterygium
and age and sex of patients. Anterior segment photos were taken prior to the procedure, and patients were followed up with at
one year postoperatively. Recurrence rate
was measured at 18.8% of the patients, with
univariate analysis demonstrating that relative length and width of the pterygium and
degree of vascularity were all correlated
with the trend. Multivariate analysis, however, demonstrated only higher vascularity
was correlated with recurrence. As such,
automated image analysis of anterior segment photos could assist with determining
which patients might develop pterygium
again, the researchers concluded.
1. Han SB, Jeon HS, Kim M, et al. Risk factors for
recurrence after pterygium surgery: an image analysis study. Cornea. 2016. [Epub ahead of print.]
■ Soft contact lens wearers with dry eye
symptoms may also exhibit reduced tear
menisci, reports a study in the May 2016
issue of Eye and Contact Lens.1 A reduction
in tear volume is one of the common factors
associated with ocular surface disease; indeed, previous research has indicated there
are more abnormal corneal nerve morphologic changes in patients with the aqueous
tear deficiency form of dry eye. However,
to date no research has examined whether
symptomatic contact lens wearers have
had a similar reduction in corneal nerve
density due to reduced tear volume. In this
study, scientists in China found that upper
and lower tear menisci height and area
were significantly lower in patients who
wore soft contact lenses, compared with
those who did not. Interestingly, this effect
occurred specifically in the midperipheral
area of the cornea.
1. Hu L, Chen J, Zhang L, et al. Effects of longterm soft contact lenses on tear menisci and
corneal nerve density. Eye Contact Lens. 2016
May;42(3):196-201.
■ A study investigating corneal densitometry and higher-order aberrations (HOAs)
one year post-transplantation of Bowman’s
layer found that corneal HOAs decreased
for both anterior and posterior corneal
surfaces following surgery, while corneal
backscattering increased. Neither trend
correlated with alterations in corrected
distance visual acuity, however. These results, published online in the journal Cornea,
suggest further research involving larger
populations with patient-subjective visual
outcomes and contrast sensitivity analysis is
needed to help further explain the effect of
corneal backscattering on optical quality.1
1. Luceri S, Parker J, Dapena I, et al. Corneal
densitometry and higher order aberrations after
bowman layer transplantation: 1-year results. Cornea. 2016. [Epub ahead of print.]
4
Considering New Treatments
for Neovascularization
A
flibercept may be a
better alternative than
bevacizumab in regulating the advancement of
corneal neovascularization, reports
research published online in the
journal Cornea.1 Previous studies
have investigated whether targeting vascular endothelial growth
factor—a key cytokine in the development of blood vessels in both
normal and abnormal patients (i.e.,
in the case of a tumor or in tissues
undergoing abnormal angiogenesis)—is a good way to possibly treat
this condition.
Researchers from Tel Aviv
University in Israel investigated the
effects of aflibercept or bevacizumab administered to Sprague-Dawley
rats with induced chemical burns.
Thirty-one animals were randomized to receive either subconjunctival injections of 0.08mL aflibercept
(25mg/mL), 0.05mL bevacizumab
(25mg/mL) or 0.05mL physiologic
saline using a 30-G needle applied
1mm distal to the limbus at the 6
o’clock and 12 o’clock positions.
Aflibercept is a VEGF-trap molecule that is both known to act as
a receptor decoy for all isoforms
of VEGF-A and also bind VEGF-B
and placental growth factors 1
and 2 to enhance the antiangiogenic response, while bevacizumab
has previously been confirmed to
inhibit chemically-induced neovascularization via its own action on
VEGF-A.2,3
Degree of corneal neovascularization was evaluated on post-injury days one, three, seven, nine
and 13 via corneal photography,
with burn area measuring 2mm in
diameter and comprising approximately 15% of the total corneal
area. Corneal samples were collected on day 21 for histological and
flat-mount immunofluorescence
analyses. Results in all three groups
indicated that neovascular sprouting began at the limbal area on day
three following injury and reached
maximum intensity around days
seven through nine; however, those
subjects treated with aflibercept
exhibited a significantly smaller
relative area of neovascularization than either the control or the
bevacizumab groups. Additionally,
a difference in the rate of change of
the neovascularized area over time
between the aflibercept group and
both the control and bevacizumab
groups was observed, but not between the control and bevacizumab
groups, suggesting the latter is not
as effective in this application.
“In conclusion, this suggests that
aflibercept may hold promise as an
effective modality for use in patients
with corneal neovascularization,”
the researchers conclude. As such,
“further investigation is warranted
to determine the efficacy of subconjunctival aflibercept in inducing
regression of preformed versus
mature corneal vessels, its minimum
effective dose and safety profile and
other possible modes of application
in animals and humans.”
RCCL
1. Gal-Or O, Livny E, Sella R, et al. Efficacy of
subconjunctival aflibercept versus bevacizumab for
preventional of corneal neovascularization in a rat
model.
2. Sener E, Yuksel N, Yildiz DK, et al. The impact of
subconjunctivally injected EGF and VEGF inhibitors
on experimental corneal neovascularization in rat
model. Curr Eye Res. 2011;36:1005-1013.
3. Oner V, Kucukerdonmez C, Akova YA, et al.
Topical and subconjunctival bevacizumab for corneal neovascularization in an experimental rat model.
Ophthalmic Res. 2012;48:118-123.
REVIEW OF CORNEA & CONTACT LENSES | JUNE 2016
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EDITORIAL REVIEW BOARD
Mark B. Abelson, MD
James V. Aquavella, MD
Edward S. Bennett, OD
Aaron Bronner, OD
Brian Chou, OD
Kenneth Daniels, OD
S. Barry Eiden, OD
Desmond Fonn, Dip Optom M Optom
Gary Gerber, OD
Robert M. Grohe, OD
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Patricia Keech, OD
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Mary Jo Stiegemeier, OD
Loretta B. Szczotka, OD
Michael A. Ward, FCLSA
Barry M. Weiner, OD
Barry Weissman, OD
Study on SPK Lesion Size May
Lead to Better Equipment
D
ata from a study on
epithelial lesion size in superficial punctate keratitis
(SPK) could help with the
development of automated algorithms to obtain more objective and
reliable classifications for corneal
staining, report researchers from
France in the journal Cornea.1
The isolated lesions that so often
characterize SPK are small fluorescent dots of differing size and incandescent intensity that are scattered
across the corneal surface. In some
cases, they can become confluent,
creating fluorescent areas in which
the individual lesions are no longer
distinguishable. Because the number
and specific locations of these dots
is an important clinical criterion
directly connected to the level of
surface integrity, differentiating
between them is critical—especially
during clinical trials. The new algorithms could help ease this issue.
In this study, the team from Jean
Monnet University, the University
Hospital of Saint-Etienne and the
Surgical Trends
A national study from Switzerland
suggests the number of
keratoconus-related corneal
transplants has decreased in
the last 10 years, while lamellar
techniques are being increasingly
performed. Furthermore, among
anterior lamellar keratoplasty
techniques, maximal depth DALK
is the most prevalent keratoplasty.
Frequency of penetrating
keratoplasty (PKP) is expected to
remain stable.1
1. Godefrooij DA, Gans R, Imhof SM, Wisse RPL.
Trends in penetrating and anterior lamellar
corneal grafting techniques for keratoconus: a
national registry study. Acta Ophthalmologica.
2016 Apr 7. [Epub ahead of print.]
Institut Universitaire de France
instilled fluorescein into 10 patients with dry eye graded using the
Oxford Scheme. Pictures were taken using a standard slit lamp with
cobalt blue light and no barrier
filter to simulate the most common
conditions of image acquisition.
Two magnification settings (i.e.,
x10 and x16) were used to focus on
the corneal objects in question that
measured 14.40µm and 7.81µm
under each setting, respectively. SPK
size did not differ between the five
Oxford Scheme grades of dry eye,
but did appear to be slightly smaller
than typical superficial epithelial
cells, which measure approximately
25x50µm.
“Our data on the size of SPK
staining lesions in this study is not
directly relevant to clinicians,”
the researchers acknowledged.
“However, it will prove useful for
researchers developing new devices and image analysis algorithms
to improve SPK severity grading. Indeed, if the size of isolated
epithelial lesions characterizing
SPK is known, it will be possible
to optimize device resolution to
detect individual lesions using the
appropriate filters or thresholds
and ultimately to precisely quantify
corneal staining.”
RCCL
1. Courrier E, Lepine T, Hor G, et al. Size of the
lesions of superficial punctate keratitis in dry eye
syndrome observed with a slit lamp. Cornea. 2016.
[Epub ahead of print.]
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My Perspective
By Joseph P. Shovlin, OD
Corneal Crosslinking: Its Time Has Come
Though the main treatment for ectasia remains contact lens use, a new procedure could
ease the fitting ordeal.
T
he Food and Drug
Administration’s recent
approval of the corneal
collagen crosslinking
procedure in the United
States means that we have gained
another valuable tool for treating
eye disease. Photrexa Viscous
(riboflavin 5’-phosphate in 20%
dextran ophthalmic solution)
0.146%, Photrexa (riboflavin
5’-phosphate ophthalmic solution)
0.146%, and the KXL system
(Avedro) will be promoted as the
only current FDA-approved therapeutic treatment for progressive
ectatic disorders like keratoconus.
The approval process for this
technology included three separate
studies over a period of several
years that were ultimately combined for meta-analysis to provide
reasonable assurance of both safety and efficacy. The NDA submission studies were randomized (i.e.,
treatment eye vs. sham treatment),
parallel group, open label placebo-controlled 12-month trials
conducted in the United States.
Resulting data found that the collagen crosslinked eyes demonstrated increased improvement in their
steepest keratometric readings
from month three to month 12.1
Yet while the system has been
approved for use, many eye
care practitioners may still have
questions regarding the procedure itself—namely, what does it
involve and what are the goals to
focus on when recommending corneal crosslinking to a patient? In
general, the procedure is simple to
perform. It involves use of a photosensitizer/enhancer (i.e., ribofla-
6
vin) that helps “cure” the cornea
with application of UVA light at
365nm to 370nm for approximately 30 minutes provided at
well-defined intervals and strength
levels. The goal of the procedure
is to halt further progression of
corneal disease and reduce corneal
surface and posterior irregularity
in patients with corneal ectasia.2
Total office visit time for both eyes
is roughly 90 minutes.
IN THE CHAIR
The procedure works on the
principle that when collagen fibrils
are crosslinked, they form strong
chemical bonds with one another.2
As we age, the cornea naturally
forms stronger bonds due to an
oxidative process that occurs
during end-stage changes to the
collagen. This may help explain
the fast progression of corneal
weakening that happens earlier
in life in patients who develop
keratoconus.2,3 The Europeans
were the first to employ corneal
crosslinking at the University of
Dresden in 1998 when animal
model corneas exposed to riboflavin and treated with UV light were
found to be “stiffer” and resistant
to enzymatic change over time.2
Potential candidates for the
procedure include anyone with
progressive ectasia, though most
often the procedure is performed
on those with keratoconus. Note,
however, there are a few contraindications like advanced ocular
surface or autoimmune disease,
significant corneal scarring or
opacity, infection or prior herpetic
disease. These are listed as such
because irradiation is part of the
procedure.
Interestingly, adjunct studies
to evaluate corneal crosslinking’s
efficacy in treating corneal infections are still being conducted;
however, results to date remain
mixed. Additionally, though this
is less of a concern in cases when
the epithelium remains in place
during the procedure, corneal
thickness cannot be exceedingly
thin or there is risk of toxicity to
the endothelium.
I
nvestigators continue to look
for alternatives for crosslinking
beyond use of riboflavin and UVA,
such as use of rose Bengal as a
marker and green light for treatment. In the meantime, however,
Avedro should be congratulated
for sponsoring several well-designed clinical trials that went
beyond simply including the
observational evidence that was
originally submitted for review.
Considering the limited number of potential patients and the
uncertainty regarding whether
insurance carriers will provide
coverage, Avedro remained committed throughout the approval
process. They may eventually be
able to expand indications for this
procedure to include treatment
of infectious keratitis, pain relief
in bullous keratopathy and other
novel indications.
RCCL
1. Avedro. Avedro Receives FDA Approval for Photrexa Viscous, Photrexa and the KXL System for
Corneal Cross-Linking. Available at: avedro.com/
press-releases/avedro-receives-fda-approval/.
Accessed May 10, 2016.
2. EyeWiki. Corneal Collagen Cross-Linking.
Available at: eyewiki.aao.org/Corneal_Collagen_
Cross-Linking. Accessed May 10, 2016.
REVIEW OF CORNEA & CONTACT LENSES | JUNE 2016
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Save the Date!
AC A D E M Y 2 0 1 6
ACADEMY 2016
Anaheim
NOVEMBER 9 - 12, 2016
Anaheim Convention Center
The Academy meeting is traveling to Southern California to offer attendees plenty of
sun, fun and exceptional cutting-edge CE! Join us in Anaheim for four days of superb
speakers, clinically-relevant sessions, an exceptional exhibit hall, fascinating papers
and posters and unforgettable social events.
Registration and housing now open!
http://www.aaopt.org/regsite
RCCL0616_House AAO.indd 1
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Pharma Science & Practice
By Elyse L. Chaglasian, OD, and Tammy Than, MS, OD
Recycling Cyclosporine
New formulations of an old drug may mean better treatments for dry eye.
T
hese days, it seems that
there is such a heavy emphasis on drug delivery
systems that many of
our current ophthalmic
pharmaceuticals are simply being
reformulated as “novel” therapies, rather than replaced entirely.1
Because the shortcomings of topical
drops are well-known, these delivery systems are aimed at eliminating
variability in drug concentration
with each dose to decrease dose
frequency and increase absorption.2
FIRST OUT
One such drug is CyclASol
(Novaliq), which incorporates
EyeSol, an ophthalmic drug delivery
technology based on semi-fluorinated alkanes (SFAs).3 SFAs have
been used for over a decade in the
management of retinal detachments
and overall have been well-tolerated
by patients. They are physically,
chemically and physiologically inert
and stable as well as water insoluble.4-7 Research shows the EyeSol
preparation does not require preservatives, so a multidose bottle can
be prepared without concern for
contamination. Droplet size of SFAs
is only 15µl compared with the
40µl or 50µl size of aqueous drops.
SFAs also exhibit low viscosity and
low surface tension, making them
less likely to cause blurry vision and
allowing for better wettability.3
Viscous vehicles like polyethylene
glycol and hyaluronic acid currently
used for ophthalmic solutions can
effectively solubilize hydrophilic
drugs. However, drugs that are
lipophilic (i.e., hydrophobic) like
cyclosporin A are more challenging;
as such, SFAs are effective solvents
8
for these medications.5,6 CyclASol
contains cyclosporin A in combination with perfluorobutylpentane, a
unique formulation with an SFA.
Earlier this year, 207 patients
were enrolled in a Phase II clinical
trial of CyclASol’s safety, tolerability and efficacy in treating moderate
to severe dry eye disease. Patients
were randomized into one of four
treatment groups, including two
CyclAsol groups (each containing a
different concentration of cyclosporin A), a vehicle control group and
an open-label cyclosporin A 0.05%
ophthalmic emulsion (Restasis)
group. Patients were directed to use
the study medication twice a day
for four months; researchers will
then evaluate the primary outcome
measure of corneal fluorescein
staining. Results are expected by the
end of 2016.8
Other research has already
demonstrated the drug’s absorption profile. In a pharmacokinetic
study involving rabbits, CyclASol
penetrated the lacrimal gland significantly better (14-fold increase)
than an oil-in-water emulsion.5
Additionally, results from a Phase
I trial of healthy volunteers who
received CyclASol eye drops or a
placebo and then switched to the
alternate option in the second phase
of the study found the drug offered
excellent tolerability and safety.2
SECOND ONE
IN THE RUNNING
Another drug under consideration
is Seciera (Auven Therapeutics),
a nanomicellar formulation of
cyclosporine previously known as
OTX-101. Nanomicelles are tiny
particles comprised of a hydropho-
bic core surrounded by a hydrophilic shell that measure 10nm
to 100nm large. They are used to
solubilize hydrophobic drugs and
are believed to increase ocular
bioavailability, minimize degradation and improve penetration of the
drug—all of which make them an
excellent drug delivery method. Use
of nanomicelles allows for cyclosporine to be formulated in a clear,
preservative-free, isotonic aqueous
solution.9,10
In a Phase IIB/III clinical trial,
455 patients in a randomized,
double-masked study at 28 sites
received either 0.05% cyclosporine,
0.09% cyclosporine or the vehicle
as the control. All drops were administered twice a day for 84 days.
Co-primary outcome measures
consisted of changes in both conjunctival staining and global symptom scores from baseline. Results
indicated both concentrations of
Seciera were statistically superior
to the placebo on both co-primary
endpoints. Additionally, the 0.09%
concentration also demonstrated
an improvement in tear production
and corneal staining.
Ultimately, however, the 0.09%
concentration was superior to the
0.05% and so will be used in an
additional Phase III trial to reconfirm some of the earlier findings.8,11
This study will enroll 700 patients
at 50 sites who will be randomized to receive either cyclosporine
0.09% or the vehicle (control) for
12 weeks. Researchers will look
for the number of subjects with
a clinically significant increase
in Schirmer’s score as compared
with baseline. Secondary measures
include lissamine green conjunctival
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staining, fluorescein corneal staining
and changes in symptom score.
Enrollment for this study began in
February 2016. It is expected to
conclude by the end of the year.8
Reports suggest a long-term safety
study is also planned for 2016 that,
if successful, may yield a new drug
application for Seciera in 2017.11
A for the treatment of severe active
vernal keratoconjunctivitis (VKC)
in Europe. The drug—tentatively
named Vekacia—met its primary
and key secondary endpoints in
a multicenter, randomized, placebo-controlled study of patients
ranging in age from four to 18 years
old.
KICKING KERATITIS
TO THE CURB
Ikervis (Santen Pharmaceutical)
was approved last year as the first
ophthalmic drug to treat severe
keratitis in adults with dry eye in
Europe. Ikervis contains 1mg/mL
of cyclosporin A and is formulated
as a cationic oil-in-water emulsion.
Drug retention time was improved
using a cationic nanoemulsion platform technology (i.e., Novasorb).
The drug is formulated as a series of
nano-sized droplets, which increase
the surface area-to-volume ratio
and improve ocular surface exposure to the drug, allowing Ikervis to
be given to the patient just once a
day.12,13
Also, Santen recently completed a
Phase III study, Vektis, evaluating a
1mg/mL formulation of cyclosporin
CYCLOSPORINE REBORN
Allergan announced last fall it had
submitted a supplemental document
to the FDA for approval of a multidose preservative-free bottle of
cyclosporin A 0.05%.14 The bottle
will contain the equivalent amount
of 60 single-unit vials and is a firstof-its-kind product with a unidirectional valve and air filter technology
designed to prevent the need for
a preservative to be included. The
FDA did request more chemistry,
manufacturing and control (CMC)
information regarding the bottle.
M
onitoring clinical trial outcomes of these drugs will
surely be an interesting process.
Restasis may soon have to share
the limelight with more cyclosporine-based cousins.
RCCL
What’s In a Name?
Cyclosporine was initially developed to suppress the immune
response and prevent organ rejection in transplant patients. It was
later brought to market in 1983 for oral and parenteral administrations; however, the drug exhibited poor solubility and had widely
variable bioavailability, so it was then formulated as a microemulsion in 1995 to address some of the malabsorption concerns. The
drug is referred to by at least three nonproprietary names: cyclosporine by the United States Adopted Names Council, cyclosporin
by the British Pharmacopoeia and ciclosporin as the drug’s international non-proproprietary name designed by the World Health
Organization.15 It is also commonly referred to as cyclosporin A, as
an alternative to cyclosporine, in some applications.
1. Novack GD. Eyes on new product development.
J Ocul Pharmacol Ther. 2016 Mar;32(2):65-6.
2. Drug Development & Delivery. EyeSol: a novel
topical ocular drug delivery system for poorly
soluble drugs. Available at: www.specialtypharma.com/Main/Back-Issues/EyeSol-a-Novel-Topical-Ocular-Drug-Delivery-System-137.aspx.
Accessed Mar 1, 2016.
3. ONdrugDelivery. An integrated pipeline of
ophthalmic products based on eyeSol delivery
technology. Available at: www.ondrugdelivery.
com/publications/54/Novaliq.pdf. Accessed Mar
1, 2016.
4. Meinert H, Roy T. Seminfluorinated alkanes – a
new class of compounds with outstanding properties for use in ophthalmology. Eur J Ophthalmol. 2000 Jul-Sep,10(3):189-97.
5. Steven P, Scherer D, Krosser S, et al. Semifluorinated alkane eye drops for treatment of dry eye
disease – a prospective, multicenter noninterventional study J Ocul Pharmacol Ther. 2015
Oct;31(8):498-503.
6. Dutescu R, Panfil C, Merkel O, Schrage N.
Semifluorinated alkanes as a liquid drug carrier
system for topical ocular drug delivery. Eur J
Pharm Biopharm. 2014 Sep;88(1):123-8.
7. Broniatowski M, Dynarowicz-Latka P. Semifluorinated alkanes – primitive surfactants of
fascinating properties. Adv Colloid Interface Sci.
2008 May 19;138(2):62-83.
8. Novaliq. Novaliq announces last patient enrolled in phase 2 clinical trial of cyclasol for the
treatment of moderate to severe dry eye disease.
Available at: www.novaliq.de/en/news/press-releases/. Accessed May 15, 2016.
9. Vadlapudi AD, Mitra AK. Nanomicelles: an
emerging platform for drug delivery to the eye.
Ther Deliv. 2013 Jan;4(1):1-3
10. Guo C, Zhang Y, Yang Z, et al. Nanomicelle
formulation for topical delivery of cyclosporine
A into the cornea: in vitro mechanism and in vivo
permeation evaluation. Nature. 2015;Aug:1-14.
11. Auven Therapeutics. Auven Therapeutics announces positive results from pivotal clinical trial
of seciera (OTX-101) in dry eye disease. Available
at: www.auventherapeutics.com/pr/Seciera%20
P3%20Results%20Release.pdf. Accessed: Mar
1, 2016.
12. Santen. Santen announces approval of Ikervis
for EU marketing authorization. Available at:
www.santen.com/en/news/20150325.pdf. Accessed: May 15,2016.
13. The Ophthalmologist. Introducing Ikervis.
Available at: theophthalmologist.com/issues/0615/introducing-ikervis/. Accessed: May
15, 2016.
14. EyeWireToday. In complete response letter,
FDA requests more information from Allergan for multi-dose preservative-free restasis.
Available at: eyewiretoday.com/2016/03/11/
allergan-receives-complete-response-letterfrom-fda-for-prior-approval-supplement-forrestasis-cyclosporine-ophthalmic-emulsion-005multi-dose-preserv. Accessed: May 15, 2016.
15. David Moore’s World of Fungi. Origin of drugs
in current use: the cyclosporine story. Available
at: www.davidmoore.org.uk/Sec04_01.htm.
Accessed May 26, 2016.
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BUILDING A FOUNDATION
FOR A BETTER FUTURE:
ARVO 2016
ABSTRACT REVIEW
An expert weighs in on new ideas in the field of cornea and contact lens care.
By Joseph P. Shovlin, OD
W
idespread
change is
happening
at a breakneck pace in
the ophthalmic field, though new
research and concepts for future
studies remain cornerstones for
all advancements. This year’s
Association for Research in Vision
and Ophthalmology’s (ARVO)
meeting in Seattle, Wa. offered
practitioners a peek at some of the
newest discoveries and advances
designed to aid in clinical practice.
Areas of study included dry eye and
associated comfort issues, keratoconus and its treatments and bacterial
infections related to contact lens
wear.
INFECTION AND
INFLAMMATION
Data collected on antibiotic resistant-bacteria highlights changing
trends, report researchers who
evaluated the frequency of methicillin-resistant Staphylococcus
(MRS) keratitis as it appeared in
a referral ophthalmology center
in Mexico City, Mexico from
February 2014 to February 2015.1
The bacteria identified via diagnosis
of infectious keratitis and positive
culture predominantly included
Staphylococcus, with those organisms that were drug resistant noted
as being non-responsive to oxacillin
and/or cefoxitin disk diffusion.
These results are concerning because resistance to multiple antibiotics means treatment options are
limited.
Antibiotic resistance trends
should be kept in mind when
selecting therapy preoperatively, researchers from New York
suggest.2 Use of topical antibiotics
is key to help with minimizing
intraocular infections prior to and
following surgery, as bacterial resistance continues to be a prevalent
issue and can inhibit an otherwise
positive therapeutic effect. In this
study, the investigators examined
the resistance profiles of common
bacterial pathogens to the antibiotics that are routinely used by
ophthalmologists. One hundred
and seventy-two aqueous and
vitreous humor isolates of note
were collected from the ARMOR
surveillance study, including 11
with Haemophilus influenzae, 10
with Pseudomonas aeruginosa, 21
with Streptococcus pneumoniae,
30 with Staphylococcus aureus,
and 100 with coagulase-negative
staphylococci (CoNS). Minimum
inhibitory concentrations (MICs)
were determined by broth microdilution and the isolates were categorized as susceptible, intermediate
or resistant according to systemic
breakpoints. Results from the study
indicated antibiotic resistance was
most prevalent among staphylococci, particularly CoNS, with
higher rates of opposition observed
to azithromycin, ciprofloxacin
and oxacillin/methicillin. At least
70% of the methicillin-resistant
staphylococci samples collected
demonstrated multidrug resistance;
furthermore, among S. pneumoniae
isolates, resistance was highest to
azithromycin, chloramphenicol and
oral penicillin.
Another study evaluated povidone iodine (PI) as a potential
disinfecting solution for contact
lenses, focusing on its antimicrobial
efficacy against ocular bacterial
strains in planktonic form and
following biofilm formation in the
contact lens case.3 Researchers in
New South Wales, Australia found
that the PI solution performed exceptionally well against the planktonic forms of all bacteria strains
tested; in fact, no viable organisms
were recovered following the
minimum recommended disinfection time. The PI solution was
also effective to varying degrees
at removing the bacterial biofilm;
air-drying or wiping the lens case
ABOUT THE AUTHOR
Dr. Shovlin is the senior optometrist at Northeastern Eye
Institute and a member of the
adjunct faculty at the Pennsylvania College of Optometry. He is also the clinical
editor for Review of Cornea
& Contact Lenses, associate
clinical editor for Review of
Optometry and president-elect for
the American Academy of Optometry.
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Photo: Christine W. Sindt, OD
From left to right: Moraxella nonliquefaciens ulcer, Pseudomonas ulcer and HZO neurotrophic cornea with bacterial
superinfection. Research from this year’s ARVO conference could lend insight into treating these issues.
with a tissue and then air-drying
was deemed most effective (71%
of the biofilm was removed), while
recapping the lens case wet was less
so (55% removed). As such, results
demonstrate not only that ocular
strains of bacteria are susceptible to
povidone iodine in planktonic and
biofilm form, but also reiterates the
importance of air-drying in maintaining lens case hygiene.
Directed energy at certain wavelengths may be capable of eliminating the presence of Acanthamoeba
from contact lenses and lens cases,
report researchers in Pennsylvania,
who hypothesized that certain
levels of ultraviolet energy administered with and without riboflavin will eradicate Acanthamoeba
while maintaining the clarity of the
contact lens.4 To test this theory,
the team administered multiple
modes of energy in microjoules/
cm² x 100 in a dose-dependent
manner. Three groups were prepared: Acanthamoeba castellanii
(106 cysts in saline) exposed to
just UVE; Acanthamoeba castellanii (106 cysts in saline) plus soft
contact lens exposed to just UVE;
and Acanthamoeba castellanii (106
cysts) plus soft contact lens exposed
to UVE in a saline solution or
0.01% riboflavin. The soft contact
lenses were evaluated for clarity
following exposure via spectrophotometry. Results indicated a total
UVE amount of 89,991 micro-
joules/cm² x 100 for a time length
of 180 minutes is required to eliminate the presence of Acanthamoeba
castellanii in all three groups.
Though the rate of complications
associated with scleral lens wear
remains low, certain issues continue to be prevalent and should
be further monitored, according
to researchers from Minnesota,
Illinois, Ohio and Massachusetts,
who collected data from a 19-question survey regarding scleral lens
wear and management practices
administered to eye care practitioners between January 12, 2015
and March 31, 2015 by the Mayo
Clinic Survey Research Center.5
Nine hundred and eighty nine
individuals responded to the survey,
723 of whom reported fitting five
or more patients with scleral lenses
for a total of 84,735 scleral lens patients represented. Reported issues
included edema, neovascularization, infiltrates, toxic keratopathy,
bullae and microbial keratitis as
well as limbal stem cell compromise, elevated intraocular pressure,
uveitis and retinal detachment.
Handling error was reported as the
primary cause of these problems in
448 patients.
DRY EYE
Keratoconjunctivitis sicca (KCS)
pathology may be improved via
topical antioxidant therapy, report
researchers from the United States,
Finland and Lithuania.6 In this
study, six-week-old mice were
exposed to a desiccating environmental chamber with airflow
and humidity levels set at 15 L/
min and 5%, respectively, for
10 days. Each mouse received
transdermal scopolamine in their
left eyes twice daily with superoxide dismutase (SOD) mimetic
Manganese (III)-5,10,15,20-tetrakis
(N-methylpyridinium-2-yl) porphyrin Pentachloride (MnTM-2-PyP,
EMD Millipore) diluted in physiological saline at 0.05%. Their right
eyes served as controls and were
treated with saline. Study results
indicated the topical administration
of the MnTM-2-PyP significantly
improved lacrimal gland pathology
compared with the effects of the
saline control, suggesting topical
antioxidant therapy may be feasible
as a treatment for KCS.
A study from investigators at
Cornell Medical College, University
of Illinois College of Medicine and
Indiana University of Medicine
suggested exposure of the corneal surface to hyperosmotic tears
may cause considerable damage to
corneal subbasal nerve fibers.7 The
researchers studied the relationship
between tear hyperosmolarity and
corneal nerve abnormalities for
the recorded first time ever in an
effort to explain the common signs
and symptoms associated with dry
eye disease. Results indicated the
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ARVO 2016 ABSTRACT REVIEW
Photo: Christine W. Sindt, OD
Anterior segment OCT measurements could help practitioners assess ocular
surface dryness in patients with conjunctovochalasis.
responses of the corneal neurons
to the drying of the cornea were
depressed or completely abolished
by hyperosmolar tears in a timely and dose-dependent manner.
The researchers observed that the
disappearance of action potentials
occurred as quickly as two minutes, but generally within three
hours following application of the
tear solutions and suggested these
findings are consistent with the
abnormal activities of trigeminal
ganglion neurons demonstrated
by electrophysiological recordings
and may account for the signs (i.e.,
morphological abnormalities) and
symptoms (i.e., abnormal sensations) reported in dry eye patients.
Dry eye disease may also play a
role in inhibition of corneal graft
survival, says a team of scientists from Schepens Eye Research
Institute, Harvard Medical School
and the Juntendo University School
of Medicine in Japan.8 These
researchers evaluated the effect of
the condition on allosensitization
and graft rejection by transplanting
healthy corneas with dry eye dis-
ease from donor mice onto recipient mice. Graft survival rates and
opacity scores were evaluated with
slit lamp biomicroscopy. Corneas
and draining lymph nodes were
harvested at day 14 post-transplant
and findings demonstrated that the
transplant recipients with the DED
donor corneas demonstrated significantly reduced graft survival (i.e.,
10%) as compared with control
mice (50% survival).
Other research from Germany on
omega-3 fatty acids (O3F) indicates
they could be used as potential
topical adjunct therapy for dry
eye.9 Oral and topical treatments
that use omega-3 fatty acids have
previously demonstrated positive
effects on the severity of dry eye. In
the current study, experimental dry
eye (EDE) was induced in mice and
topical therapy was administered.
Therapeutic treatment of mice
with omega-3-fatty acids using a
semi-fluorinated alkane (F6H8)
as a preservative-free lipophilic
carrier demonstrated a significantly
earlier decrease of epithelial damage following EDE as compared
with untreated controls or another
treatment. The amount of tear fluid
also increased following 03F/F6H8
treatment as compared with levels
of the same in untreated controls
or those treated with F6H8 alone
or with artificial tears, as did the
number of goblet cells.
Additionally, anterior segment
optical coherence tomography
(AS-OCT) may be appropriate for
clinicians to use in assessing the
level of ocular dryness in patients
with conjunctivochalasis, report
researchers from the University
of Jukui in Japan, who compared
tear meniscus area and height in
patients with the disease and those
with normal eyes.10 Potential relationships between TMA or TMH
and fluorescein film tear-breakup
time, fluorescein staining score and
the extent of conjunctivochalasis
were also evaluated in the conjunctivochalasis group. Results
indicated that conjunctivochalasis
eyes exhibited a reduced TMA
and increased TMH as compared
with the normal eyes. Note, a more
severe dry eye condition in conjunctivochalasis is commonly associated
with a reduction in TMA, despite
a high level of TMH due to the
conjunctival fold. As such, AS-OCT
technology may be appropriate for
use in this type of patient scenario.
Japanese researchers in the
field also suggest that addressing the presence of patient sleep
disorders may help alleviate cases
of dry eye.11 A cross-sectional
case control study involving 715
outpatients diagnosed with DED,
chronic conjunctivitis or allergic
conjunctivitis incorporated the
Pittsburgh Sleep Quality Index
(PSQI) and Hospital Anxiety and
Depression Scale (HADS) as a
means to evaluate their well-being.
Regression analysis of patients with
DED revealed correlations between
higher PSQI and HADS and the
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Photos: Jennifer Harthan, OD
Meibomography images demonstrating the effects of electronic device use
on ocular dryness.
ly results in a notable decrease in
quality of life. This study attempted
to quantify the symptoms most frequently associated with eye fatigue
while using digital devices in soft
contact lens wearers, who were
asked to complete a survey with
questions pertaining to the condition. Eighty-eight percent reported
experiencing eye fatigue once per
month, while 74% reported experiencing eye fatigue at least once per
week. Reported symptoms included
dryness, eye irritation, eyestrain
and tired eyes. Strain, soreness,
tiredness and headache comprised
primary sensation factors, while
burning, irritation and dryness
comprised the secondary sensation
factors in the study. Additionally,
blurring, doubling and moving/
floating were noted as visual sensation factors. The researchers concluded that frequent and severe eye
fatigue is highly prevalent among
the population of soft contact lens
wearers that use digital devices, and
that the recorded symptoms can be
used to better identify members of
this population.
According to German investigators in Cologne who examined the
onset of DED pain symptoms like
burning, stabbing or photophobia
that presented without accompanying clinical signs including
normal visual acuity, intraocular
pressure, Schirmer test and corneal
fluorescein staining in combination
with pathological Ocular Surface
Disease Index score, there is a
correlation between patients with
a discrepancy of signs and symptoms in dry eye that are resistant
to therapy and the presence of
psychosomatic diseases and/or
previous eye surgery.14 Typically, in
these cases of symptoms without
signs, corneal neuralgia is postulated; however, the results from this
study that indicate the co-morbidities of psychosomatic disease or
prior eye surgery suggest there may
be different sensitization pathways
for the proposed development of
corneal neuralgia than previously
believed. Furthermore, incomplete
analgesia following topical corneal
anesthesia supports the assumption
of a central sensitization that would
explain the resistance to topical
therapy, the researchers concluded.
A cross-sectional study open to
all participants of the American
Academy of Optometry’s 2015
annual meeting suggested that the
Photo: Christine W. Sindt, OD
presence of DED, rather than other
forms of ocular surface disease.
There was also a connection to the
condition’s level of severity, further
raising quality-of-life concerns and
supporting the theory that providing psychiatric help to address
a patient’s sleep issue may have a
direct effect on the improvement of
their ocular health.
Patients who use digital devices
throughout the day, regardless of
their age, may experience adverse
impacts on their work performance, productivity and quality of
vision, suggests a team of researchers from Illinois, Pennsylvania,
California and Tennessee.12 Overall,
eye care practitioners have noted
an increase in dry eye symptoms as
the use of digital devices—including handheld tablets, smartphones,
laptops and computers—increases.
Data collected from questionnaires
related to digital device use as well
as additional answers regarding
vision fluctuation concerns and
contact lens wear were used to
generate results for the study. Six
hundred and eighty-six subjects
were evaluated, with the average
number of hours spent on devices
per day noted at 6.35 hours for the
<40 age group and 4.83 hours for
the >40 age group. Average ocular
comfort was recorded on a scale of
one to 10 as one at the beginning
of the day and seven at the end of
the day following gratuitous digital
device use, further demonstrating a
positive correlation.
A second study organized by researchers in Indiana and California
in cooperation with CooperVision
found that frequent and severe
eye fatigue is prevalent among
soft contact lens wearers who use
digital devices.13 Previous reports
have found that eyestrain or eye
fatigue occurs in roughly 60% of
student and working populations
that use digital devices and typical-
Pseudophakia and severe dry eye
from graft-versus-host disease.
Researchers presenting at this year’s
ARVO conference found that dry eye
may inhibit survival of corneal grafts.
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ARVO 2016 ABSTRACT REVIEW
Standard Patient Evaluation of Eye
Dryness (SPEED) questionnaire
may not be as successful at detecting dry eye in contact lens wearers
as it is in those who do not wear
lenses.15 One-hundred and fifty
contact lens wearers and 134 nonlens wearers elected to participate
in the study by answering the questions listed as part of the SPEED
questionnaire and undergoing
tear meniscus height photographic
assessment and tear volume testing.
Unfortunately, while the questionnaire was accurately able to predict
the dry eye status in non-contact
lens wearers, it was unable to
predict the same in those wearing
lenses. The researchers concluded
additional work should be conducted to further assess the study’s
usefulness in contact lens wearers.
Furthermore, artificial tears may
be less beneficial than initially
believed for patients with ocular
surface disease, according to investigators from Virginia who incorporated a modified version of the
Schirmer test into their research.16
Study participants were divided
into three groups: a control group
not treated with artificial tears, a
group with ocular surface symptoms that responded to artificial
tear treatment, and a group with
similar ocular surface symptoms
that did not respond to the tears.
No significant difference in standard Schirmer test scores, modified
Schirmer test scores, punctate epithelial erosion presentation (PEE),
meibomian gland dysfunction
(MGD), blepharitis tear break-up
time (TBUT) or Ocular Surface
Disease Index (OSDI) scores was
noted in any group. The researchers
concluded that current clinical tests
are not able to adequately identify
the subset of patients who might
most benefit from artificial tear use.
Given the low cost and morbidity
of artificial tear treatment, they
suggest a trial treatment of the
prescribed drops be performed in
patients with chronic ocular surface
symptoms and add that future
studies should take into account the
type of artificial tears used as well
as frequency of use.
KERATOCONUS AND ITS
POTENTIAL REMEDIES
In Australia, investigators examined changes in corneal sensitivity
Photo: Christine W. Sindt, OD
A slit lamp view of a keratoconic patient with hydrops. Research is
increasingly looking at the implications of this irregular corneal condition
and potential methods for its management.
and their association with other
clinical parameters in keratoconus
patients.17 Ocular symptoms using
validated questionnaires, corneal
topography, tear osmolarity, tear
meniscus height measurement,
tear volume, ocular surface staining with fluorescein and lissamine
green dye, corneal sensitivity using
Cochet-Bonnet aesthesiometer
and corneal nerve mapping using
HRT II confocal microscopy were
recorded, and correlations were
made using either Spearman’s or
Pearson’s coefficient. Subjects were
graded as having either mild or
severe keratoconus, and partial correlation was performed to control
the effect of confounding factors.
Only data from each patient’s most
severe eye was included in the
study. Results found central corneal
sensitivity to be lower in the severe
keratoconus group, while in bivariate correlations, decreased corneal
sensitivity in keratoconus was
associated with condition severity,
lower central nerve fiber density,
contact lens wear, contact lens
tolerance, patient age and duration
of disease. Researchers further observed a distinctive trend in which
age and duration of keratoconus
was also associated with decreased
corneal sensitivity, and that contact
lens wear-intolerants exhibited
higher corneal sensitivity compared with tolerant wearers. They
concluded that decreased corneal
sensitivity was associated with age
and duration of disease, and that
reduced tolerance of keratoconic
patients to contact lens wear was
associated with increased corneal
sensitivity.
Hair cortisol concentration as a
biochemical correlate of chronic
psychological stress may be an
observable risk factor for keratoconus, report German scientists
who analyzed strands of hair taken
from both healthy and keratoconic
14 REVIEW OF CORNEA & CONTACT LENSES | JUNE 2016
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patients.18 As hair segments of 3cm
in length represent the prior threemonth stress profile of an individual, the researchers used sections
of hair this length located most
proximal to the scalp. Cortisol levels were determined using the hair
by the Institute of Biopsychology
of the TU Dresden; a standardized
questionnaire for chronic stress was
also administered to all subjects.
Results indicated hair cortisol was
higher in patients with progressive keratoconus compared with
those with a stabilized form of the
disease or those who were healthy.
Furthermore, the study suggested
increased hair cortisol concentration could be a risk factor for the
progression of keratoconus.
Other research from Germany
supports the concept that axis
alignment could be used in an
algorithm to support the diagnosis and staging of keratoconus.19
Scientists compared the power and
axis orientation of anterior and
posterior astigmatism in 861 eyes
with keratoconus and 500 healthy
eyes as part of a retrospective study,
finding posterior axis alignment
of corneal astigmatism is in line
with the alignment of the anterior
surface in the majority of cases
of keratoconus. In contrast, the
majority of the healthy eye group
demonstrated a vertical posterior
axis alignment independent of
the anterior surface. These results
indicate that with progression
of the disease and a decrease in
pachymetry, corneal resistance to
vertical forces—most likely the eyelids—decreases and axis orientation
becomes increasingly vertical.
Corneal crosslinking may
effectively relieve the intensity
and frequency of pain associated
with bullous keratopathy for at
least one year following treatment, report researchers in Tokyo,
Japan, who conducted a retrospec-
tive observational case study to
monitor post-operational results
of 11 patients who had undergone surgery for the condition.20
Patient best-corrected visual acuity
(BCVA), intraocular pressure and
corneal thickness were examined
prior to treatment, as well as at
one-week, and three-, six- and
12-month intervals following treatment. Intensity and frequency of
pain were scaled from zero to 10,
while after 12 months of treatment, corneal stromal depths of
100µm and 200µm were observed
using confocal microscopy. Density
of the patients’ keratocytes and
nerve fibers was also calculated.
Results indicated that BCVA did
not significantly improve following
treatment, but pain—which was
initially scored at an average of
6.27—decreased. Furthermore, the
mean pain frequency score of 5.45
also decreased following treatment
to 1.27 at 12 months post-operation, while keratocytes and nerve
fibers were rarely observed at 12
months following the procedure.
Persistence of pain relief was ultimately attributed to the inadequate
regeneration of nerve fibers in the
corneal stroma.
O
ther abstracts from ARVO
2016 highlight alternative
treatment options, surgical techniques and potential concerns on
the horizon to be aware of. As always, practitioners are encouraged
to review the full list of available
abstracts, not just those chosen for
this report. So, go take a look!
RCCL
1. Avila-Lule I, Teran-Tejada T, Betancourt NR, et
al. Methicillin-resistant staphylococcus keratitis in
a referral ophthalmology center. Program 2354.
Association for Research in Vision and Ophthalmology Meeting 2016.
2. Asbell PA, DeCory H, Sahm D, Sanfilippo CM. In
vitro antibiotic susceptibility of ocular pathogens
collected from the aqueous and vitreous humor
during the ARMOR surveillance study. Program
2348. Association for Research in Vision and Ophthalmology Meeting 2016.
3. Vijay AK, Liu L, Nguyen TC, et al. Efficacy a novel
povidone iodine based contact lens disinfection
system against bacterial biofilm. Program 1454.
Association for Research in Vision and Ophthalmology Meeting 2016.
4. Ross AGG, Kowalski RP, Dhaliwal D, KArenchak
LM. The threshold of light energy to eliminate acanthamoeba. Program 1456. Association for Research
in Vision and Ophthalmology Meeting 2016.
5. Schornack M, Harthan J, Barr et al. Complications of scleral lens wear. Program 1467. Association for Research in Vision and Ophthalmology
Meeting 2016.
6. Kaja S, Kourlen P, Puranen J, Symantas R. A
topically delivered synthetic metalloporphyrin SOD
mimetic improves hallmarks of dry eye disease
pathology. Program 396. Association for Research
in Vision and Ophthalmology Meeting 2016
7. Mizerska KK, Hirata H, Dallacasagrande V, et al.
Short exposure to hyperosmolar tears produces
profound anatomical and physiological changes
in rodent corneal nerves: implications for dry eye
disease. Program 403. Association for Research in
Vision and Ophthalmology Meeting 2016.
8. Inomata T, Hua J, Shiang T, et al. Is dry eye
disease in donors a risk factor for corneal graft
rejection? Program 1438. Association for Research
in Vision and Ophthalmology Meeting 2016.
9. Gehlsen U, Braun T, Steven P. Omega-3 fatty
acids using a F6H8-carrier as topical therapy in
experimental dry eye disease. Program 417. Association for Research in Vision and Ophthalmology
Meeting 2016.
10. Kimura K, Takamura Y, Gozawa M, et al. Difference in tear meniscus between conjunctivochalasis
eyes and normal eyes using anterior segment
optical coherence tomography. Program 2836.
Association for Research in Vision and Ophthalmology Meeting 2016.
11. Ayaki A, Kawashima M, Negishi K, et al. Sleep
disorders in dry eye disease and allied irritating
ocular diseases. Program 2840. Association for Research in Vision and Ophthalmology Meeting 2016.
12. Harthan J, O’Dell L, Kwan JT, et al. Dry eye
symptoms and visual function with digital device
use. Program 2843. Association for Research in
Vision and Ophthalmology Meeting 2016.
13. Kollbaum PS, Meyer D, Huenick S, et al. Digital
Device user survey of eye fatigue. Program 1492.
Association for Research in Vision and Ophthalmology Meeting 2016.
14. Steven P, Schneider T, Ramesh I, et al. Pain in
dry-eye patients without corresponding clinical
signs – a retrospective analysis. Program 2848.
Association for Research in Vision and Ophthalmology Meeting 2016.
15. Pucker AD, Jones-Jordan L, Kwan JT, et al. A
comparison of SPEED scores in contact lens and
non-contact lens wearers. Program 2855. Association for Research in Vision and Ophthalmology
Meeting 2016.
16. Young M, Zhong H, Peterson E, et al. Clinical
evaluation of Schirmer test variations on the predictability of benefit from artificial tears. Program
2882. Association for Research in Vision and
Ophthalmology Meeting 2016.
17. Mandathara PS, Stapleton F, Kokkinakis J,
Willcox MD. A pilot study of corneal sensitivity
and its associations in keratoconus. Program 2896.
Association for Research in Vision and Ophthalmology Meeting 2016.
18. Lenk J, Spoerl E, Pillunat LE, Raiskup F. Hair cortisol analysis in progressive and stable keratoconus
patients. Program 2906. Association for Research
in Vision and Ophthalmology Meeting 2016.
19. Schmack I, Shajari G, PourSadeghian M, et al.
Characteristics of corneal astigmatism of anterior
and posterior surface in healthy individuals and
keratoconus patients. Program 2913. Association
for Research in Vision and Ophthalmology Meeting
2016.
20. Ono T, Terada Y, Mori Y, et al. The persistence of
pain relief after corneal crosslinking in mild bullous
keratopathy eyes. Program 2919. Association for
Research in Vision and Ophthalmology Meeting
2016.
REVIEW OF CORNEA & CONTACT LENSES | JUNE 2016
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Fitting Rigid
Lenses
After Refractive Surgery
Corneal and scleral GP
lenses cover the ‘last
mile’ for patients who
need correction after
LASIK and PRK.
By Melanie Frogozo, OD
D
espite the advances
in PRK and LASIK in
the past two decades,
there are still patients
who have complications from these procedures that
keep them from experiencing the
vision they expected. In these
circumstances, contact lenses can
help restore vision. However, many
individuals who have elected to
undergo surgery are often unhappy
about the idea of wearing correction again. Therefore, it is important to be both skilled and efficient
at fitting contact lenses for this
population.
Gas permeable (GP) lenses are a
good choice for fitting patients after refractive surgery. These lenses
have excellent optics and can mask
several diopters of regular and irregular astigmatism. Additionally,
the practitioner has complete control over the lens parameters and
the lenses can be made in high Dk
materials. This article will review
GP lens fitting after refractive surgery using a series of case studies.
CORNEAL SHAPE
CONSIDERATIONS
Fitting patients who have undergone refractive surgery is challenging due to their altered corneal
shape. A typical cornea has a
prolate shape, i.e., steeper centrally
with flattening towards the periphery. The rate of flattening towards
the periphery can be described
by its eccentricity value. Normal
corneas typically have eccentricity
values of 0.5 to 0.7.
Hyperopic LASIK/PRK is accomplished by ablating the peripheral
cornea in order to steepen the
central cornea. These patients have
a corneal profile similar to keratoconus and an eccentricity value of
greater than 1.0. And so, keratoconic design lenses can be helpful
in fitting those who have had a
hyperopic procedure done.
Myopic surgery is accomplished
by ablating the central cornea in
order to make it flatter, which
causes the peripheral cornea to
steepen. This reverse corneal configuration is oblate in shape and
has a negative eccentricity value.
A reverse geometry design contact
lens can be used to align better
with the corneal profile of a patient
who has had myopic refractive
surgery.
The initial contact lens design
after refractive surgery can be determined by looking at the eccentricity value. Values greater than
ABOUT THE AUTHOR
Fig. 1. Right eye axial power corneal topography post-hyperopic LASIK.
Dr. Frogozo, a fellow of the
AAO, is the owner and
director of Alamo Eye
Care and the Contact Lens
Institute of San Antonio
in San Antonio, Texas. She
specializes in difficult-to-fit
contact lenses for both adult
and pediatric patients.
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1.0 could be fit into a keratoconic
lens. If the eccentricity value is
negative, consider fitting a reverse
geometry design.3
Corneal topography can also
help practitioners choose contact
lens parameters after refractive
surgery. The initial base curve of a
corneal GP lens can be determined
after refractive surgery by taking
an average dioptric curvature
4.0mm away from the center on
axial curvature maps and 2.0mm
on tangential curvature maps.4
Additionally, a height map shows
linear distances between positions
on the cornea and a reference
sphere. This reference sphere over
the cornea gives an idea of what
the GP fluorescein pattern may
look like.5 And so, a base curve
calculated from a tangential or
axial map could be applied as a
curvature reference sphere on a
height map to see how a corneal
GP lens may fit on the eye.
CORNEAL GP LENSES
The notable differences in shape
present between ablated and
non-ablated corneal areas after
refractive surgery can make GP
lenses challenging to fit. Often,
corneal GPs do not exhibit a classic alignment pattern on a surgically altered cornea. Instead, there
will be pooling in flatter ablated
areas and bearing over the steeper untreated areas. Nonetheless,
this may be acceptable as long as
there is adequate lens movement
and room for a healthy tear pump
behind the lens, and if the lens
does not cause any harsh areas of
punctate erosion.
Hyperopic procedures leave the
cornea highly prolate. Patients
who have had hyperopic refractive
surgery can be fit into keratoconic
lens designs.1,3 In contrast, myopic
refractive surgery will cause the
cornea to become oblate in shape;
Fig. 2. A regular geometry tricurve
corneal GP lens design on a posthyperopic LASIK eye.
Fig. 3. LASIK flap interface with
fold irregularity OS. Note the arrow,
which points towards the defect.
a reverse geometry design in which
the base curve is flatter than the
adjacent peripheral curve will align
better in oblate corneas.1,3
Iatrogenic corneal ectasia following myopic corneal refractive surgery results in anterior bulging of
the ablated cornea to cause a keratoconus-like situation. This poses a
unique challenge in fitting corneal
GP lenses because the topography
will have a combination of steeper
areas at the apex of the cone and
in the untreated periphery, and
will be flatter in the non-ectatic
ablated areas. If the apex of the
cone is central, a prolate keratoconus design lens can be fitted. In
contrast, oblate reverse geometry
designs will work better if the apex
is decentered. In cases of iatrogenic
corneal ectasia, consider a large
diameter lens (i.e., greater than
10mm), as the increased size typically centers better over broader
areas of irregularity.1
manifest refraction corrected her
to 20/20 and J1 (-0.50-0.75x035
OD and plano OS with a +2.25
add).
Prior to the LASIK procedure,
she had been a long-time monovision corneal GP wearer and
desired to have her vision corrected with this same modality. Since
she was fully corrected for distance
in the left eye, we only fitted the
Fig. 4. Tangential power corneal
topography showing oblate-shaped
OS cornea after LASIK in a patient
with flap fold irregularity.
1
Refractive Error After
Hyperopic LASIK. A
58-year-old female presented
with complaints of blurry vision
while reading at near. She had
undergone monovision hyperopic
LASIK four years prior, during
which her right eye was corrected
for near reading and her left eye
for distance. Although she presented with 20/20 distance vision OU,
she could only read J5 at near. Her
Fig. 5. Reverse geometry corneal
GP for correction of irregular
astigmatism from flap fold after
myopic LASIK.
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FITTING RIGID LENSES AFTER REFRACTIVE SURGERY
right eye. Her topography showed
a normal eccentricity value and
a topographic keratometry reading of 47.00@40/47.67@130 OD
(Figure 1). Because her eccentricity
values were normal (steep E value
of 0.64 and flat E value of 0.59),
she was fit into a regular geometry
tricurve corneal GP lens. This lens
was fit half a diopter flatter than
K. Her final lens parameters were:
46.50/+2.00/9.60 OD, and the lens
demonstrated a close-to-alignment
fluorescein pattern (Figure 2).
She reported successful wear of
this lens about three times a week
when she wanted to be free of
spectacles.
Fig. 6. Multiple stromal folds within a LASIK flap OD (left) and OS (right).
2
Flap Fold Irregularities
Corrected with Corneal
GP. A 65-year-old female
with a history of myopic LASIK
presented with complaints of light
sensitivity and glare OS while
driving at night. These symptoms
were caused by irregular astigmatism from a flap fold (Figure
3). Her vision was 20/40 with
a spectacle correction of -0.250.75x085 and her corneal topography showed an oblate corneal
shape with keratometry values of
39.09@164/39.56@074 (Figure 4).
Since her eccentricity value was
negative, a 4D reverse geometry
corneal GP with the following
parameters was trialed: 40.00/
plano/10.8. However, the lens
Fig. 7. Tangential power corneal topography showing myopic ablation profile
OU.
ultimately appeared to be about
0.75D too steep with minimal edge
lift. A new lens with a flatter base
curve and periphery was created
with an over-refraction of +0.25D.
The final lens parameters were
39.25/+1.00/10.8, and she was
able to see 20/20. This lens showed
mild apical touch and moderate
bearing in the horizontal mid-periphery (Figure 5). Nonetheless, the
lens had great movement and good
tear exchange, and the patient’s
corneal health looked great at
INDICATIONS
Patient complications following refractive surgery include
the overcorrection or undercorrection of refractive error,
anisometropia, a decentered or uneven ablation zone, flap
irregularities and the development of iatrogenic corneal ectasia.
Any of these may lead to symptoms of reduced spectaclecorrected acuity and contrast sensitivity, or ghost images.1
LASIK-induced dry eye is another common complication. While
its pathophysiology is unknown, it is believed to result from
neurotrophic epitheliopathy due to damage of the sub-basal
nerve plexus from the creation of the LASIK flap.2 GP lenses are
capable of addressing all of these concerns.
subsequent follow-up visits.
The patient was happy with her
improved visual acuity and nighttime vision and was able to wear
her lens for the entire day.
SCLERAL LENSES
In contrast to fitting corneal GP
lenses—a process in which corneal topography is crucial to lens
design—a scleral lens has the
advantage of being able to vault
the cornea and rest on the anatomy of the scleral-conjunctival area.
This makes scleral lenses ideal for
fitting over highly irregular corneas
after refractive surgery, such as in
the case of uneven ablation zones
or iatrogenic corneal ectasia. These
large lenses center well and offer
stable vision and good comfort;
additionally, their fluid-filled reservoir offers therapeutic applications
in the case of LASIK-induced dry
eye.6 Scleral lenses are available in
both regular and reverse geometry
designs.
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Fig. 8. A 16mm diameter scleral lens with a toric peripheral haptic over
patient with multiple folds of LASIK flap.
3
Flap Fold Irregularities
Corrected with Scleral
Lens. A 31-year-old male
presented to the clinic with
complaints of seeing glare around
lights and decreased vision OU for
the past year. The patient has a
history of myopic LASIK OU and,
within a week of undergoing the
procedure, reported being aware
of his symptoms. Anterior biomicroscopy revealed multiple LASIK
flap folds OD>OS (Figure 6).
His manifest refraction was
plano-1.00x065 OD and plano OS, which corrected him to
20/50 and 20/25, respectively.
Corneal topography indicated a myopic ablation profile
with keratometry readings of
38.26@012/38.71@102 OD
and 39.40@126/39.00@036
OS (Figure 7). A 16mm 4.00D
reverse geometry scleral lens with
a 42.00D base curve and plano
power was trialed in both the
right and the left eyes. The lens
demonstrated excessive vault of
500µm upon insertion over the
central corneal surface, and the
lens decentered inferiorly OU.
Overrefraction values of -9.50D
and -7.50D were found in the
right and left eye, respectively,
which led to the 20/30 OD and
20/20 OS visual acuity. As such,
the following flatter lenses with
compensated powers were ordered: 40.00/-8.50/16.0 OD and
40.00/-6.75/16.0 OS with a 2.00
D peripheral haptic OU (Figure 8).
Following dispensing, the lenses
centered well and had approximately 250µm of vault centrally
after 40 minutes of allowance
for settling OU. The lenses were
dispensed to the patient and he reported less glare and better quality
of vision in both eyes at the threeweek follow-up appointment. The
patient also had healthy corneas
and noted being able to wear the
lenses comfortably for 12 hours.
4
Intacs and LASIKInduced Dry Eye
Syndrome. A 54-year-old
male with a history of myopic
LASIK OS presented to the clinic
having formed subsequent iatrogenic corneal ectasia and dry eye
four months after the procedure.
Additionally, he had undergone
intracorneal ring segment implantation in his right eye. The
patient admitted to using preservative-free artificial tears once
every hour to treat his dry eyes.
His keratometry values were
47.25@032/43.12@125. Though
he was corrected to 20/25 with
a spectacle prescription of -4.252.50x140, he desired to be free of
glasses.
Due to his dry eye syndrome,
he wanted to try a scleral lens to
gain some symptomatic relief. A
45.00/-1.50/18.0 lens was trialed
and with a -1.00 over-refraction,
the patient could see 20/20. This
lens also demonstrated adequate
vault over the limbus and aligned
in the periphery (Figure 9). A final
lens was ordered with the parameters of 45.00/-2.50/18.0. The patient reported improved nighttime
vision and was able to decrease his
drops to application once every
four hours.
5
Lagophthalmos
Complicates LASIKInduced Dry Eye
Syndrome. A 73-year-old female
with a history of myopic LASIK
Fig. 9. An scleral lens fit on a patient
with iatrogenic corneal ectasia and
dry eye syndrome after myopic
LASIK OS. This patient also has
intra-corneal ring segments in place.
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FITTING RIGID LENSES AFTER REFRACTIVE SURGERY
45.00/-1.50/18.0 OS. Following
45 minutes of wear in the office,
the patient stated 60% relief of
her symptoms. A -3.00D OD
and 2.00D OS overrefraction
was added to the front surface of
the final scleral lens order. The
lenses showed good vault over the
corneal surface and aligned well
with the scleral shape of both eyes
(Figure 11). Following one month
of wear, the patient stated that
her symptoms were completely
resolved and that she had discontinued all of her topical drops.
T
Fig 10. Tangential corneal topography OU of a patient with dry eye syndrome
after myopic LASIK procedure. The patient’s dry eye symptoms were
exacerbated by lagophthalmos caused by her systemic Parkinson’s disease.
OU 14 years prior was referred
in for scleral lens fitting to treat
her severe dry eye symptoms. The
patient stated that her eyes had
remained relatively dry since her
LASIK procedure, but that the
severity of dryness had increased
three years ago with the advancement of her Parkinson’s disease.
The patient reported self-administering autologous serum drops
hourly, topical steroids BID, preservative-free artificial tears every
15 to 30 minutes, doxycycline
Fig. 11. An 18mm diameter scleral
lens with 4D reverse geometry
used to treat the LASIK- and
lagophthalmos-induced dry eye
symptoms of the patient from Figure
8. OD lens shown here.
hyclate 50mg tablets PO daily and
1,000mg of omega-3 PO daily.
Additionally, she had installed
humidifiers in all the rooms of her
house to help with her dry eye
symptoms.
Despite all of these efforts,
however, none of the treatments gave her significant relief.
Additionally, she stated that her
eyes constantly felt like they were
“on fire.” A slit lamp examination
demonstrated inferior punctate
staining and a decreased blink
rate of once every 30 seconds.
The patient was correctable to
20/20 at distance and J1 at near
with a mild hyperopic and astigmatic correction of +0.50-0.75x
040 OD and +0.50-0.75x180 OD
with a +3.00 add. Her topography
showed a myopic ablation profile
OU and keratometry readings
of 43.87@062/43.12@152 OD
and 43.75@128/41.12@038
OS (Figure 10). The following
4D reverse geometry diagnostic
scleral lenses were placed on her
eyes: 46.00/-2.00/18.0 OD and
hough most patients who
undergo refractive surgery exhibit good visual outcomes, there
are still some who need to wear
contact lenses afterwards to rehabilitate their vision and/or health
of their eyes. Fitting contact lenses
after these procedures can be
challenging due to altered corneal
shape and unenthusiastic patient
attitudes about wearing lenses
again. Knowledge of the various
contact lens designs and the ability
to interpret corneal shape after
LASIK and PRK is key to helping
this population succeed in contact
lens wear. In most cases, GP lenses
are a great choice and offer relief
for surgically altered corneas.
RCCL
1. Steele C and Davidson J. Contact Lens fitting
post-laser-in situ keratomileusis (LASIK). Contact
Lens and Anterior Eye. 2007 May;30(2):84-93.
2. Garcia-Zakisbak D, Nash D, Yeu D. Ocular
Surface diseases and corneal refractive surgery.
Current Opinions in Ophthalmology. 2014
Jul;25(4):264-269.
3. Gruenauer-Kloevenkorn C et al. Varieties of
contact lens fittings after complicated hyperopic
and myopic laser in situ keratomileusis. Eye and
Contact Lens .2006 Sep;32(5):233-39.
4. Szczotka-Flynn L, Jani BR. Comparison of
axial and tangential topographic algorithms for
contact lens fitting after LASIK. Eye Contact Lens.
2005;31:257–62.
5. Rabinowitz YS. “Corneal Topography: Corneal
Curvature and Optics, Clinical Applications,
and Wavefront Analysis ” Clinical Contact Lens
Practice. ES Bennett, BA Weissman. Philadelphia,
Lippincott Williams & Wilkins: 215-32.
6. Parminder A, Jacobs DS. Advances in scleral
lenses for refractive surgery complications.
Current Opinions in Ophthalmology 2015
Jul;26(4):243-248.
20 REVIEW OF CORNEA & CONTACT LENSES | JUNE 2016
016_RCCL0616_F2_GP-PostRefractive.indd 20
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4/28/16 1:49 PM
Unusual Clinical Cases
in
Orthokeratology
For the right patient, these lenses may be life-changing. Two challenging
cases provide insights into the fitting process. By Daddi Fadel, DOptom
T
he use of custom rigid
lenses to reshape the
cornea is increasingly
prevalent throughout
the world, albeit more
so in Asia than in Europe and
the United States.1-3 Therapeutic
orthokeratology lenses are typically
fit in Europe to eliminate the need
for glasses or contact lenses, while
in Asia they are primarily used to
control the progression of myopia.1
Europe’s orthokeratology fitting
process employs corneal topography with a software-based approach that is supplemented with
trial lenses. This is achieved via the
manufacturing of contact lenses by
a third party, so the practitioner’s
knowledge of back surface parameters remains limited. In Asia,
however, the fitting process for orthokeratology incorporates topography, trial lenses and fluorescein
pattern evaluation, meaning practitioners typically achieve a greater
amount of confidence and success
with the fitting process, though this
is not always the case. This article
will discuss the orthokeratology
lens fitting process in the context
of calculating back lens parameters
individually for unusual cases.
1
TEENAGE PATIENT
Presentation. A 17-year-old
patient underwent an orthokeratology fitting to control her
myopic progression, as her mother
had myopia in both eyes corrected
with eyeglasses (sph -18D). She
presented with moderate myopia
(-5.50D), a steep and small cornea
and a medium-to-low eccentricity
value. Her refractive and corneal
data were as follows: Rx sph -5.50
cyl -0.50x175° BCVA 20/20, Ks
7.26/7.09mm, average corneal
eccentricity E = 0.24, horizontal
visible iris diameter 10.60mm and
pupil size 3.60mm in the right eye;
and Rx sph -5.00 cyl -0.50x10°
BCVA 20/20, K 7.24/7.03mm, average corneal eccentricity E = 0.30,
horizontal visible iris diameter
10.70mm and pupil size 3.70mm in
the left eye.
For this patient, the prescribed
lens back surface exhibited a tetracurve design with a back optic zone
(BOZ); a first peripheral zone or
reverse curve steeper than the BOZ
(BPZ1); a second peripheral zone
or landing zone flatter than the
previous one (BPZ2); and a third
peripheral zone steeper than the
second one (BPZ3). This approach
uses one of several different modern reverse orthokeratology lens
designs available on the market.
In theory, more curves could occur
to smooth the junction’s angle
between one curve and another to
produce conformal periphery and
to increase the lens centration.
Methods. When choosing the
back optical zone radius (BOZR)
for the first trial lens, it’s possi-
ble to use different formulas.4-7
Additionally, instead of selecting
the BOZR, it’s possible to use sag
fitting methods.7,8 The indications
to calculate these orthokeratology
lens parameters (using the Jessen
Factor formula) are demonstrated
in Table 1, while the parameters
of the first pair of lenses fit on the
patient in question are shown in
Table 2. For the purpose of this discussion, however, it is not relevant
which formula is used to calculate
the first lens back surface parameters, because the final parameters
were revised after evaluating the
lens fit on the eye as well as its
position, its movement and its fluorescein pattern.
In comparing these parameters
with those indicated in the literature, note that the chosen BOZR
is 0.36mm shorter; from this, a
residual refractive error of 1.75D
in the right eye (OD) and 1.25D in
the left eye (OS) was then expected. Additionally, the BPR1 was
longer with a lower inversion than
ABOUT THE AUTHOR
Dr. Fadel specializes in fitting
contact lenses for the
irregular cornea as well
as in scleral lens fittings
and orthokeratology. She
has a contact lens private
practice in Italy where she
designs special customized
contact lenses. She lectures and
publishes especially on the
aforementioned subjects. She can be reached
at [email protected].
22 REVIEW OF CORNEA & CONTACT LENSES | JUNE 2016
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Fig. 1. Fluorescein patterns of the first pair of lenses, three nights after
initiation of treatment. Note, the steep pattern of the lenses is clear.
normal, while the BPR2 was longer
than 0.40mm; this could mean a
possible lifting of the optical zone
with modest result in the treatment.
Additionally, note that the lens is fit
steeply with central corneal staining most visible after lens removal
(Figures 1 and 2). Corneal topography demonstrated the typical
central islands that can be induced
from a steep lens.
Following this evaluation, new
lenses were calculated based on the
parameter analysis of the first trial
lenses and the fluorescein pattern.
The BOZ was flattened according
to calculations made previously,
which automatically increased the
reverse curve, leaving the same
BPR1 (Table 3). The BPZ2 was
also flattened to allow a lifting of
the optical zone to prevent corneal
abrasions and allow for a better
distribution of epithelial tissue.
Results. Five days after the pa-
Fig. 2. Note the corneal staining in
the central area.
has suggested that low corneal
eccentricity is predictive of a lower
refractive error change. As such,
these results are in agreement
with other studies demonstrating
that low eccentricity may not be
an absolute contraindication to
orthokeratology, despite the fact
that the patient’s cornea was small
and steep with a medium-to-high
degree of myopia.8-12 In these cases,
the corneal shape becomes oblate
due to the negative eccentricity
(i.e., E = -1.62 OD and E = -1.50
OS). In the case of this patient, her
issue was resolved using a fourcurve reverse lens with a mean
back optic zone diameter and
relatively small total diameter.
tient was fit with an orthokeratology lens, her UDVA was 20/25+2
OD with residual refractive errors
present in the spectacle plane sph
-1.00D and 20/20 OS with residual refractive errors sph -0.50D.
Twenty days after the fitting, the
patient’s UNVA was 20/16-1 OD
with residual refractive errors: sph
-0.25D; 20/16 OS with no residual refractive errors; and 20/12.5
in both eyes (OU). The patient
reported having good vision with
the lenses for up to 15 hours per
day, but complained that she sometimes observed visual halos around
lights. At her three-and-a-half
month follow-up appointment, the
UDVA was 20/16 OD with residual refractive errors sph -0.25D
and 20/16 OS with no residual
refractive errors. The low contrast
UNVA was 20/25 OD, 20/25 OS
and 20/12.5 OU.
Discussion. Previous research
2
CONTACT LENS
DROPOUT
Presentation. A 48-year-old
patient presented to the clinic wishing to try wearing orthokeratology
Table 1. Tetracurve Lens Parameter Calculations for Myopia up to 4.25D14
Tetracurve RGL for Myopia < -4.25D
(Jessen Factor (JF) 0.50 - 1.00D
BOZR = Kp + m. target + J.F.
BOZR = 7.25 + 1.15 + 0.15
BOZR = 8.56mm
BOZD = 5.80 - 6.40
BPR1 = 6.00mm
BOZD = BOZR-2x/2.6x(m.t.+J.F.)
BPR1 = 8.56 - 2 x (1.15 + 0.15)
BPR1 = 5.96mm
BPR2 alignment with peripheral cornea
BPR2 = K
• 0 < e < 0.30
• 0.31 < e < 0.55 BPR2 = K + 0.05mm
• 0.56 < e < 0.70 BPR2 = K + 0.10mm
BPR2 = 7.20mm
W2 = 1.0 -1.3mm
W2 = 1.2mm
BPR3 = 10.5 - 12.5mm
BPR3 = 10.5mm
W3 = 0.4mm
W1 = 0.4 - 0.6 mm
TD = 10.0 - 11.50mm
W1 = 0.6mm
TD = 10.4mm
*The spherical equivalent was considered as the myopic target (-5.75D) and Jessen factor value of 0.75D.
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UNUSUAL CLINICAL CASES IN ORTHOKERATOLOGY
Table 2. Parameters of the First Pair of Lenses Fit in Case 1
Kf
Ks
OD
7.26
7.09
OS
7.24
7.03
Inv. 1.8
BOZR
BOZD
BPR1
W1
BPR2
W2
BPR3
W3
OD
8.20
6.00
6.40
0.60
7.60
1.15
10.0
0.50
OS
8.20
6.00
6.40
0.60
7.60
1.15
10.0
0.50
TD 10.50mm; BVP +0.50D.
lenses to eliminate the need for eyeglasses. She had previously worn
soft contact lenses, but had stopped
due to resulting dry eye symptoms.
Her refractive and corneal data at
the time of presentation was Rx
sph -0.75 cyl -2.50x170° BCVA
20/16 Add 1.50D, K 7.81/7.49mm,
E = 0.10, horizontal visible iris
diameter 11.60mm and pupil size
3.40mm OD; and Rx sph -1.50 cyl
-1.50x20° BCVA 20/16 add 1.50D,
K 7.51/7.29mm E = 0.20, horizontal visible iris diameter 11mm and
pupil size 3.50mm OS.
It was noted the patient’s cylindrical component was three times
larger than the spherical one in the
right eye, while in the left eye they
were equal. Also, there was refractive astigmatism (cyl -2.50 OD and
cyl -1.50 OS higher than corneal
Potential Orthokeratology Contraindications
A better understanding of lens parameters and fitting
techniques may allow practitioners to beat some of these typical
orthokeratology contraindications:
1. Myopia correction up to -6.00D, due to a lack of predictability of
the treatment.8,12
2. Correction of with-the-rule corneal astigmatism higher than
1.50D.22-25 The most common problem in patients with high corneal
astigmatism is spherical lens decentration, which can lead to further
induced astigmatism and poor vision.24,26
3. Correction of against-the-rule and oblique corneal astigmatism
higher than 0.75D.18,19,25,26 This is due to lens decentration, which can
induce more astigmatism.24,26
4. Correction of corneal astigmatism. Residual astigmatism can
affect refractive outcomes post-treatment.27
5. The need for spectacle lens cylinder to always be less than the
spherical power (i.e., less than one-third of the sphere).8
6. Astigmatism spanning limbus-to-limbus because of lens
decentration.8
7. Irregular corneal astigmatism, given the difficulty to stabilize the
lens on the cornea.8
8. Pupil size of about 5mm to 6mm or larger under dim light
conditions.12 Orthokeratology can induce higher-order aberrations,
especially spherical aberrations. In patients who have a pupil size
greater than 5mm, the amount of high order aberrations increases
dramatically.
9. Low corneal eccentricity, in that the correlation between
eccentricity and the predictability of the treatment is not well
defined, so orthokeratology is only considered safe for correction of
myopia less than -4.00D.8,12
astigmatism (i.e., -1.82D OD and
-1.39D OS) and low eccentricity
present. Additionally, though the
patient’s marginal dry eye was not
an absolute contraindication to
orthokeratology lens wear, it could
challenge the practitioner’s ability
to create a reliable topography
map, since corneal topographers
are typically more effective at generating a clear image when evaluating a wetter corneal surface.12
Few published studies currently
exist on the subject of toric orthokeratology for astigmatism, though
conference abstracts and case
reports on the subject are numerous.13-21 One study was conducted
on patients who have astigmatism
greater than 1.25D at any orientation.13 The lenses used in this
project contained five toric zones
with double reverse curves, with
the second and the fourth zones being the reverse ones. This design is
known as a full toric double reservoir. The researchers suggested that
to achieve an adequate effect with a
toric orthokeratology lens, mechanical and hydrodynamic forces
must occur in different ways in
each corneal meridian, with greater
flattening in the meridian where the
myopia is greater.20 Results demonstrated an 85% change in initial
astigmatism.
Another study on patients
ranging from six to 12 years old
with myopia of 0.50D to 5.00D
and with-the-rule astigmatism of
1.25D to 3.50D incorporated a
lens characterized by an alignment
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Table 3. Comparison of the First and Second Pair of Lenses in Case 1
Kf
Ks
OD
7.26
7.09
OS
7.24
7.03
BOZR
BOZD
BPR1
W1
BPR2
W2
BPR3
W3
OD
8.20
6.00
6.40
0.60
7.60
1.15
10.0
0.50
OS
8.20
6.00
6.40
0.60
7.60
1.15
10.0
0.50
TD 10.50mm; BVP +0.50 D
BPR2 = BOZR - 2x/2.6x (m. t. + J.F.)
BPR1 = 8.20 - 2 x (1.15 + 0.15)
BPR1 = 6.00mm (inv. 2.6 mm)
Kf
Ks
OD
7.26
7.09
OS
7.24
7.03
Inv. 2.2/2
BOZR
BOZD
BPR1
W1
BPR2
W2
BPR3
W3
OD
8.60
6.00
6.40
0.60
8.00
1.15
10.0
0.50
OS
8.40
6.00
6.40
0.60
8.20
1.15
10.0
0.50
TD 10.50mm; BVP 0.00D.
toric zone with spherical back optics and a reverse zone design.14,15
According to the authors of this
study, the advantage of placing a
spherical optic zone on a toric cornea is that the flattest lens meridian
creates a normal orthokeratology
effect, while the steepest meridian
results in a greater orthokeratology
effect, leading to the correction
of the corneal astigmatism. The
study results demonstrated a fit
success rate of 95% with a significant reduction in myopia and
astigmatism.
Some of the case reports in existence in which authors fit different
toric orthokeratology lens designs
include:
• A case of a 22-year-old patient,
sph -4.25 cyl -3.75x8° OD. The
corneal astigmatism (CA) was
-3.10x7°, and the lens used had
two toric zones: the reverse and the
landing zone.19 The reduction of a
high CA can be achieved if the reverse zone design allows for a close
tangential or alignment in each meridian to properly modulate the hydrodynamic forces, which enables
for the flattening of each meridian
to establish the orthokeratology
effect. In the presented case, at two
months post-treatment the CA was
largely reduced, and the subjective
correction was cyl -0.50Dx8° with
UNVA 20/20.
• A case of a 44-year-old patient
with a mixed astigmatism in which
the cylindrical component was
greater than spherical one. The
patient presented with sph + 1.00
cyl -2.00x180° OD and sph +1.25
cyl -2.25x180° OS.20 The lens fit
Fig. 3. Fluorescein patterns of the second pair of lenses, 20 days
post-orthokeratology. Both lenses are decentered, compromising the
refractive outcome.
on this patient was a hexacurve
(i.e., six back curves) design with
two back toric zones, dual toric
zones and optical and landing
zones. Also, the vertical meridian
was steeper than the horizontal
meridian in the landing zone and
vice versa in the optical zone. Three
months post-orthokeratology fitting, the subjective correction was
sph + 0.50 cyl -0.50x10° (UNVA
20/16) OD and sph+0.25 cyl
-1.00x5° (UNVA 20/16) OS.
Methods. Because there do not
appear to be any set guidelines for
toric orthokeratology lens parameter calculation in the literature,
indications for spherical orthokeratology lenses were followed
instead. The first pair of lenses used
demonstrated a tetracurve design
with two toric zones—one in the
optical zone to correct the astigmatism and another in the landing
zone to help achieve a centered
lens. Parameters are listed in
Table 4.
Fluorescein patterns for this lens
fit demonstrated the presence of an
upward decentration in the right
eye, while in the left eye the pattern
was suitable as the BPZ2 was
aligned over the corneal peripheral
meridians. The spectacle correc-
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UNUSUAL CLINICAL CASES IN ORTHOKERATOLOGY
Fig. 4. Fluorescein patterns of the third pair of lenses, 20 days postorthokeratology. In this instance, the lenses were centered.
tion was OD sph +1.00 cyl -1.25
x 145°(UNVA 20/32) and OS cyl
1.00 x 40° (UNVA 20/25). Once
the treatment effect was underway
in the left eye, the design was maintained via flattening of the BOZ by
0.2mm in the horizontal meridian.
The second pair of lenses was
calculated and a tetracurve lens
with three toric areas—the optical zone, the reverse zone and the
landing zone—was selected based
on the residual refraction with the
first lenses (Table 5). Fluorescein
patterns and corneal maps post-fit
demonstrated lens decentration in
both eyes, leading to poor refractive results and visual acuity (Figure
3). Parameters were sph +1.00 cyl
-1.25x145°(UNVA 20/32) OD and
cyl -1.00x40° (UNVA 20/25) OS.
Next, a third pair of lenses was
ordered; the parameters are shown
in Table 6. It should be noted that
the majority of new lens parameters do not necessarily respect the
indication reported in literature for
spherical orthokeratology lenses.
For example, the width of the
reverse zone (W1) was larger than
the landing one (W2) to achieve a
greater hydrodynamic force action,
allowing a higher closing lens in
each meridian to increase the effect
of orthokeratology. For the lens
stability, it was decided that the
BPZ2 should be flatter than K. In
this case, the BPZ3 was steeper
than most literature indications to
allow for a tear exchange, and the
width of the third peripheral zone
(W3) was the same as W2 to help
balance corneal touch around all
meridians.
Results. Twenty days post-treatment, the fluorescein patterns
looked good, with regular and
constant (real or apparent) touch
in all the corneal meridians (Figure
4). The corneal profile post-orthokeratology is shown in the corneal
maps (Figure 5). The subjective correction was cyl -0.75x150° (UNVA
20/16) OD, cyl -0.50x30° (UNVA
20/16-1) OS and UNOU 20/16.
The patient demonstrated good
UNVA for more than 13 hours a
day. Additionally, topoaberrometry
showed that corneal higher-order aberrations were not relevant
except the spherical ones, which
allowed the patient to have a good
VA at different distances and hence
setting up close.
The slit lamp examination
showed instability of the tear
film in both eyes but the patient
reported no presence of symptoms
throughout the day.
Discussion. As seen before, in
the published studies, conference
abstracts and case reports, there
are a number of designs of toric
contact lenses to treat astigmatism
that work equally well.13-21 This
second case was solved using a
four-toric zone reverse lens, even if
it was an apparently contraindicated scenario for this type of lens. In
fact, the cylindrical component in
the OD was three times larger than
the spherical one, while in the OS
they were equal. Also there was a
refractive astigmatism (OD -2.50D,
OS -1.50D) higher than CA (OD
-1.82D and OS -1.39D) and a low
eccentricity. The parameters of the
back curve were then calculated
manually.
T
hough FDA approval criteria
states that orthokeratology
is appropriate for myopia correction up to -6.00D, there is enough
evidence to suggest that orthokeratology also has function for higher
myopia and astigmatism. As such,
the orthokeratology fitting process
Table 4. Parameters of the First Pair of Lenses Fit in Case 2
Kf
Ks
OD
7.81
7.49
OS
7.51
7.29
Inv. 1.8
BOZR
BOZD
BPR1
W1
BPR2
W2
BPR3
W3
OD
8.25/8.10
6.20
7.40
0.70
8.15/8.00
1.10
11.10
0.50
OS
7.90/7.75
6.20
7.15
0.70
7.85/7.65
1.10
10.50
0.50
TD 10.80mm; BVP +0.50D. BOZ and BPZ2 are toric.
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Table 5. Parameters of the Second Pair of Lenses Fit in Case 2
Kf
Ks
OD
7.81
7.49
OS
7.51
7.29
Inv. 1.8
BOZR
BOZD
BPR1
W1
BPR2
W2
BPR3
W3
OD
8.35/8.00
6.50
7.50/7.20
0.50
7.90/7.60
1.25
11.00
0.75
OS
8.10/7.80
6.50
7.35/7.15
0.50
8.10/7.90
1.25
11.00
0.75
TD 11.50mm; BVP 0.00D.
Table 6. Parameters of the Third Pair of Lenses Fit in Case 2
Kf
Ks
OD
7.81
7.49
OS
7.51
7.29
Inv. 1.8
BOZR
BOZD
BPR1
W1
BPR2
W2
BPR3
W3
OD
8.00/7.70
6.30
7.60/7.30
0.80
7.90/7.60
0.70
9.00
0.70
OS
8.00/7.90
6.50
7.50/7.30
0.70
8.10/7.90
0.60
9.00
0.60
TD OD 10.70; OS 10.30mm; BVP 0.00D.
in these instances could be made
easier with the knowledge of all
the lens’ back surface parameters.
It enables the contact lens practitioner to become more familiar
with the functionality of each
parameter so that it can easily be
changed to further improve the
lens fit. These cases also suggest
that a “simple” tetracurve lens
could be considered as an option
to resolve complex cases as well.
RCCL
1. Chetty E, Jackson S, Mitton C, Phillips TK. A
look at important issues regarding safe orthokeratology. The South African Optometrist,
December 2007.
2. Morgan PB, Woods CA, Tranoudis IG, Helland
M. International contact lens prescribing in 2014.
Contact Lens Spectrum 2015 January; 30: 28-33.
3. Morgan PB, Woods CA, Jones D, et al. Interna-
tional contact lens prescribing in 2012. Contact
Lens Spectrum 2013 January; 28: 31-44.
4. Luk BMW, Bennett ES, Barr JT. Fitting orthokeratology contact lenses. Contact lens Spectrum
2001 October, 16(10):22-32.
5. Jessen GN. Orthofocus techniques. Contacto
1962; 6(7):200-204.
6. Chan B, Cho P, Mountford J. The validity of the
jessen formula in overnight orthokeratology: a
retrospective study. Ophtalmic Physiol Opt 2008
May;28(3):265-268.
7. Swarbrick HA. Orthokeratology review and
update. Clin Exp Optom 2006; 89; 124-143.
8. Mountford J, Ruston D, Dave T. Orthokeratology. Principles and Practice. London, Butterworth-Heinemann, 2004.
9. Mountford J. Orthokeratology. In Phillips AJ &
Speedwell L. Contact lenses. Edinburgh, Butterworth-Heinemann. 2007:423-450.
10. Joe JJ, Marsden HJ, Edrington TB. The
relationship between corneal eccentricity and
improvement in visual acuity with orthokeratology. J Am Optom Assoc 1996; 67:87-97.
11. Lui WO, Edwards MH. Orthokeratology in
low myopia. Part I: efficacy and predictability.
Contact
Lens Anterior Eye 2000;23:90-99.
Fig. 5. Corneal topographies after removing the third pair of lenses.
12. Van der Worp E, Ruston D. Orthokeratology:
an update. Optom in Practice 2006;7:47-60.
13. Paunè J, Gardona G, Quevedo L. Toric double
reservoir contact Lens in orthokeratology for
astigmatism. Eye Contact Lens 2012;38:245-251.
14. Chen C, Cheung SW, Cho P. Myopia control
using toric orthokeratology. Invest Ophthalmol
Vis Sci 2013; 54: 6510-6517.
15. Chen C, Cho P. Toric orthokeratology for high
myopic and astigmatic subjects for myopic control. Clin Exp Optom 2012;95:103–108.
16. Beerten R, Christie C, Sprater N, Ludwig F. Improving orthokeratology results in astigmatism.
Poster presented at the Global Orthokeratology
Symposium, Chicago, IL, July 29–31, 2005.
17. Baertschi M. Short and long term success with
correction of high astigmatism in OK. Poster
presented at the Global Orthokeratology Symposium, Chicago, IL, July 29–31, 2005.
18. Chan B, Cho P, de Vecht A. Toric orthokeratology: a case report. Clin Exp Optom 2009;92:387–
391.
19. Baertschi M, Wyss M. Correction of high
amounts of astigmatism through orthokeratology. A case report. J Optom 2010;3:182-184.
20. Calossi A. Mixed astigmatism treated with a
Dual-Toric ortho-k design. Contact Lens Spectrum 2013, February;28:49.
21. Jackson JM. Advanced corneal reshaping
for astigmatism. Contact Lens Spectrum 2013,
February;28:42.
22. Ruston D, Van Der Worp E. Is ortho-K ok?
Optometry Today 2004; Dec 17:25-32.
23. Chen CC, Cheung SW, Cho P. Toric orthokeratology for highly astigmatic children. Optom Vis
Sci 2012; 89:849-855.
24. Mountford J, Pesudovs K. An analysis of
the astigmatic changes induced by accelerated orthokeratology. Clin Exp Optom 2002;
85:284–293.
25. Cheung SW, Cho P, Chan B. Astigmatic
changes in orthokeratology. Optom Vis Sci
2009;86:1352–1358.
26. Chan B, Cho P, Cheung SW. Orthokeratology
practice in children in a university clinic in Hong
Kong. Clin Exp Optom 2008;91:453–460.
27. Van der Worp E. Correcting astigmatism with
orthokeratology. Contact Lens Spectrum 2006
July, 21(7):21.
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CORNEAL
CROSSLINKING
C O N TA C T
L E N S
U S E
A F T E R
An irregular cornea patient
presents needing better vision
following a corneal stabilization
procedure. What do you do?
By Boris Severinksky
Severinksky, OD
C
o
orneal
collagen crosslinking (CXL) availli
aable internationally
ffor over a decade and
now newly approved
n
in the United States, is the only
surgical procedure capable of slowing down or stopping the progression of keratoconus and secondary
keratectasia after laser in-situ keratomileusis (LASIK) and photorefractive keratectomy (PRK).1,2 CXL
is also considered by many to be a
vision-saving procedure, especially
when performed on younger patients with the goal of preventing
the need for future keratoplasty.
Research suggests CXL may have
beneficial visual and optical effects,
as evidenced by the reduction in
corneal steepness and improvement in uncorrected visual acuity
and best corrected visual acuity
(BCVA).3,4 Despite these impressive
outcomes, however, in many cases
corrective lenses are still necessary
to achieve the best possible vision
following CXL.
Specialty soft contact lenses in
particular continue to gain popularity among eye care practitioners
due to advancements in lens materials and lathing technology.5 One
such example is the silicone hydrogel mini-scleral (SHmS): a large
17mm diameter lens that vaults
the limbus and central cornea with
minimal bearing on the corneal
apex to rest on the patient’s sclera.
The lens’ central thickness varies
from 0.5mm to 0.6mm and is
responsible for the neutralization
of corneal irregularity and the
creation of a regular front refractive surface. Scleral support also
results in the formation of a true
aqueous tear lake underneath the
lens, which enhances the ability
to correct irregular astigmatism,
similar to gas permeable (GP)
scleral lenses (Figure 1). One major
indication for this type of lens is visual rehabilitation following CXL,
with the goal of the fitting being
to provide a stable, distortion-free
refractive surface and minimize
interference between the recovering ocular surface—especially the
epithelium—and the contact lens.6
Examples of custom soft contact
lenses for keratoconus include
the NovaKone (Alden Optical),
Flexlens Tricurve (X-Cel Specialty
Contacts), and Eni-Eye Soft-K lens
(Acculens).
Semi-scleral soft lenses can
also be used as therapeutic bandage lenses following refractive
or ocular surface reconstructive
surgery, especially in eyes with
high corneal toricity or steeper
than average curvature, since a
higher sagittal depth helps stabilize
lens fit and reduce excessive lens
movement. Examples include the
Kontur (Kontur Kontact Lens) or
T74/85 (David Thomas Contact
Lenses); however, the application
of these designs is limited entirely
to therapeutic purposes due to
their inability to correct irregular
astigmatism.
So, with the CXL era finally
about to begin in the US, let us
consider whether the approach to
contact lens fitting shortly after
CXL should be different from
what we consider a standard
of care for the irregular cornea
patient through a series of case
reports.
1
STANDARD PROCEDURE
A 29-year-old woman with
a diagnosis of surgically-induced keratectasia was referred in
for a specialty contact lens fitting
due to decreased vision in her left
eye for the last nine months. She
reported that she had undergone
LASIK for moderate myopia 12
years prior. The patient’s unaided
visual acuities were 20/80 OD and
20/200 OS, and her refraction was
+1.25/-3.75x140 OD and -5.00/ABOUT THE AUTHOR
Dr. Severinsky recently
completed a two-year doctor
of optometry program for
international graduates at
the New England College of
Optometry. Since 2001 he
has specialized in specialty
contact lens fitting and
especially scleral lenses. Today
his primary area of interest is designing and
fitting contact lens for keratoconus and after
corneal collagen cross-linking. He is a Fellow
of the American Academy of Optometry,
British Contact Lens Association and Scleral
Lens Education Society.
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5.00x170 OS with best-corrected
visual acuity (BCVA) of 20/30
and 20/80, respectively. Corneal
topography revealed advanced
keratectasia predominantly in the
left eye (as compared with her
right) with maximum keratometry
(Kmax) values of 55.4D OD and
59.7D OS (Figure 2). The patient
was subsequently evaluated by a
cornea specialist and scheduled to
undergo an epithelium-off corneal
collagen crosslinking procedure to
halt further progression. She was
also given temporary spectacles
with partial astigmatic correction
in the right lens and plano correction in the left to wear following
the surgery. Two weeks after, the
patient underwent CXL in her left
eye.
Five weeks later, following
complete epithelial healing and
the discontinuation of all steroid
medications, the patient’s left cornea exhibited no signs of epithelial
hypertrophy or superficial punctate
staining. As such, she was scheduled for a contact lens fitting and
given a front toric, prism-ballasted
version of the SHmS lens with
a base curve of 7.3mm and the
power of -3.75/-2.25x180. The
lens was manufactured in a Filcon
V3 silicone hydrogel material
(Definitive 74, Contamac). At the
dispensing visit, the patient’s BCVA
was 20/30 OS, with a minor complaint of ghost images. She was
instructed to increase lens wearing
Fig. 2. Corneal topography of the left
eye reveals advanced keratoectasia.
time gradually, and was scheduled
for a follow-up appointment in the
next 10 days.
During the follow-up appointment, a slight reduction in visual
acuity (i.e., 20/50) was noted, but
the patient reported noticeable
improvement in vision clarity and
her ability to perform daily tasks,
as well as good lens tolerance and
average lens wear of nine hours
a day. An examination revealed
the presence of a well-centered
lens with about 1mm of on-blink
movement (Figure 3). An overrefraction of plano/-1.50x175 was
able to improve her vision to 20/25
OS and significantly reduce the
amount of ghost images seen. A
new lens with an updated power
was ordered; three weeks later,
the patient was able to wear the
revised lens up to 10 hours a day
with stable contact lens-corrected
vision. As a result of successful
restoration of vision in the treated eye, the patient underwent an
uneventful CXL procedure eight
weeks later for her other eye.
2
PROGRESSION
PROTECTION
A 29-year-old male construction worker was diagnosed
with bilateral keratoconus
(OS>OD) 12 years prior to presenting to the clinic. He reported
he had undergone penetrating
keratoplasty in his left eye in 2011;
however, shortly after the procedure, the corneal transplant had
begun to show signs of endothelial
rejection, which eventually led
to scarring and reduced vision.
Numerous GP lens fits had been
attempted but the patient had
continued to demonstrate a severe
intolerance to rigid lenses, especially while outdoors. In the last three
years, he had successfully managed
using a soft lens made for keratoconus (Soft-K, Soflex) with param-
Fig. 1. Optimal fluorescein pattern
of silicone hydrogel mini-scleral
contact lens.
eters BC 7.00, diameter 14.20 an
power -8.00. Additionally, he had
been able to achieve a visual acuity
of 20/40-. Unaided vision in his
left eye was 20/400.
However, in early 2014 his right
eye had begun to exhibit signs of
keratoconus progression along
with a consecutive decrease in
BCVA. A new attempt to fit a GP
lens also failed. The patient was
referred to a cornea clinic for the
possible necessity of CXL, who directed him to delay the procedure
due to borderline corneal thickness
of 408µm. He was scheduled for
a follow up in six months but
later the same year, the patient’s
best-corrected vision dropped to
20/60, with marked steepening
noted on corneal topography. To
halt further deterioration of vision,
an epithelium-on CXL procedure
was performed. The postoperative
recovery was uneventful, and four
weeks later the patient had been
scheduled for contact lens fitting.
An examination at the time of
the contact lens fitting revealed
the following findings: manifest
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CONTACT LENS USE AFTER CORNEAL CROSSLINKING
with a SHmS
lens made from
Definitive 65
(Filcon V4)
rather than
the practice’s
default material (Filcon V3,
Contamac).
Filcon V4
is a polymer
with a higher silicone
content than
its predecessor,
Fig. 3. Well fitted SHms lens. Proper allocation of the
fenestration holes (at 3 and 9 o’clock) indicates absence of Filcon V3.
lens rotation.
Other than the
high oxygen
permeability (Dk = 62) previously
refraction of -5.00/-6.50x125 VA
mentioned, the Filcon V4 material
20/150 OD and -4.50/-7.50 x 110
also possesses the highest modVA 20/70 OS. Central keratomeulus of elasticity in the family of
try readings of the right eye were
lathable silicone hydrogels (MPa =
56.0/57.4D with a Kmax value of
1.0). Typically, lenses with a higher
62.5D (Figure 4). A slit lamp examination revealed a faint anterior modulus are stiffer and will correct
stromal haze with an intact corneal the underlying corneal irregularly
more effectively, while those lenses
epithelium (Figure 5). Fit assesswith a lower modulus will simply
ment using the old right contact
drape over the cornea. Fitting of
lens demonstrated an excessive
rocking movement of the lens with contact lenses with a higher modulus may be advantageous in terms
fluting edges upon blink. Attempts
of vision correction success, since
to refit the patient’s right eye with
lenses made of these materials help
a steeper Soft-K lens did not promask the entirety of corneal astigvide sufficient visual improvement
matism and eliminate the need for
(BCVA of 20/60). Instead, the paa toric design. On the other hand,
tient was selected for a trial fitting
wear of stiffer lenses can lead to
edge fluting, tarsal irritation and
mechanically-induced allergy. In
these cases, additional adjustment
of the peripheral curves is often
required for successful lens wear.
This patient was fit into a spherical version of the SHmS lens with
a base curve of 6.5mm, “steep”
peripheral curve, diameter of
17mm and central lens thickness of
0.6mm (Figure 5). The lens power
was -12.5D. Four fenestration
holes were added at the lens limbal
Fig. 4. Corneal topography of the
zone to increase oxygen delivery
right eye demonstrating a classic
and tear mixing.
keratoconic nipple cone appearance.
Vision upon dispensing was
20/50. At the one-month follow-up
appointment, the patient reported
good lens tolerance with 12 to 14
hours a day of lens wearing. Visual
acuity had decreased to 20/60,
but improved back to 20/40- with
overrefraction of +2.50/-1.50x050.
The patient’s central cornea exhibited trace central superficial punctate keratopathy, which appeared
to relate to corneal apex bearing.
A new lens with base curve of
6.4mm, similar peripheral geometry and a power of -10.5D was
dispensed. Overrefraction demonstrated similar residual astigmatism
findings of +0.50/-1.50x55. The
patient was advised to wear polycarbonate spectacles for correction
of residual astigmatism and ocular
protection. Final visual acuity of
the right eye improved to 20/30-.
No significant corneal staining or
corneal neovascularization were
present at three-month follow-up.
Current daily lens wearing time
stands at 12 hours a day with
the occasional use of lubrication
agents for comfort.
3
HYDROPS HIJINKS
Successful use of full-size
scleral lenses after corneal
crosslinking has also been previously reported in the literature.7
Regular sclerals offer the advantage of minimal mechanical interaction with the treated zone and
help promote ocular surface healing and provide optical benefits.
In this third case report, a
19-year-old male with advanced
keratoconus OS and documented
progression underwent an epithelium-off corneal crosslinking
procedure in May 2013. Prior to
the surgery, his maximum corneal steepness was 64.5D with an
unaided vision measurement of
20/800 (Figure 6a). Unfortunately,
no pre-treatment refractive data
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was available for this patient
but postoperative recovery was
positive for hypertrophic epithelium formation and delayed
healing, which was treated using
antibiotics and a bandage contact
lens during the course of four
weeks. At week five, the patient
presented back to the clinic with
complaints of significant pain
and cloudy vision OS. His vision
was reduced to CF at three feet
and severe stromal edema with
ruptures in Descemet’s membrane
was observed (Figure 7).
The patient was treated for
corneal hydrops with a five-week
course of topical steroids, in combination with antibiotic coverage
during the first seven days and
hyperosmotic eye drops. After the
patient’s cornea cleared up and the
edema diminished, the patient was
referred for a contact lens fitting.
A slit lamp examination revealed a stromal scar of moderate
density at the inferior pupillary
margin, trace punctate keratopathy of the inferior cornea, signs
of meibomian gland dysfunction
and floppy lid syndrome. Tear
break-up time (TBUT) values were
also low at seven to eight seconds.
Corneal topography demonstrated
a highly irregular corneal surface
with significant flattening of the
center and (Kmax value of ~50D) as
compared to pre-treatment findings (Figure 6b). Considering the
patient’s complex corneal geometry
and decompensated ocular surface, we decided to manage this
patient with a 18.5mm GP scleral
lens. Incorporating the advances
of reverse geometry technology,
we were able to design a lens with
a flat enough base curve to more
precisely follow an oblate central
cornea (Figure 8). The patient’s
lens-corrected visual acuity was
20/40, and, after a short adaptation period, he was able to achieve
day-long uncomplicated lens wear.
At his one-month follow-up, his
BCVA was unchanged, the corneal epithelium was intact and his
TBUT values had improved to 15
seconds.
KEEP IN MIND
Though CXL is considered a potentially vision-saving procedure in
many cases, it is not free of complications. The most common side effects are delayed epithelial healing,
longstanding SPK, noninfectious
infiltrates and stromal edema with
scarring (i.e., corneal hydrops)
as well as minimal reduction in
endothelial cell count secondary to
UV irradiation damage.8 Despite
the ocular surface complications
attributed to crosslinking, however,
the risks associated with corneal
transplantation surgery still significantly outweigh those of CXL.
Currently, there are no clear
recommendations regarding when
Fig. 6. (A) pre-treatment corneal topography of the right eye; and (b)
topography of the same eye after the resolution of corneal hydrops. Note 14D
flattening of Kmax.
Fig. 5. This image represents 6.50mm
lens with an excessive central
touch and minimal mid-peripheral
clearance. Note the presence of
the anterior corneal haze. The lens
thickness is 600µm.
it’s safe to begin or resume contact
lens wear after corneal collagen
crosslinking. Post-CXL corneal
recovery can fluctuate over time.
Crosslinking research with data on
long-term follow-up has demonstrated that corneal thickness,
as well as central keratometry,
follows a dynamic curve in the
first six months.9,10 While patients
following an epithelium-on procedure may be fitted in a time frame
of one to two weeks, patients
who undergo the epithelium-off
treatment may need a significantly
longer recovery time and may also
experience a higher rate of corneal
healing-related complications.
Though the epithelial defect
typically closes four to seven days
after the procedure, continuous
epithelial remodeling followed by
the modification in the arrangement of stromal collagen fibers
and corneal nerve proliferation
may be seen over several months.
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CONTACT LENS USE AFTER CORNEAL CROSSLINKING
Fig. 7. Corneal hydrops four weeks
after performance of the CXL
procedure in the eye with delayed
ocular surface healing.
Fig. 8. A properly fitted 18.50mm
scleral lens on the eye with resolved
post-CXL corneal hydrops. Note
the scar-induced central corneal
flattening.
Fig. 9. Dense central corneal scar
after an episode of microbial keratitis.
We assume that the infection was
propagated by the unauthorized
resumption of GP lens wear three
weeks after uneventful CXL.
Consequently, it is imperative that
healing is achieved prior to lens
fitting to avoid mechanical disruption. These changes are also reflected in the further flattening and
regularization of the central cornea,
and may often lead to improved
spectacle-corrected visual acuity
and more success with contact
lenses. For epithelium-off patients,
we recommend resuming contact
lens wear five to six weeks after
the procedure, similar to post-PRK
contact lens fitting indications.11
In the first months following
CXL, the cornea may exhibit a
thinner epithelial profile with
decreased quality of adherence
between the epithelial layers.
These changes may cause a higher
corneal vulnerability to contact
lens-induced mechanical trauma.
As such, fitting of traditional GP
lens designs may prove problematic
shortly after CXL; one of the most
frustrating cases I have encountered
recently is that of a 17-year-old
male with advanced keratoconus
(Kmax of 63D), who resumed wearing his old GP lenses three weeks
after an epithelium-off procedure.
One week later, he was admitted
to the clinic with a complaint of
significant eye pain, light sensitivity
and blurred vision in the treated
eye. Exam revealed dense infiltrative ulcerative keratitis at the center
of the left cornea. After being on
fortified cefazolin and gentamicin
for almost two weeks, the ulceration resolved but left him with a
dense corneal scar and best-corrected vision of 20/50 (Figure 9).
One study reports that patients
fit with GP lenses three months
after the procedure demonstrated
evidence of epithelial cell stress
with an increase in superficial
epithelial cell size and a decrease in
basal epithelial cell density.13 These
findings are also accompanied by a
decrease in corneal sub-basal nerve
plexus density. The other area of
concern regarding GP lens wear
after CXL is that contact lens-induced mechanical irritation may
lead to inflammation and consecutive keratocyte loss in the anterior
stroma, in addition to apoptosis
inflicted by UV irradiation.14
1. Wollensak G, Spoerl E, Seiler T. Riboflavin/
ultraviolet-A–induced collagen crosslinking for
the treatment of keratoconus. Am J Ophthalmol.
2003;135:620-7.
2. Hafezi F, Kanellopoulos J, Wiltfang R, Seiler T.
Corneal collagen crosslinking with riboflavin and
ultraviolet A to treat induced keratectasia after laser in situ keratomileusis. J Cataract Refract Surg.
2007; 33:2035–40.
3. Caporossi A, Mazzotta C, Baiocchi S, Caporossi
T. Long-term results of riboflavin ultraviolet A
corneal collagen cross-linking for keratoconus in
Italy: the Siena Eye Cross Study. Am J Ophthalmol.
2010; 149:585–93.
4. Greenstein SA, Fry KL, Hersh PS. Corneal topography indices after corneal collagen crosslinking
for keratoconus and corneal ectasia: One-year
results. J Cataract Refract Surg. 2011; 37:1282–1290
5. Fernandez-Velazquez FJ. Kerasoft IC compared
to Rose-K in the management of corneal ectasias.
Cont Lens Anterior Eye. 2012;35(4):175-9.
6. Severinsky B, Wajnsztajn D, Frucht-Pery J.
Silicone hydrogel mini-scleral contact lenses in
early stage after corneal collagen cross-linking for
keratoconus: a retrospective case series. Clin Exp
Optom. 2013;96(6):542-6.
7. Visser ES, Soeters N, Tahzib NG. Scleral lens tolerance after corneal cross-linking for keratoconus.
Optom Vis Sci. 2015;92:318-23.
8. Wajnsztajn D, Strassman E, David Landau D,
Frucht-Pery J. Ocular surface-related complications after corneal crosslinking for keratoconus.
19th Congress of ESCRS, Vienna, Austria, 2011.
9. Greenstein SA, Shah VP, Fry KL, Hersh PS.
Corneal thickness changes after corneal collagen
crosslinking for keratoconus and corneal ectasia:
One-year results. J Cataract Refract Surg. 2011;
37:691–700.
10. Greenstein SA, Fry KL, Bhatt J, Hersh PS.
Natural history of corneal haze after collagen
crosslinking for keratoconus and corneal ectasia:
Scheimpflug and biomicroscopic analysis. J Cataract Refract Surg. 2010; 36:2105–14.
11. Woodward MA, Randleman JB, Russell B, et
al. Visual rehabilitation and outcomes for ectasia
after corneal refractive surgery. J Cataract Refract
Surg. 2008;34:383–8.
12. Rocha KM, Perez-Straziota CE, Stulting RD,
Randleman JB. Epithelial and stromal remodeling
after corneal collagen cross-linking evaluated by
spectral-domain OCT. J Refract Surg. 2014;3:122-7.
13. Sehra SV, Titiyal JS, Sharma N, Tandon R, Sinha
R. Change in corneal microstructure with rigid gas
permeable contact lens use following collagen
cross-linking: an in vivo confocal microscopy
study. Br J Ophthalmol. 2014;98:442-7.
14. Kallinikos P, Efron N. On the etiology of
keratocyte loss during contact lens wear. Invest
Ophthalmol Vis Sci. 2004;45:3011–20.
I
n summary, scleral and silicone
hydrogel mini-scleral lenses in
particular continue to possess clinical importance in today’s specialty
contact lens practice. The use of
these new lens designs may become
a preferred alternative shortly after
CXL. In addition to providing
successful visual rehabilitation,
they minimize contact lens influence on epithelial remodeling and
allow uncomplicated ocular surface
recovery after the procedure.
RCCL
32 REVIEW OF CORNEA & CONTACT LENSES | JUNE 2016
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2016_rccl website house.indd 1
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CASE REPORT:
By Mohammad Tallouzi, OD
Look Before You Judge
The most unique cases sometimes present as the most mundane.
C
ontact lenses are some
of the smallest and
least visible devices for
correction of refractive error. Considered
medical devices, they can be worn
for therapeutic reasons; however,
other reasons for wearing contact
lenses exist, such as for cosmetic
purposes.1 Contact lenses are an
important part of the ophthalmologist practice, with the demand for
them increasing day-by-day; indeed,
millions worldwide currently wear
them.2 Therefore, it is also important to take precautions and educate
people when prescribing and fitting
these lenses.3
HISTORY
A 47-year-old female patient presented to the clinic with a red left
eye that had been present for the
past seven days. This was accompanied by a foreign body sensation
and watering, but no discharge.
She noted the presence of localized
swelling on her left upper eyelid
with a nodular-looking lesion. She
was treated for lid cyst with chloramphenicol ointment by the general
practitioner. Since then, however,
the condition had not improved and
so she decided to consult an eye specialist. The right eye appeared to be
without complaint or redness. The
patient was a gas permeable contact
lens wearer with her last wear time
occurring eight days ago.
The patient exhibited no other
ocular history, and her family ocular
history was negative for ocular
problems. She wasn’t taking any
systemic medications at the time of
admittance and her best-corrected
visual acuities were 20/30 OD and
20/25 OS. Pupils were round and
reactive to light, with no relative
afferent pupillary defect in either
eye. Extraocular movements were
full OU. A slit lamp examination
demonstrated that the left eyelid
was normal. Additionally, the left
conjunctiva was white and quiet;
the cornea, iris and lens were clear;
and the anterior chamber was deep
and quiet. Regarding the right eye,
a 1.0mm by 0.7mm firm nodule on
the center of the upper left eyelid
was visible, with no periorbital
erythema or edema or skin breaks
(Figure 1). The right conjunctiva
displayed hyperemic traits and the
cornea was characterized by a few
punctate epithelial erosions. The anterior chamber was deep and quiet,
the iris was round and regular and
the lens was clear.
Upon inversion of the left upper
eyelid, a circular foreign body was
made visible, surrounded by the tarsal conjunctiva (Figure 2). Attempts
to shift it with a cotton bud were
unsuccessful and subsequently, oxybuprocaine eye drops were instilled.
The object—a contact lens—was
removed using typing forceps. A
yellow pus discharge on the contact lens was observed immediately
(Figure 3). Both the lens and the
discharge was sent for culture and
sensitivity. The patient reported increased comfort, and was sent home
with topical ofloxacin eye drops
and the expectation that she would
return in three days.
Culture results indicated the
presence of Staphylococcus aureus,
which proved sensitive to the ofloxacin. The patient reported no issue
on follow-up, and was asked to
continue the drop regimen for another week. A two-week follow-up
appointment revealed everything
had healed well.
DISCUSSION
Gas permeable contact lenses (GPs)
are made of a complex polymer
that includes silicone, PMMA and
others. These lenses permit excellent perfusion of oxygen and are
used to improve vision by correcting refractive errors.4 They work
by focusing light so that it enters
the eye with the proper power for
clear vision.5 GP lenses have the
main advantage of being durable
with longer lifespans as compared
with soft contact lenses. Modern
GP lenses require a relatively short
adaptation time as compared with
older hard lenses, but patients still
need some time to get used to them.
Additionally, the size of the lenses
is beneficial as it provides for easy
insertion and the flexibility to allow
them to move freely on the eye with
each blink; however, their small size
ABOUT THE AUTHOR
Dr. Tallouzi is a surgical practitioner working
at Birmingham and Midland eye
Hospital. He specializes in
treatment of ocular surface
and inflammatory eye
diseases and was awarded
the NIHR Clinical Research
Training Fellowship in 2015.
He is currently working on
his PhD at the University of
Birmingham.
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Fig. 1. The patient presented with a
firm nodule near the center of the
eyelid of unknown origin.
can be disadvantageous as the lens
may move from its position during
daily activities or sports and be lost.
This also increases risk for debris
to become trapped underneath the
lens.
This patient in particular dislodged her contact lens from its
original position to where it sat on
the palpebral or tarsal conjunctiva.
The conjunctiva then began to fold
over the lens. The patient reported she was aware of the time she
placed the contact lens on the eye,
but that she was not aware if and
when she had lost the lens.2
C
ontact lens complications can
vary from mild irritation to
sight-threatening issues, with resulting problems leading to disturbances of the eyelids and ocular surfaces
that can result in long-term changes
and a reduction in contact lens
tolerance. In this case, the extended
wear of a GP lens led to complications that likely began as a result
of abnormal blinking of the eyelid,
ptosis due to a reduction of the
palpebral slit and meibomian gland
dysfunction.6
Other complications that might
present may relate to the tear film
and result in dry eye due to the lack
of lipids. This can lead to papillary
conjunctivitis, which is intensified
by the mechanical irritation of
the conjunctiva. Additionally, the
presence of hypoxia below the lid,
accompanied with an immuno-
Fig. 2. Everting the patient’s left eyelid revealed the presence of a GP contact
lens.
logical reaction may also induce
corneal changes like microcysts and
striae such that GPs may not allow
enough transmission of oxygen for
successful long-term extended wear.
Wear of the lens may also result in
disruption of the corneal epithelium, corneal erosion and keratitis
if not treated promptly. Corneal
edema and corneal ulcers are two
sight-threatening complications that
can occur with contact lens wear.2,7,8
Regardless of the brand of contact
lenses, however, their use requires
accompanying care to prevent
damage and avoid sight-threatening
complications. The majority of contact lens complications are caused
by careless handling and overwear
of lenses. As such, patient education
is key, as is early identification of
the above mentioned conditions so
that necessary medical help can be
sought.
RCCL
1. Farandos M, Yetisen K, Monteiro J, et al. Contact
lens sensors in ocular diagnostics. Advanced
Healthcare Materials. 2015 Apr 22;4(6):792-810.
2. Lemp M and Bielory L. Contact lenses and associated anterior segment disorders: dry eye disease,
blepharitis and allergy. Immunol Allergy Clin North
Am. 2008 Feb;28(1):105-17. vi-vii.
3. Dart JK, Saw VP, Kilvington S. Acanthamoeba
keratitis: diagnosis and treatment update 2009. Am
J Ophthalmol. 2008 Oct:148(4):487-499.e2.
4. Denniston A and Murray P. Oxford Handbook of
Ophthalmology. 2nd edition. Oxford: Oxford University Press; 2009.
5. Benjamin L. Training in Ophthalmology: The
Essential Curriculum. Oxford: Oxford University
Press; 2009.
6. Beljan J, Beljan K and Beljan Z. Complications
caused by contact lens wearing. Coli Antropol. 2013
Apr;37 Suppl 1:179-87.
7. Compan V, Andrio A, Lopez-Alemany A, et al.
Oxygen permeability of hydrogel contact lenses
with organosilicon moieties. Biomaterials. 2002
Jul;23(13)2767-72.
8. Ehler J, Shah C, Fenton G, Hoskins E. The Wills
Eye Manual: Office and Emergency Room Diagnosis
and Treatment of Eye Disease. 4th edition. Philadelphia: Lippincott Williams & Wilkins.
Fig. 3. Lens removal led to the discovery of discharge.
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Medically Necessary Contact Lenses:
Medical Plan or Vision Plan Responsibility?
BY ROBERT L. DAVIS, OD
Do you know how to work with insurance companies to
achieve the biggest bang for your buck?
F
or those patients with
certain medical conditions, contact lenses provide a distinct
opportunity to improve
patient quality of life in cases in
which corneal shape is distorted
or if a spectacle correction fails to
provide adequate vision. Visual
phenomena like glare, double vision
and sensitivity to light can make
processing images more difficult
for patients; as such, in many cases
non-elective procedures are the
only solution to recapture a normal
lifestyle. However, even when faced
with the same procedures and diagnostic codes, each vision insurance
company has its own guidelines
to determine what constitutes a
“medically necessary” contact lens.
As such, the imbalance in coverage
between vision insurance companies, coupled with rising health care
costs, often means a policy nightmare for the eye care practitioner.
Today, most medical plans are
coupled with vision care plans,
though many limit medical coverage for specialty services to just the
diagnosis of the condition and coverage of the treatment. This creates
a problem for patients seeking resolution for an ocular issue: they have
covered access to the diagnostic
services used to identify the condition and the actual medical devices
(i.e., corrective lenses) necessary to
treat the issue, but not the medi-
cal procedures (i.e., surgery and
medical treatment) they may have
to undergo to enable the treatment
to work. Ultimately, for patients to
benefit, the medical portion must
be covered under both the vision
care and medical care sides of an
insurance plan.
INDICATIONS AND OPTIONS
As specialty lenses are indicated
primarily for patients with irregular corneas (e.g., in the case of
keratoconus, pellucid marginal
degeneration, scarring, post-surgical
corneal abnormalities), gas permeable materials figure prominently in
the approach to care. GPs provide
a rigid surface that neutralizes the
corneal irregularity, in effect replacing it with the controlled regular
surface of the lens. Some conditions
are better served by sclerals rather
than corneal GP lenses due to their
design with an elevated dome and
haptic zone that vaults the cornea
to land on the sclera, respectively.
Hybrids that combine a GP center
with a soft lens periphery may be
also be possible to improve comfort
while custom soft lenses may suffice
for some patients.
Beyond irregular cornea indications, specialized custom contact
lenses are typically also appropriate for most medically necessary
criteria like:
• Binocular vision issues caused
by the presence of nystagmus, an-
seikonia and anisometropia, as well
as glare and light sensitivity resulting from aniridia and anisocoria.
• High myopic or hyperopic prescriptions if visual improvement (as
defined using Snellen acuity) with
contact lenses surpasses that which
is possible with spectacle wear.
• Lens use following refractive
surgery and other traumatic cases,
in which improved visual acuity can
be demonstrated with lens wear.
However, some disputes remain
regarding insurance coverage.
Though patients and/or health care
providers may define a condition as
medically necessary, guidelines for
a specific health care plan may not
agree.
Consider, for example, the role
of scleral lenses. The lens design
includes a fluid compartment
underneath the lens’s surface to
keep the cornea hydrated; as such,
ABOUT THE AUTHOR
Dr. Davis practices in Oak Lawn,
Ill., where he is the director
of the contact lens clinic at
Davis EyeCare. He is also
a co-founder of EyeVis
Eye and Vision Research
Institute, where he works
developing contact lens
designs and furthering research
on anterior segment pathophysiology. Dr. Davis has been recognized as a
diplomate in the corneal, contact lens and
refractive technology section of the American
Academy of Optometry and is an inductee in
the National Academy Practice in Optometry
as well as an advisor to the Gas Permeable
Lens Institute and a recipient of the Gas
Permeable Practitioner of the Year Award. He
has also been honored as one of the 50 most
influential optometrists in 2015.
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Table 1. A Comparison of Medically Necessary Contact Lens Vision Care Plans
Condition
EyeMed
Davis
VSP
Superior
Humana
>3.5D with
diplopia or
With specs. >3.5D.
aesthenopia.
Anisometropia
3D in any meridian.
≥4D BVA ≥ 20/40
Intact epithelium.
3D
4D and VA
improves
≥20/60
High
Ametropia
±-10D
±-8D
±-10D
±-10D
Keratoconus
Not correctable to
20/25 Two lines
better than 20/25.
K readings or topography BVA ≤20/40
Two lines improvement. Absence of
hydrops. Intact epithelium.
K readings,
OCT or topography.
Topography or K
readings
and notes.
Corneal
Ectasia
Achieve comfort
and/or vision correction not possible
with mid- to moderate keratoconus.
Suitable for contact
lens applications.
Vision
Improvement
Spectera
Two lines
improvement. With
documentation.
Acuity
<20/70 in
spectacles
and better
than 20/70
in contact
lenses.
Two lines better
than specs.
Aphakia
BVA ≥20/100 Aphakia
without implant. No
corneal or vitreous
Included.
opacity. Intact macula. Intact epithelium.
Aniseikonia
Unequal image size
between the two
eyes. Intermittent
or constant diplopia. Less than 100
degrees stereopsis.
Intact epithelium.
Aniridia
Surgical or traumatic.
Irregular
Astigmatism
≥2D principle meridians are separated <
90 degrees. Two lines
of improvement. BVA
<20/70.
Glasses
provided
together
with contact lenses.
Doctor
must
certify that
contact
lenses are
medically
necessary.
Included.
Nystagmus
Included.
Corneal
Transplant
Included.
Corneal
Dystrophy
Included.
Colored
Contact Lenses
For achromatopsia, albinism, aniridia,
anisocoria, or
polycoria pupil
abnormality.
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MEDICALLY NECESSARY CONTACT LENSES
these lenses are well-suited for the
treatment of severe ocular surface
diseases like corneal stem cell deficiency, Stevens-Johnson syndrome,
chemical and thermal injuries to the
eye, ocular pemphigoid, neurotrophic corneas, severe dry eye from
Sjögren’s syndrome, chronic graftversus-host disease, ocular radiation, corneal exposure and corneal
disorders associated with systemic
autoimmune diseases such as rheumatoid arthritis. The question is,
however, whether these are medical
conditions, or whether they covered
under primary vision care. It often
varies among providers.
TAKING RESPONSIBILITY
Most health care plans determine
the criteria for their respective
covered population. For example,
contact lenses for masking irregular astigmatism associated with
keratoconus and other corneal
disorders requires certain documentation from the initial exam and
follow-up visits to cover requests
for coverage.1 Additionally, the
patient’s first visit to the clinic must
include a comprehensive eye exam,
performance of advanced corneal
topographic modeling or keratometry and documentation of the lens
fitting process.1 Failure on the part
of the practitioner to adhere to
these criteria may lead to disqualification from reimbursement.
Table 1 correlates the different
covered conditions with corresponding vision care plans. Note
that each offers different coverage
for different conditions; uniformity
is rare and should not be expected.
As such, it is the responsibility of
the practitioner to inform the insurance carrier of the needs of their
patient population.
Because we live in an era where
most doctors are held accountable
for their actions—including and
especially billing policies—proper
documentation is the best way to
guarantee passing an audit and
receiving payment for the work
provided. As such, the contact lens
fitting, dispensing and follow-up
visit must each be separately documented in the practice’s medical
records, with a thorough record
made of all services provided.
This includes patient pick-up of a
reordered contact lens prescription
or other ancillary events that may
occur later on.
Typically, records should include
the prescription, number and material type of contact lenses dispensed;
patient lens wear and replacement
schedule; recommended care and
cleaning instructions; any data
from the fitting appointment; visual
acuity measurements taken both
through the lenses and overrefraction; and the date the final lenses
were dispensed. Additionally,
practitioners should ensure they
have a documented contact lens
history on file. This should include
information on the use and care of
the patient’s lenses in their work
environment; hobbies and daily
routines; previous lens experience
and any type of lens accoutrement
used.
The patient’s lens fit and evaluation appointment should include
keratometry or topography, with
proper diagnosis made if a corneal
anomaly like corneal distortion or
an ectatic disease is initially suspected. Recorded observations from
a slit lamp should document both
views with a diagnostic contact lens
for the purpose of assessing fit and
the patient’s eye sans-lens to assess
the ocular health of the cornea,
conjunctiva, sclera, tear film and
eyelids. Overrefraction with the
contact lenses should be recorded
monocularly, with visual acuities
noted for each trial lens tested,
Table 2. EyeMed Insurance Coverage for Contact Lens Wearers
Test
New Wearer
Existing Wearer
Contact Lens-Related History
Required
Required
Keratometry and/or Corneal Topography
Required
Required
Anterior Segment Analysis with Dyes
As Indicated
As Indicated
Biomicroscopy of Eye and Adnexa
Required
Required
Biomicrscopy with Lens: Fluorescein Pattern (Rigid Lenses) or
Orb Movement and/or Centration (Soft Lenses)
Required
As Indicated
Overrefraction
As Indicated
As Indicated
Visual Acuity with Diagnostic Lenses
Required
As Indicated
Determination of Contact Lens Specifications Determined to
Obtain the Final Prescription
As Indicated
As Indicated
Member Instructions and Consultations
Required
Required
Proper Documentation with Assessment and Plan
Required
Required
38 REVIEW OF CORNEA & CONTACT LENSES | JUNE 2016
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as well as the final contact lens
prescription. A short narrative assessment of the patient’s subjective
response and/or the doctor’s objective response regarding the state
of the contact lens ordered should
also be written; this should include
comments on the clinical findings,
impressions and diagnosis.
Additionally, practitioners should
add notes on their planned treatment plan to the patient’s file, with
information like the contact lens
materials and parameters included.
Dispensing visit documentation
should contain instructions prescribed to the patient for their lens
care regime, handling and wear
schedule. Finally, a description on
the patient’s ability to apply and
remove the contact lenses, as well as
financial records relating to the ordering of the final lens prescription
and a comment regarding whether
the contact lenses were dispensed
from stock for record-keeping
purposes may also be prudent to
include.
Records taken at follow-up appointments of the patient’s progress
should document their positive and
negative comments related to wearing the lens, as well as the patient’s
report of their level of compliance
with practitioner instructions.
Notes on the patient’s advances in
their lens wear should include monocular acuities and overrefraction as
well as slit lamp observations documenting the lens on the cornea and
the health of the corneal surface
and surrounding tissues. Finally,
any new clinical findings or changes
in lens care, wearing or replacement
recommendations should be written
down for the purposes of updating
treatment plan records. When documenting medical necessity, it may be
useful to include pachymetry, specular microscopy, tear film assessment
including osmolarity, InflammaDry
scores, staining assessment with
both NaFl and lissamine green,
meniscus height, tear break-up time
and the status of the meibomian
glands.
Table 2 lists an example of one
company’s (EyeMed) test requirements for provision of coverage
to new and existing contact lens
wearers. In comparison, other
companies require itemized financial records for medically necessary
contact lenses to include: patient
name; date of service; contact lens
brand, type, quantity and date dispensed; customary costs for services
and materials; amount billed to
the insurance, amount paid by the
patient and method of payment.
RETURN TO BASE
Going back to the question at
hand—whether medical care plans
and vision care plans should make
a greater effort to overlap coverage
for the patient—a related point
is this: even with dual coverage,
many of the medically necessary
treatments fall through the cracks
because vision care plan providers
and medical care plan providers
believe the procedure in question is
not in their sphere of coverage. As
such, both practitioners and their
patients are the ones to take the hit.
However, we may have the ability
to make a difference.
First and foremost, we as practitioners must educate the medical
plan coordinator as to the difference between a vision care expense
and the need for coverage for a
medical condition. If this need is
not successfully communicated, the
patient is left with the confusing
scenario of not understanding why
their medical condition is not covered by the vision care plan. Vision
care plans should strive to provide a
better environment for our patients,
streamline the approval process
and create improved billing efficacy for eye care providers to em-
ploy. Customizing the coverage of
medically necessary contact lenses
may also help insurance companies
develop a competitive advantage for
their products in the marketplace.
Creating clear guidelines may also
help develop a more uniform categorization system for practitioners
to divide patients into, leading to
improved efficiency of submission
for reimbursement and a reduction
in the costs associated with billing
for services.
Many industry watchers believe
that separating the refraction tests
from the medical eye health exam
is coming in the future. The era of
bundling services is a concept of
the past. Each procedure will have
its own billing code with corresponding payment. ICD-10 is the
first attempt to breakout diagnostic
codes, and procedure codes will be
the next project CMS will attempt
to streamline. With the consolidation of medical insurance companies in our immediate future, the
trickle-down effect will soon reach
the vision care plan providers with
medical guidelines filtering into our
vision insurance plans. Educating
administrators with regards to the
complete needs of our patients—
both on the vision care side as well
as the medical care side—will also
allow patients that may not be
aware of current options to receive
the services they require.
H
ealth care insurance is an
ever-evolving entity, and contact lens practitioners must remain
informed of changes that impact the
care we provide. We must remember that some medical conditions
require contact lenses as a serious
form of treatment. For some people, they are not simply a cosmetic
option.
RCCL
1. Aetna. Contact Lenses and Eyeglasses.
Available at: www.aetna.com/cpb/medical/
data/100_199/0126.html. Accessed February 3,
2016.
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5/31/16 4:58 PM
Practice Progress
By Mile Brujic, OD, and Jason Miller, OD, MBA
Brimonidine Breakup
Consider these alternative uses for this common glaucoma treatment.
B
rimonidine is an
interesting molecule
to consider. As an
alpha-2 adrenergic
agonist, many practitioners may most often think
of this medicine for its use in
treating glaucoma. The majority
of brimonidine’s activity resides
in its ability to decrease aqueous
production from the ciliary body,
though it also helps to facilitate
some extra aqueous drainage
through the trabecular meshwork. Currently, brimonidine
is available in three commercial
concentrations: 0.1%, 0.15%
and 0.2%.1
So the question is, why would
we bring this drug up in a
contact lens column? Because
brimonidine has an interesting
side effect profile that may prove
useful to some lens wearers. Due
to its activity on the alpha-2
receptor, it also acts to prevent
pupil dilation under mesopic
and scotopic conditions. This
is done via the inhibition of the
release of norepinephrine from
the pre-synaptic nerve terminal
in the cleft of the dilator muscle,
which allows the tonus of the
sphincter muscle to take over
and ultimately reduces the pupil’s
size (Figure 1).2 Here, we will
discuss three common uses for
brimonidine in the contact lens
wearer.
Orthokeratology. Some patients are able to wear orthokeratology lenses overnight
to facilitate gentle progressive
remodeling of the cornea’s shape
to remove the need for spectacle
or contact lens wear during the
day. The most common type of
refractive error corrected using
orthokeratology lenses is myopia, though advanced designs
now also allow for higher levels
of astigmatism to be corrected as
well via flattening of the central
topography of the cornea to create a midperipheral steep curve.
This results in a corneal appearance topographically similar to
that of a postoperative LASIK
cornea (Figure 2).
But, just as physiological pupil
dilation can affect a postoperative LASIK patient’s vision in
the evening, so too can it affect
a patient who has undergone
Fig. 1. (a) infrared pupil readings prior to the instillation of brimonidine; (b)
five minutes after the instillation of 0.1% brimonidine.
orthokeratology treatment, as
the pupil has the opportunity
to dilate out to the edge of the
treatment zone in certain conditions, potentially affecting vision.
Increasing the size of the treatment zone with modifications to
the lens size or decreasing the
sagittal depth of the lens can
assist with increasing the size
of the treatment zone. In this
case, one alternative is to have
a patient use a drop of brimonidine in mesopic and scotopic
conditions where vision may be
sub-par.
Multifocal Gas Permeable
Lenses. Some of these rigid lenses
may at times have their optical
zones located on their front
surface, while other options will
contain some of the multifocal
optics on both the anterior and
posterior surfaces of the lens.
Multifocal GP lenses are typically designed with the distance
optics located in the middle of
the lens and slowly progressing
to the near optics towards the
midperipheral and peripheral
portions of the lens. Success
with multifocal GPs requires
appropriate centration both
horizontally and vertically. Any
significant displacement from the
location of the pupil in either of
these meridians will affect visual
clarity for the patient.
When appropriately aligned,
multifocal GPs provide excellent
distance vision and the opportunity for translation into the near
optics of the lens. Of course,
there are environments that may
make the vision somewhat more
challenging for these individuals.
40 REVIEW OF CORNEA & CONTACT LENSES | JUNE 2016
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One example is levels of low
light, such as when driving near
sunset. Depending on the amount
of pupil dilation that occurs in
these individuals, their pupils
may widen into the region of the
lens in which the distance optics
begin to transition into the near
optics. Fortunately, most GP lens
designs can be altered to increase
the distance center portion of the
lens to allow for pupil dilation
with less interference of the near
optics.
It is in this case that topical
brimonidine may be beneficial
as an alternative to moving the
zones of the lens to compensate
for mesopic and scotopic conditions. This would provide potential visual benefits to the patient
without the need to change the
properties of the lens itself.
Additionally, since the GP lens
material won’t absorb the medication, the drug can be applied
without removing the lens.
Small Diameter Lenses for
Corneal Ectasia. At times, the
GP lenses that practitioners fit
their irregular corneal patients
with are slightly smaller than
typical to compensate for how
steep the curves on the back of
the lenses are. Interestingly, this
can create challenges for patients
wearing these lenses in the evening, as their pupils may dilate
outside of the optical zones of
the lenses (Figure 3). In these
instances, we can create larger
lenses with aspheric back surfaces to compensate. Additionally,
semiscleral, scleral and hybrid
lenses are often times options
for these individuals as well.
Fig. 2. Orthokeratology lens on the eye (left) and the topography of the
cornea when the lens is removed (right).
However, controlling pupil size
with brimonidine may also be an
option if the patient wishes for
the lens characteristics to remain
the same.
1 gt OU prn for critical viewing
tasks. This statement provides
appropriate guidance to the
pharmacist that the drug is not
to be used on a chronic basis.
PRESCRIBING HABITS
Take note that while the above
information constitutes suggestions for brimonidine use, minimizing pupil dilation with this
drug is not an FDA-approved
indication for the product. As
such, before proceeding with a
prescription for patients in the
instances discussed, we feel it
necessary to mention this fact to
them to ensure they are comfortable using the medication
in such a manner. As with any
off-label indication, the benefits
of treatment must outweigh the
risk of adverse events that may
result from it. Note, brimonidine
use can in some cases lead to dry
mouth or a tired feeling.
We typically prefer to prescribe brimonidine in its lowest
commercially available concentration, which is 0.1% available
as Alphagan P 0.1% (Allergan).
We also send instructions with
the prescription as follows: Sig:
K
eeping this solution in mind
to enhance the vision for
those who may be having some
difficulties will help enhance
their visual outcomes as nothing
else can. So, look into it.
RCCL
1. Allergan. Alphagan P Prescribing Information.
Available at: www.allergan.com/assets/pdf/alphaganp_pi.pdf. Accessed May 8, 2016.
2. Shemesh G, Moisseiev E, Lazar M, Kesler A.
Effect of brimonidine tartrate 0.10% ophthalmic
solution on pupil diameter. J Cataract Refract
Surg. 2011 Mar;37(3):486-9.
Fig. 3. Small diameter lens offcenter in which the lens edge is
approaching the pupil margin nasally.
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Out of the Box
By Gary Gerber, OD
Making the Best of It
Sometimes the situation does not go the best way it can. Here’s how the right attitude
can make the difference for your patients.
T
he airline recently lost
my bag. Nothing is
notable about this fact
in and of itself—actually, it’s happened before.
And indeed, the initial drill this
time was the same as every other
time: wait in a line and fill out
a form describing what the bag
looked like, give the agent your the
baggage stub and pray. Sometimes
you get lucky and they find the bag
with enough time to put it on the
next flight; other times, you may
receive it a few days later having
survived with just your carry-on.
I knew that chances were I’d get it
back eventually, I just didn’t know
when.
This particular time took a different turn, however, once I arrived
at the front of the line to speak to
the agent there. Admittedly, she
had a pretty thankless job since by
definition, everyone she deals with
is unhappy, so I wasn’t expecting
much. Of note, however, was the
way in which she dealt with me
specifically—it made me think
about the way many of us and our
staff members deal with the patients who come into our practices.
Now, there isn’t much she could
have done in terms of recovery
short of snapping her fingers
and producing the lost luggage
then and there. What she did do,
however, was display a funny and
empathetic personality that helped
ease the otherwise negative ordeal.
Thinking about every other
employee I’ve ever encountered or
seen at the airport, she stood out
as different to me in a profoundly
positive way. My impression of her
willingness to help, and the clear
acknowledgment that I was truly
inconvenienced by the lost luggage
was even further helped when she
said, at least what you’re wearing
now will work great for everything
from a corporate business meeting
to a rock concert to a trip to the
beach. But, I understand—you’d
prefer the gold tuxedo in your
suitcase. I’ll try and get it to you as
quickly as I can.
KEEP ONE HAND
ON THE WHEEL
There are many things that occur
in the eye care office that to a
large extent, we cannot control.
Take for example, a patient with
an insurance benefits package that
only covers the cost of a single
examination every two years.
When you recommend to them
that they come in each year, they
may become frustrated. How do
you soothe this situation? The
knee-jerk response for many
practitioners is to simply tell the
patient, we’re sorry, that’s how
your insurance works. It’s not
our fault and send the patient on
their way. However, though this is
factually accurate, it’s not the best
way to deliver this information.
What if the luggage hunter (her
self-given name) I encountered at
the airport said, yeah, I agree—
it’s too bad the airline lost your
luggage. Nothing I can do about
it, though!
Many of us understand the
benefits of turning a bad customer service situation into a good
one by going above and beyond
using a service recovery strategy.
Yet, few people recognize that
even in day-to-day interactions
with patients—whether things go
smoothly from the get-go or not—
an unexpectedly pleasant doctor
and staff demeanor can be just as
memorable. This behavior should
be an integral part of your practice
culture, as there are invariably
many more times that things will
go right instead of wrong as a
result, and many more patients—
essentially all of them—that will
be impacted in a better way. As
an exercise for your staff members, work out some hypothetical
patient encounters that happen
frequently and challenge your staff
to consider the following: how can
a routine, mundane patient-facing
task be changed in such a way
that patients immediately see it as
a positive encounter instead of a
negative or even neutral one? And,
how can our personal execution
and involvement in this task be
modified so patients see us as a
more memorable and positive
advocate for their care?
Though the answer to these
questions likely depends on the
dynamics of the practice and its
staff members, one factor to note:
don’t think in terms of “big heroic
actions” like getting a certain pair
of back-ordered lenses in faster.
Instead, focus on the key “daily
grind” items like booking appointments, escorting patients, completing clinical tests and all of the
other small tasks that, when done
correctly and in a timely manner,
gel together to form your patient’s
good experience with your practice.
RCCL
42 REVIEW OF CORNEA & CONTACT LENSES | JUNE 2016
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