PHAKIC FUTURE - LaserMed

CME SERIES
DECEMBER 2007 SUPPLEMENT
D E C E M B E R 2 0 0 7 S U P P L E M E N T
phakic future
IMPLANTABLE COLLAMER LENS
IN RESEARCH & PRACTICE
A VIRTUAL ROUNDTABLE FEATURING FDA
5-YEAR FOLLOW-UP, ICL-LASIK COMPARISONS AND
current CLINICAL APPLICATIONS
Supported by an Educational
Grant from STAAR

OPHTHALMOLOGY WORLD REPORT DECEMBER 2007 SUPPLEMENT
Panelists
Dr. John A. Vukich, MD, is the Medical Director of the Davis Duehr Dean Center
for Refractive Surgery and an Associate Clinical Professor at the University of
Wisconsin-Madison. He is principal investigator for STAAR’s myopic, hyperopic
and toric FDA trials, and medical monitor for all of STAAR’s clinical trials.
He oversees all STAAR training worldwide. With about 15,000 LASIK procedures and
1,000 ICLs to his credit, his practice is about 50% cataract and 50% refractive.
He was the first ophthalmic surgeon in the U.S.A to perform a Visian ICL surgery
after its approval by the FDA. He is member of the American Academy of
Ophthalmology, American Society of Cataract and Refractive Surgery and the
International Society of Refractive Surgery.
The lines between
refractive and cataract
surgery today are blurred
as never before.
Throughout the 1990s, the main focus of cataract surgery
was the safe removal of the cataractous lens with minimal
damage to the eye and preservation or modest improvements
in visual acuity. Intraocular lenses (IOLs) improved steadily in
their refractive outcomes, but few surgeons would have imagined
they could tell patients they’d enjoy spectacle-free acuity.
On the refractive side, the central focus of development was
the refinement of corneal ablation, with ever-more-accurate
excimer lasers enabling surgeons to deliver well-targeted
refractive results while decreasing the main side-effect—induced
higher-order aberrations and the residual visual problems
associated with them.
In the new century, the two trends have converged. While
laser in-situ keratomileusis remains one of the most common
surgeries worldwide, LASIK does not work for every myope
and hyperope wanting to lose their spectacles and in some
countries there is social resistance to corneal ablation. At the
same time, the industry has been developing new lenticular
tools for refractive correction that fit more squarely in the hands
of skilled cataract surgeons than corneal ablation specialists.
These are new generations of multifocal and accommodative
intraocular lenses and their anterior and posterior chamber
cousins, the phakic IOLs. Many patients, whether they entered
for refractive surgery or cataract, are leaving the surgical suite
with excellent and often spectacle-free refractive results. It’s no
longer unusual for cataract surgeons to hear patients say, “And
I won’t have to wear glasses, right?” Excellent post-op refraction
is the expectation, not just the hope.
Twenty months ago, we published an educational supplement
titled “Advances In Intraocular Refractive Surgery” (under the
Ophthalmology Times brand) exploring the evolution, attributes
and early adoption in Asia of one of the most innovative
refractive surgery technologies of recent years—the sulcusfixated
phakic IOL called the Implantable Collamer Lens, or
ICL, made by the US-Swiss company STAAR Surgical. A
growing body of research is showing that the Visian ICL and
its cylinder-correcting cousin, the Toric ICL, are giving cataract
surgeons the means to deliver through a small, cataractstyle
corneal incision the kind of refractive outcomes that rival
or exceed those of the LASIK specialist.
In this World Report Continuing Medical Education Supplement,
we review key clinical studies exploring the safety and
efficacy of this lenticular refractive solution over time and in
comparison the leading corneal ablation strategies, LASIK
and PRK. Foremost is the 5-year follow-up to the U.S. Food
and Drug Administration study that led to the ICL’s approval in
2005, discussed in detail by principal investigator Dr. John A.
Vukich. We also review three studies comparing ICL and Toric
ICL to corneal ablation for treatment of low, medium and high
myopia and myopic astigmatism, as well as Dr. John SM Chang
Jr’s Hong Kong-based studies on the performance of the two
phakic IOLs in Asian eyes. We close with a detailed virtual
roundtable with Dr. Vukich, Dr. Chang and fellow IOL pioneer
Dr. Donald R. Sanders discussing the clinical and practical
implications of refractive correction with a posterior chamber
IOL and how the technology is all but eliminating the distinction
between the cataract and refractive surgery.
Dr. Donald R. Sanders, MD, PhD, an Associate Professor of Ophthalmology at
the University of Illinois at Chicago, works at the Center for Clinical Research in
Elmhurst, Illinois. Since 1982, Dr. Sanders mainly conducts clinical research and is
a recognized expert in the evaluation of ocular inflammation, phakic IOLs, refractive
surgery, IOL power calculation, small incision cataract surgery, and the clinical uses
of corneal topography. Dr. Sanders is consultant for STAAR Surgical and other ophthalmic
companies and has successfully defended pre-market applications before the FDA.
He obtained approval of the first one-piece silicone IOL in the US in 1991,
the first toric-optic IOL for correction of astigmatism in 1998, the first excimer laser
for therapeutic use in 1995 and the approval of the first phakic IOL (Visian ICL) for the
treatment of myopia.
Dr. John SM Chang Jr, MD, is Associate Clinical Professor at the Chinese
University of Hong Kong and Director of the Guy Hugh Chan Refractive Surgery
Centre of Hong Kong Sanatorium & Hospital. With 18,000 LASIK procedures and
nearly 500 ICL implantations under his belt, his main area of interest is cataract
and refractive surgery. He is clinical instructor for many refractive intraocular lenses and
surgeries such as LASIK surgery, intra-corneal ring, conductive keratoplasty and phakic
intraocular lenses (Visian ICL and Toric ICL). He is a member of the International Refractive
Surgery Society and has been recognized by the American Acadamy of Ophthalmology and the
A.C.E. program of the Asian Pacific Association of Cataract and Refractive Surgery for
his significant contributions to training of surgeons in the Asia-Pacific region.
Asia HQ 1305 Nansuzhou Road, 1F Shanghai 200003 Phone: +86 21 6359 3631 • Fax: +86 21 6359 3630
India: Phone: +91 11 4166 8408 • Fax: + 91 22 6645 9002
Global editorial board Chief Medical Editor, India Edition Dr. P. Namperumalsamy, MD Chief Medical Editor, China Edition Dr. Zhang Kang, MD, PhD Executive Editors Dr. Rajvardhan Azad, MD • Dr.
Robert Gale Martin, MD • Dr. He Wei, MD Senior Advisory Board Dr. Ge Jian, MD • Dr. Lingam Gopal, MD • Dr. Kulin Kothari, MD • Dr. Li Xiaoxin, MD • Dr. Gullapalli N. Rao, MD • Dr. Xie Lixin, MD
Consulting Editor Shashi Kapoor, MD Global Column Editors Cataract Dr. Debasish Bhattacharya, MS • Dr. Mahipal Sachdev, MD • Dr. Ye Zilong, MD Retina Dr. Manish Nagpal, MS • Dr. Biju Raju, MS • Dr.
Tang Shibo, MD Refractive Dr. Lu Wenxiu, MD • Dr. D. Ramamurthy, MD Cornea Dr. Rajesh Fogla, DNB, FRCS • Dr. Liu Zuguo, MD Dr. Sheng Minjie, MD Glaucoma Dr. Tanuj Dada,MD • Dr. He Mingguang,
MD Occuloplasty/ Ophthalmic Education Dr. A.K. Grover, MD Uvea Dr. Vishali Gupta, MD • Dr. Yang Peizeng, MD Orbit/Oncology Dr. Santosh Honavar, MD Medical Ophthalmology Dr. Mallika Goyal, MS
Neuro Ophthalmology Dr. Satya Karna, DO, DNB Contributing Editors Dr. Au Eong Kah-Guan, MD • Dr. David F. Chang, MD • Dr. Debraj Shome, DO, DNB • Dr. Gaurav Shah, MD • Dr. Geoffrey Tabin, MD •
Dr. Sanghamitra Burman, MD • Dr. Parijat Chandra, MD • Dr. J.E. McDonald, MD • Dr. John S.M. Chang, MD • Dr. Luther Fry, MD • Dr. R. Ramakrishnan, MD • Dr. Y. Ralph Chu, MD • Dr. Rohit Saxena, MD •
Dr. Rishi Swarup, MD • Dr. Savari Desai, MD • Dr. Suhas Haldipurkar, MD • Dr. Seenu Hariprasad, MD • Dr. Uday Devgan, MD • Dr. Usha Raman, PhD • Dr. Zhang Zhenping, MD Editorial Editorial Director
Jeffrey K. Parker Managing Editor, India Edition Mridula Chettri Singh International Editor Larry Schuster News and Supplements Editor Stephanie Schweimnitz Assistant Managing Editor, China Edition
Anny Xiao Editors Dr. Hao Xiaojun • Chelsea Zhao Publishing &Advertising Group Publisher Grant J. Prigge gjprigge@ilxmedia.com +86 21 6359 3631 X 888 Business Development Director Jaideep Bajaj
jaideep@ilxmedia.com +91 98101 83544 Account Managers Henry Zhu hzu@ilxmedia.com Art Direction, India Seoyoung Kang. skang@ilxmedia.com Circulation Associate Eunice Zhang

OPHTHALMOLOGY WORLD REPORT DECEMBER 2007 SUPPLEMENT
FDA STUDY COHORT AT 5 YEARS
FOLLOW-UP RESEARCH CONFIRMS
icl is SAFE, STABLE ALTERNATIVE TO LASIK
Figure 3 Figure 4
By Larry Schuster
Reviewed by Dr. John A. Vukich, MD
Follow-up monitoring of patients who participated in the
FDA study that led to approval of the Implantable Collamer
Lens demonstrates a highly stable refraction and very low
incidence of complications. With the completion of five
years of montoring, the investigators are reporting results
consistent with most intraocular procedures.
The researchers have now followed some patients for more
than seven years, with similar results.
“Anecdotally, it continues to look very consistent with what
we’ve seen over the first 5 years—that these are tolerated
well, longitudinally they continue to do very well,” said
Prinicipal investigator Dr. John A. Vukich, associate clinical
professor at the University of Wisconsin at Madison and
medical director of the Davis Duehr Dean Center for Refractive
Surgery.
“This will give surgeons the confidence that these are
reasonable things that produce a huge quality of life
improvement for my patients and appear to be safe over
the long run.”
Of 576 patients in the FDA study, at five years, 1.3% developed
cataract. And all of those who developed cataract had
at least 12.75D pre-op myopia. Cataract Incidence was 10
times greater for patients who were at least 40 Years old (3%
Vs. 0.3%). (See Figure 1).
Figure 1
Researchers also reported a highly stable outcome, with a
mean spherical equivalent at five years of -0.49D.
(See Figure 2).
The results from the follow-up study, Dr. Vukich said, reinforced
the findings of other trials showing that the ICL is a
safe, stable alternative to LASIK, and it’s often a better one.
Dr. Vukich is principal investigator for STAAR’s myopic,
hyperopic and toric FDA trials, and medical monitor for all
of STAAR’s clinical trials. He oversees all STAAR training
worldwide. With about 15,000 LASIK procedures and 1,000
ICLs to his credit, his practice is about 50% cataract and
50% refractive.
In one earlier study comparing the implantable collamer
lens and LASIK for the treatment of low myopia (Cornea
2006;25:1139–1146), researchers found the ICL safer and
more effective than LASIK.
STAAR consultants Donald R. Sanders, MD, Ph.D., and
Dr. Vukich, MD said, “In this comparison of concurrently
performed cases with 3 to 7.88 D of myopia, the ICL safety
and effectiveness outcomes were superior to all FDA target
values and were comparable to or better than our LASIK series
in all key parameters and previously approved excimer
LASIK study results.”
In this study, Dr. Sanders of the Center for Clinical Research,
Elmhurst, Illinois, USA, and Dr. Vukich, said the
Figure 2
study involved 1,678 LASIK eyes and 144 ICL eyes from the
14-site US Food and Drug Administration Trial for Myopia.
In the ICL series, 86% of eyes had a BSCVA of 20/20 at
baseline, remaining at 86% at 1 week and then improving to
96% at 1 month and 98% at the 6-month visit.
In the LASIK group, 92% of eyes had 20/20 or better
BSCVA at baseline, dropping to 83% at 1 week, and increasing
to 89% at 1 month and 91% at 6 months after surgery.
(See Figure 3).
During the 6-month course of the study, 2 ICLs were replaced
within the first postoperative week because the ICLs
were too large. One ICL was repositioned twice because of
improper placement of the ICL. No ICL removals occurred
during the course of the study. No cataract extractions were
performed on any patient during the course of the study.
No ICL cases were treated with LASIK or had an ICL replacement
for improper refractive correction.
The results from the follow-up study,
Dr. Vukich said, reinforced the findings of
other trials showing that the ICL is a safe,
stable alternative to LASIK, and it’s often
a better one.
cally higher in the ICL group at all postoperative periods.
(See Figure 4).
All of the reported ICL outcomes from the US ICL study
and LASIK outcomes from this series were better than the
no more than 7D safety and efficacy FDA target values for
preoperative myopia (MRSE).
The authors noted, the improvement in predictability of the
ICL at 6 months over the LASIK procedure was “especially
dramatic in view of the fact that 25% of the LASIK cases required
enhancement surgery compared with none of the ICL
cases, and astigmatism was treated routinely in the LASIK
cases, whereas only spherical correction was attempted with
the ICL.” (See Figure 5).
This study follows the authors’ 2003 report (Cornea 22(4):
324–331, 2003) that compared ICL and LASIK clinical
outcomes in the treatment of moderate to high myopia. The
earlier study had a similar result, they reported.
In this highly myopic series, UCVA 20/20 or better was 50%
with ICL compared with 35% with LASIK (p < 0.001). No
serious complications occurred in either series of cases.
Figure 5
Retreatments with the laser (enhancements) occurred in 416
LASIK eyes (25%). Diffuse lamellar keratitis was diagnosed
and treated in 81 eyes (4.8%). Striae were noted in
the corneal flap in 30 eyes (1.8%), and in 24 of these eyes
(1.4%), the flap was lifted to smooth out the striae. One free
cap (0.06%) was noted in the series with no loss of BSCVA.
Preoperatively, 99% to 100% of eyes in both groups had
UCVA worse than 20/200. Uncorrected acuity improved
dramatically in both groups.
The proportion of cases seeing 20/15 or better was numeri-

OPHTHALMOLOGY WORLD REPORT DECEMBER 2007 SUPPLEMENT
Late-breaking randomized trial
Further support for
Toric ICL over corneal ablation
By Larry Schuster
Reviewed by Dr. Donald R. Sanders, MD, PhD
In a prospective, randomized study comparing the Visian
Toric Implantable Collamer Lens (Toric ICL) and photorefractive
keratectomy (PRK) in the correction of moderate to high
myopic astigmatism, researchers found the Toric ICL performed
better than the PRK in all key measures.
The superior outcomes of the Toric ICL were evident in
uncorrected visual acuity, refractive predictability, refractive
stability, change in best spectacle-corrected visual acuity,
change in contrast acuity, and glare symptoms. In addition,
dry eye complaints were lower with the Toric ICL procedure.
First author Steven Schallhorn, MD, Department of Ophthalmology,
Navy Medical Center San Diego, San Diego, Calif.,
and colleagues said the study provided further evidence that
the Toric ICL is a viable alternative to existing refractive
surgical treatments.
Figure 1
Figure 2
“A number of other clinical trials have compared outcomes
between the Visian ICL and LASIK or PRK, the researchers
wrote in their paper, published in the Nov. 23 issue of the
Journal of Refractive Surgery (J Refract Surg. 2007;23:853-
867). “All showed superior results of the ICL for various
refractive ranges. The outcomes of this comparison of PRK
and the Toric ICL support these findings and demonstrate that
in this study, Toric ICL correction results in a more effective
procedure than PRK surgery.”
They further note, “The dramatic improvement in outcome of
the ICL over LASIK or PRK is not unexpected as it is more
accurate to manufacture the exact correction required in a
HEMA material than to ablate the correction onto corneal
tissue, which is then subject to tissue healing.”
Completed at the Naval Medical Center San Diego, USA, the
study compared the clinical outcomes of PRK to the unapproved
toric phakic IOL for the correction of moderate to high
myopic astigmatism.
It involved 43 eyes implanted with the Toric ICL (20 bilateral
cases) and 45 eyes receiving PRK with mitomycin C (22
bilateral cases) with moderate to high myopia ( 6.00 to 20.00
diopters [D] sphere) measured at the spectacle plane and 1.00
to 4.00 D of astigmatism. Patients were followed for 1 year.
Patients had to be between the ages of 21 and 45 years, have a
stable refraction for the last 12 months as documented by previous
clinical records, and have a manifest refraction spherical
equivalent (MRSE) progression at a rate of 0.50D or less
during the year prior to the baseline examination.
Patients with a history of previous intraocular surgery, diabetes,
glaucoma, ocular hypertension, amblyopia, and/or any
serious ophthalmic or non-ophthalmic conditions that may
have precluded study completion were excluded.
Figure 3
in the PRK series in the early healing period (1 week; 19%
vs 0%, P=.006). Improvement in BSCVA (2 or more lines)
was statistically better in the Toric ICL group at 1-month
follow-up (0% vs 10%, P=.010), and the entire distribution of
change in BSCVA was statistically better with the Toric ICL
at all visits through 12 months (P .001).
The outcomes of this comparison of PRK
and the Toric ICL ... demonstrate that in this
study, Toric ICL correction results in a more
effective procedure than PRK surgery.
Improvement of 1 or more lines of BSCVA was better with
the Toric ICL series at all time periods studied (P .001).
Ninety-five percent of patients had an improvement of 1 or
more lines of BSCVA in the Toric ICL series at 12-month
follow-up compared to 39% in the PRK series.
(See Figure 2).
The proportion of cases with BSCVA of 20/12.5 or better
was significantly higher in the Toric ICL group at all postoperative
time periods (12 months; 71% vs 14%, P .001). Additionally,
the proportion of cases with BSCVA 20/16 or better
Figure 4 Figure 5
was also significantly higher in the Toric ICL group at all
postoperative periods. When using the entire distribution of
BSCVA values and not just the breakdown of 20/12.5, 20/16,
or 20/20, the Toric ICL had significantly better BSCVA at all
postoperative visits between 1 week and 12 months (P .001).
On adverse events, at 2 years postoperatively, the presence
of a grade 2 anterior subcapsular cataract was noted in one
(2.3%) Toric ICL patient. The patient had a preoperative
refraction of 6.50 2.25 @ 170°. One month postoperatively,
BSCVA was 20/25 (same as preoperatively) with a refraction
of 0.25 0.50 @ 019° and a clear crystalline lens.
The patient subsequently was lost to follow-up until 2 years
later. Best corrected vision at that time was 20/50.
On effectiveness outcomes, uncorrected visual acuity
improved dramatically in both groups. The proportion of
cases seeing 20/12.5 or better and 20/16 or better was significantly
higher in the Toric ICL group at all postoperative
time periods. Using the entire distribution of UCVA values
and not just 20/12.5, 20/16, or 20/20 cutoffs, the Toric ICL
was significantly better than PRK at all follow-up examinations
(P .001).
The Toric ICL showed a much larger percentage of eyes in
which the postoperative UCVA was better than the preoperative
BSCVA (61% vs 18%). Looking at the entire distribution
of the relationship between preoperative BSCVA to
the 12-month UCVA outcomes for the Toric ICL and PRK
procedures, the Toric ICL was statistically better (P .001).
(See Figure 3).
Predictability (attempted vs achieved correction) favored the
Toric ICL numerically at all postoperative visits ( 0.50D and
1.00D) and was statistically better at all time points except
12 months with regard to 0.50D (76% vs 57%, P=.101). The
scattergrams at 12 months postoperatively demonstrate more
variability in the PRK group and a tendency to overcorrect.
(See Figures 4 and 5).
RESULTS
On best spectacle-corrected visual acuity, the mean change
was significantly better with the Toric ICL than with PRK at
all time periods from 1 week through 12-month follow-up. At
all time periods, the Toric ICL group demonstrated significantly
more improvement in BSCVA than the PRK group
(P .001). (See Figure 1).
Loss of 2 or more lines of BSCVA was significantly higher

OPHTHALMOLOGY WORLD REPORT DECEMBER 2007 SUPPLEMENT
Impressed by performance
Advantages of modified
Visian ICL & Toric ICL
in Chinese eyes with high myopia
Figure 3
virtual roundtable
World Report conducted extensive interviews with
Dr. Vukich, Dr. Chang and Dr. Sanders to attain a deeper
understanding of the research and its implications for the
cataract and refractive practitioner in India or China who
already is implanting the Visian Toric ICL and Visian ICL,
or is considering doing so. We have edited their responses
into this “virtual roundtable”, grouping them into a range of
topics for ease of presentation.
By Stephanie Schweimnitz
Reviewed by Dr. John SM Chang Jr, MD
Following a successful FDA clinical trial of the Visian phakic
intraocular lens for the correction of moderate to high myopia
in Caucasian eyes, researchers in Hong Kong are reporting
similar results in two trials of Chinese eyes.
The two studies, conducted by John SM Chang Jr, MD, Director
of Guy Hugh Chan Refractive Surgery Centre of Hong
Kong Sanatorium and Hospital, and his colleagues achieved
positive results. To achieve those results, researchers modified
the calculation of the Visian PIOL lens size (STAAR ICL
and STAAR Toric ICL) for implantation in Chinese eyes that
suffered high myopia.
The first longterm trial of the modified Visian Implantable
Collamer Lens (Visian ICL V4) in Chinese eyes, published
in the Journal of Refractive Surgery, included 40 patients (J
Refract Surg. 2007;23: 17-25). They had a mean preoperative
manifest spherical refraction of -14.54D, mean cylinder of
1.83D, mean age of 34.9 years and mean follow up of 13.67
months. On visual acuity, all eyes achieved a postoperative
UCVA of >/= 20/40 and 75% of the eyes had a postoperative
UCVA >/= 20/20. (See Figure 1). A manifest spherical
equivalent refraction of +/- 1.0D was predictable in 97% of
the eyes and a manifest spherical equivalent refraction of +/-
0.5D was predictable in 88% of the eyes.
The longterm stability and refractive outcomes of the second,
unpublished study with Toric ICL, were also very encouraging.
It involved 34 patients
with a mean age of 31.8
years, a mean preoperative
manifest spherical
refraction of -14.65D and
a mean follow up of 18.5
months. After 12 months,
a MRSE within +/- 0.5D
was achieved by 94% of
the eyes and a MRSE within +/- 1.0D was achieved by 100%
of the eyes. Furthermore, 59% of the eyes had a cylinder
within +/-0.5D and 94 % had a cylinder within +/- 1.0D. (See
Figure 2). The results remained stable for the two-year follow-up
period. (See Figures 3 and 4).
In an interview with Ophthalmology World Report, Dr.
Chang said, “These results are better than my LASIK results
for sure, particularly when you are talking about these high
levels of myopia. The vision results are really very, very
impressive.”
Chinese eyes have statistically significant smaller white-towhite
measurements, shallower anterior chamber depths,
thicker central corneas and a higher prevalence for high myopia
and astigmatism than Caucasian eyes. (See Figure 5).
Despite the fact that the surgery can be a mental issue as
surgeons have to be very careful in order to avoid hitting the
lens and hitting the endothelium, the learning curve, especially
for cataract surgeons, is very short. A typical surgery
needs less than 10 minutes.
Figure 4
acuity. Using the Toric ICL, the achieved results were encouraging
and the rate of complications was very low.
“I’ve done a few patients who were around -12D, and done
one eye with LASIK and one with ICL. They all regret doing
LASIK. Definitely the ICL gives a better quality of vision,”
Dr. Chang said.
Figure 5
SAFETY & STABILITY
World Report The thrust of the 5-year data is clinically significant
cataracts and anterior subcapsular lens opacities. The
concern is the induced cataract of earlier-generation phakic
IOLs, right?
Dr. Vukich Those are things that people are right to be
interested in, but we also look at visual acuities, long term
drift or lack of drift in terms of attempted vs. achieved. Essentially
the 5-year data show there was virtually no change
in quality of vision or drift of refractive error over time. The
main interest in any phakic IOL is not so much the optical
quality, since most people now accept at face value that we
can fundamentally correct a refractive error with an IOL.
The concern has always been: What is the safety? What is
the long-term risk of a lens over time? Could this cause other
problems inside the eye as an additive technology instead of
removing and replacing the natural lens? Is this additional
lens going to crowd the segment? Is it going to cause glaucoma
or cataract formation or corneal decompensation? We
focus primarily on cataract formation because that was one
of the initial concerns. We have gotten better at understanding
what shapes, sizes and types of configurations are best
tolerated and most efficacious. This is the fourth generation
ICL. In earlier versions we had cataract rates that were as
high as 12-15%, which clearly is an unacceptable level and
not one we would tolerate.
World Report The key design change was increasing the
vault, right?
Figure 1
“It’s more of a mental thing than anything else. Once you get
over the mental block, and just get in there and be careful,
it’s really much easier than you’d expect, “ Dr. Chang said.
Visian ICL and Toric ICL for high myopia eyes help prevent
night vision problems, overcorrection and gradual regression
of myopia, all of which have been side effects of LASIK.
Visual acuity, accuracy and predictability are better than
with LASIK. With LASIK, only about 84% would have
been within the target of -1D. Both Toric ICL and ICL can
be applied for a wider range of myopia than LASIK (-3.0D
to -20.0D), can correct hyperopia (+ 3.0D to +17.0D), are
reversible, accurate, stable and show a high rate of visual
Dr. Vukich That’s correct. We increased the vault, or the
clearance of the lens over the crystalline lens. It was a very
simple change in terms of the geometry, but critical in terms
of how it is tolerated. We know that when you use this lens
there will be some patients who develop cataract. There’s no
avoiding that. The data show it’s going to be in that 1% or
1.5% range, typically in the first couple of years. The concern
is whether that’s going to be a progressive issue where more
and more patients continue to show this until it becomes
a bigger problem. We are officially at 5 years, though we
are now compiling 6- and 7-year data, and it continues to
look very consistent with what we’ve seen over the first 5
years—that these are tolerated well. This will give surgeons

10 OPHTHALMOLOGY WORLD REPORT DECEMBER 2007 SUPPLEMENT
11
the confidence that these are reasonable things that produce a
huge quality of life improvement for patients and appear to be
safe over the long run.
World Report All of the cataracts have been in patients above
-12.75D. Does this suggest that the thicker lens needed for the
higher correction is more likely to be problematic?
Dr. Vukich I don’t know if we can make a cause-and-effect
relationship. Another hypothesis could easily be: Are patients
with higher levels of myopia more prone to developing
cataract? We know in the US population epidemiologically
the rate of nucleus growth and cataract formation is higher in
patients above -12D.
World Report What happens as these ICL patients enter
cataract age?
has closed the gap, but it still isn’t as good.
World Report Can you give us some background to the
study comparing the Toric ICL to PRK?
Dr. Sanders This was the Schallhorn Navy study in San
Diego. They randomly assigned astigmatic patients to receive
either the Toric ICL or PRK. They did PRK because at the
time they thought the incidence of complications with PRK
would be less, using PRK with mitomycin to avoid corneal
haze. They believed this was the best procedure for our
active military people. But once the results started to come
in, they actually considered stopping the study because the
results were so dramatically skewed in favor of the ICL. All
the measures of contrast were dramatically better for the
ICL, best corrected acuity was better, uncorrected acuity was
better, predictability was better.
Dr. Vukich If there’s cataract, you remove the ICL and do
cataract surgery. Think of it this way: Every ICL you put in
will come out at some point in a patient’s life. If they live
long enough they will get normal age-related cataract. The
lens comes out as easily as it goes in. It does not fibrose into
the sulcus. It does not become lodged or difficult to remove.
It does come out through a 3mm incision or less. They don’t
have to be disassembled or cut to be removed, but simply
grasped and pulled. They fold upon themselves and come out.
Removing the lens is not a clinical challenge and it’s consistent
with small-incision cataract technique.
World Report Is the causal factor known for this small number
of cataracts? Is it something about the lens itself, or the
implantation, or both?
Dr. Vukich We don’t really know. We can credibly hypothesize
that any intraocular surgery will cause a level of cataract
formation. We know this from filtration surgery for glaucoma;
there’s a cataract rate in that. There’s a cataract rate following
vitrectomy. Basically any intraocular surgery in which you
change the fluid balance and osmotic loading on the crystalline
lens. If you make an incision in the eye and place visco
in, and take visco out, and then close the incision, without
putting anything in—basically a sham operation—you are
probably still going to get a cataract rate of 1% or so. Any of a
number things could provide the insult to the crystalline lens.
World Report Looking at the follow-up data, can you conclude
that if cataract is going to be induced that you’ll see it in
the initial years after implantation?
Dr. Vukich That’s a fair statement. All of the evidence supports
that. If for whatever reason, surgical trauma or whatever,
you’ll see the problems in the first couple of years. The
majority of the changes that we’ve observed were present
in the first six months. Our conclusion is that there does not
appear to be a time-based risk that is increasing with time of
service. So the longer the lens is in the eye does not appear
to cumulatively increase the risk of complications. It’s welltolerated
over time, and there’s no obvious inflection point
where long-term complications become apparent.
World Report Dr. Sanders, comparing the risks of corneal
infections vs intraocular infections, what does the 5-year and
comparative data show about ICL safety?
Dr. Sanders Infection with the ICL is very low. We know
of only one or two. When you consider the number of ICL
we’ve put in, the number is very small. If you look at visual
loss, I believe the excimer laser has more potential for visual
loss than the ICL. Obviously infection is a risk because you
are going inside the eye. But with LASIK you get things like
diffuse lamellar keratitis (DLK) and visual loss related to the
excimer procedure. You get DLK certainly within the first 6
months. In intraocular surgery, endophthalmitis is immediate.
You know right away. But because the crystalline lens is
in place and acts as a barrier, if you get an infection it usually
does not spread right away to the vitreous. If you see something
and treat it aggressively, there’s a good possibility you
are not going to have serious issues.
TORIC ICL AND ICL VS LASIK
World Report Dr. Sanders, the earlier studies compared the
sphere-correcting Visian ICL with LASIK, and the results are
clearly compelling. But as custom ablation has improved, how
does the ICL and particularly the Toric ICL stack up against
advanced corneal ablation?
Dr. Sanders The earlier studies were all comparisons with the
spherical ICL against the laser procedures of that time, when,
for instance, there was not yet custom ablation. In all of the
studies, the ICL performed better than LASIK for virtually
every visual and refractive parameter---best corrected acuity,
uncorrected acuity, proportional cases within +/- 1D and
+/- 0.5D of correction. It was more predictable and appeared
to be safer. We started by looking at the higher myope, at -8D
to -12D of myopia, and the advantage was clear; they weren’t
even close. In every case ICL had a visual improvement and
the laser procedures had a visual loss, because we know that
excimer lasers induce higher-order aberrations. There is no
question that the excimer laser degrades the optical system
somewhat. With the ICL and Toric ICL there is virtually
no corneal healing. You put it in into a small clear corneal
incision that doesn’t induce astigmatism and doesn’t change
overall refraction. We concluded that the ICL should be
considered within the whole range of what the correction is
allowed, from -3D all the way to -20D.
World Report So the Visian ICL is a viable alternative across
the board, but what about the Toric ICL?
Dr. Sanders As we published the data, people said, “That was
then. But now we are using custom ablation.” So we took the
Toric ICL FDA clinical trial data and compared it to the data
that was used in the US FDA custom ablation clinical trials.
We compared similar data for myopic astigmatism from the
Toric ICL study with the lasers. Again, we found no variable
where the Toric ICL was worse, but found a significant numbers
of variables where it performed better. Custom ablation
ICL IN ASIAN EYES
World Report Dr. Chang, why did you turn your research
focus to Asian eyes?
Dr. Chang Sizing is quite important for the ICL. There had
been some papers available for Caucasian eyes, but not
much on Asian eyes. There are slight differences, but Asian
anterior chambers are really no deeper than Caucasian eyes,
ranging from 2.8mm to 3.57mm with a mean of 3.13mm.
We have a high incidence of myopia in Asia and if you look
at the study you can see that the average sphere is -14.65D,
compared to about -8D in the Caucasian studies. Our average
cylinder is 2.89D. Along with the high myopia we often
have this higher astigmatism. These were all Chinese eyes,
Han eyes. And, yes, the anatomy of the eye is different. The
mean white-to-white ratio for Chinese eyes is only 11.4mm,
whereas for the mean Caucasian eye it’s over 12mm. We have
smaller white-to-white.
World Report Were there any surprises in your Asian eye
studies?
Dr. Chang I was very impressed with the performance of the
Toric ICL. Obviously there’s great stability. If you look at
the stability even up to 24 months, there’s hardly any myopic
shift. When we do LASIK, we generally have to overcorrect
by 1D or 1.5D, and it takes them up to six months to
stabilize. And often they progress. But with the standard ICL
and the Toric ICL they do not. They stay very stable, both in
terms of cylinder and spherical aberration. Look at the vision
results: I had 94% within half a diopter of target refraction
and 59% within half a diopter of cylinder, and 100% within
plus or minus 1 diopter of sphere and 94% within plus or
minus 1 diopter of astigmatism. These results are better than
my LASIK results for sure, particularly when you are talking
about these high levels of myopia. We didn’t test for contrast
sensitivity and didn’t formally survey about halo and glare,

12 OPHTHALMOLOGY WORLD REPORT DECEMBER 2007 SUPPLEMENT
13
but very few of our patients complained about that. I would
say less than 10%.
SELECTING BETWEEN LASIK & ICL
World Report Is there anything in the five-year results that
would compare safety levels for LASIK vs. ICL for correction
of low levels of myopia, that is, below -8D?
Dr. Vukich LASIK is safe. It’s one of the most commonly used
surgical procedures in the world and there’s not a great deal
of concern about the safety of LASIK in the lower levels of
correction. We believe the ICL remains fundamentally very
safe as well. However, when we have potential contraindications
to LASIK—significant dry eye, corneal topography
that is atypical or unusual or of concern, keratoconus or thin
corneas—anything that would give rise to thoughts about the
stability of the cornea for any procedure that’s corneal based,
that is exactly where a non-corneal-based refractive procedure
becomes a fantastic choice. When we look at corrections at
-8D and above, the ICL is a very legitimate contender. In the
lower powers, I think it’s a legitimate contender where there’s
a need to keep doctors and patients out of trouble. If there is
something about an evaluation of a patient that makes you
think twice about is this a good LASIK candidate, that’s the
patient you shouldn’t treat with LASIK.
World Report Dr. Chang, what is your protocol for selecting
ICL over LASIK?
Dr. Chang Basically patients with corneas that are too
thin—somebody who is a high myope, over -10D, with a
cornea of, say, less than 480 microns, I’d be very reluctant to
do LASIK. In fact I wouldn’t do it. I’d say do the ICL or just
forget it. That’s with thin corneas. Otherwise, everything else
being equal, -12D is my cutoff. ICL has changed this. My
cutoff used to be -14D.
World Report that’s actually quite significant, since -8D
tends to be the threshold for LASIK vs ICL.
Dr. Chang In the West, the threshold for ICL generally is
-8D, while in Asia, at least in Hong Kong, Singapore and
other major cities, our threshold is probably about -12D. The
difference is that in Asia, most city dwellers don’t drive very
much. People stay to the city and don’t do a lot of country
driving or freeway driving. It’s mostly well-lit streets. So
halo and glare and even diminishing contrast sensitivity is
not so much of a problem compared to say someone who
lived in Australia or the US or even in parts of mainland
China or India. I think most surgeons in Asian cities would
take LASIK up to -12D. Some might go even higher.
World Report So now add the ICL to the equation in this
threshold zone.
Dr. Chang In a few patients who were around -12D, I’ve done
one eye with LASIK and one with ICL. They all regret doing
LASIK. Definitely the ICL gives a better quality of vision.
World Report What was the rationale for doing the eyes differently?
Dr. Chang LASIK is relatively well-known and considered
safe. So some patients are afraid to take a chance with both
eyes. They feel they’ll take the safe route with one eye and
take a chance with the ICL with the other. I have another patient
who is -13D in one eye and -19 in the other. She had ICL
in the -19D eye and LASIK in the -13D and she still prefers
the -19D eye. ICL definitely gives better quality of vision
when you are talking about, say, -10D and above.
World Report With the Toric ICL, can you target cylinder
correction as accurately as spherical?
Dr. Chang It’s not as impressive as sphere, but almost. With
spherical equivalent, I’m at 100% within 1D, while with
cylinder I’m only 94% within 1D, and only 59% within half a
diopter. So cylinder correction is not quite as targetable, but
still impressive when compared to LASIK. In LASIK, for
the higher myopes, there’s a relationship between sphere and
cylinder. When you are doing a lot of cylinder, it can affect
the sphere results. With LASIK, the accuracy does drop for
higher myopes and you have to consider regression over time.
BIOPTICS
World Report The highest myopic correction with ICL is
-19D, but surgeons do go higher with bioptics—using ICL
for the main correction and corneal ablation for the residual.
This is common up to -25D and higher. But is there a point
where the patient might be better served with a clear lens
extraction—replacing the natural lens rather than complementing
it?
Dr. Vukich There are many clinics that do bioptics; it’s quite
common. Most surgeons, and especially Asian surgeons who
deal with this population frequently, completely understand
the risks of retinal detachment when you start getting into the
very high myopic patients. The instability of the vitreous following
a refractive lens exchange can lead to a relatively high
rate of retinal detachment. We see a 2-6% retinal detachment
rate at 2 years, which is a huge problem for the patient. I
think that’s why we are seeing surgeons using bioptics. ICL
is not approved as a bioptic implant. But we know from experience
that it seems to be very efficacious in that application.
World Report Dr. Chang, are you combining ICL and LASIK
correction in your practice?
Dr. Chang Yes, for the non-toric I’ve gone very high, up to
-27D. I put in the -19 ICL and did the residual with LASIK.
That patient is very good. Some surgeons don’t like to use
ICL above -15D. They believe this lens is thicker so they
think there’s a higher chance of cataract. If the eye is shallow,
I’m more concerned. I may not push it to -19D. If the
anterior chamber is fairly deep, say 3mm or above, I’m quite
comfortable using the thicker lens.
AGING & PRESBYOPIA
World Report Dr. Vukich, in the FDA cohort, how are ICL
patients coping with presbyopia?
Dr. Vukich They are using reading glasses just like the rest of
the world. People who are emmetropic at age 45 and above
will use reading glasses. The ICL doesn’t make presbyopia
any more or less likely. It doesn’t seem to change the fundamental
dynamics of how the human lens matures over time.
World Report Dr. Chang, where do you stand on accommodation?
Dr. Chang If I have any patients over 40, I would do monovision.
The dominant eye I would fully correct and the nondominant
eye I would actually undercorrect, leaving some
myopia. If they were just 40 and showing no presbyopia yet,
I would leave just one diopter. If they were 44 and already
have some presbyopia I would leave more. My target would
be 1.5D of residual myopia. With monovision, if one eye is
plano and the other eye is -1D, they can get to 50 and not
need any spectacle correction at all. It works very well. I’ve
done monovision using LASIK on over 3,000 patients. We’ve
done some mini-surveys that we’ve not published, and 80%
of those patients do not wear any correction at all.
World Report How do your patients respond to that slight
residual myopia, with ICL or LASIK?
Dr. Chang Out of the 3,000 I have about 10 patients who
could not tolerate that. That’s for LASIK. With ICL we’re
much more careful. If I were doing monovision with ICL I
would ask the patient to go and fit a contact lens in the non-

14 OPHTHALMOLOGY WORLD REPORT DECEMBER 2007 SUPPLEMENT
15
dominant eye at the target refraction, with residual myopia,
and have them wear it for a while. We can always do LASIK
on the eye if we leave residual and they don’t like it, but that
is an extra cost. If I were doing this with a LASIK patient,
I’d be a little more lenient. But with ICL patients I insist
that they first try out the monovision target refraction with a
contact lens.
OPTIMAL PATIENT
World Report What’s your optimal patient for the ICL?
Dr. Chang The studies are now showing that the younger
patients are less likely to develop cataract. The youngest
patient I’ve done was 20, and I’m quite comfortable doing
younger patients. When I first started I focused more on
older patients, the almost 40s. The concern is that in very
young patients the eye is still growing longer, so we want to
see stable refraction for at least one year. If it’s a patient I’ve
been following for some time, I won’t insist on one year.
I’ll accept 6 months. But if it looks like they’ve progressed,
I’ll definitely wait another six months.
LEARNING CURVE
World Report Dr. Vukich, how important is skill to the ICL’s
safety and stable performance?
Dr. Vukich There’s no question that skill plays a role. You
want to practice state-of-the-art ophthalmology, but this really
isn’t just for the extremely gifted and talented surgeon.
Any surgeon who is comfortable in the anterior segment is
absolutely capable of doing a very fine job with this lens.
World Report Dr. Chang, how would you describe the ICL
learning curve?
Dr. Chang I think it’s more of a mental issue than surgical.
We’re all cataract surgeons. We are all used to working in
narrow spaces. But to have that dilated pupil, and the endothelium
right there. I always say it’s like working between the
devil and the deep blue sea. You go one direction and hit the
endothelium; you go the other and you hit the lens. It can be
scary. But having said that, it’s really not that difficult. Once
you get over the mental block, and just get in there and be
careful, it’s really much easier than you’d expect. My average
case now is maybe 7-10 minutes.
BRIDGING CATARACT
& REFRACTIVE
World Report What are the implications of the comparison
studies for our 17,000 readers in China and 10,000 in
India—countries with 1 billion-plus people and huge gaps
between rich and poor?
Dr. Sanders Not everyone can afford an excimer laser. The
cost of the ICL is that the doctor has to learn how to put it
in, but it’s not a volume issue. In the developing world if you
want to buy an ex-cimer laser you have to know you can do
600-800 cases a year to amortize the cost. With the ICL fixed
costs are minimal. Another problem is service. In China or
India if you are away from a big city, getting your laser serviced
may be a problem. The ICL is a lens. You put it in and
you’re done. It’s not capital intensive.
World Report Isn’t this technology putting a much higher
level of refractive accuracy in the hands of cataract surgeons,
enabling them to start acting more like refractive surgeons?
Dr. Vukich That is a global trend. Cataract surgery is refractive
surgery, and it always has been. Our patients not only
want improved vision, they want freedom from glasses as an
expected result of cataract surgery! Given the opportunity to
lose their glasses, people will come to expect that as a result
of cataract surgery. The universal goal will be not just to
remove the cataract but to leave the patient spectacle free.
World Report In China there’s still a cataract/refractive firewall.
Refractive surgeons can do LASIK all day long, but few
do intraocular surgery. How should they view the ICL?
Dr. Chang Refractive surgeons should not completely separate
themselves from cataract surgery. You don’t have to be
a volume cataract surgeon to be an ICL surgeon. If you do
one or two cataracts a week it’s enough, though if you are a
high-volume cataract surgeon, it’s easy. This firewall has to
come down. We now also have multifocal IOLs. People in
the presbyopic age who are myopic will probably do better
with a refractive lens exchange than with LASIK. Nowadays,
I’ve begun moving about 10% of my LASIK patients over to
the lens exchange group. I just did a patient who was -31D
of myopia, functionally blind. I put in a multifocal and the
patient came back 20/25 uncorrected. I’ve moved a lot of my
bioptics patients over to clear lens extraction. This firewall
has to come down because the lines are really blurring between
cataract and refractive.
World Report Dr. Vukich, where do you see the balance?
Dr. Vukich Let’s say, for sake of argument, that the risk is 5%
in someone who is -20D. You can turn that around and say
that 95% of the time you are going to have a patient who is
absolutely thrilled with an excellent quality of vision. One
out of 20 times there is a possibility that they may require a
lens extraction that still will leave them emmetropic; cataract
surgery is well within the skill set of these surgeons who are
capable of using these implants. So rather than do a refractive
lens exchange or clear lens extraction in the first place,
you’ve got a 95% chance of having an out-standing quality
of vision. And if it turns out that there something more than
needs to be done, the solution is readily available and executable
by the same surgeon and it will lead to the patient being
where they wanted to be anyway—with good emmetropic
vision—by doing cataract surgery with an implant. We don’t
want that to be the case in a high percentage of patients, but
the fact is, if it’s a problem that can be readily addressed and
fixed, it’s not as big a problem as if you have corneal instability
or ectasia or intractable night glare or other problems
that you’d get with high myopic LASIK treatment. Yes, it’s a
problem but it’s a problem that can be fixed.
World Report What’s your advice for the refractive surgeon
who doesn’t do much cataract?
Dr. Vukich This is a challenge. Keeping your intraocular skill
set current requires that you work inside of the eye at some
frequency. Anyone who is trained to work inside the eye
can quickly reestablish that comfort level. But if you haven’t
worked inside the eye for several years, having concentrated
primarily on LASIK, it’s going to feel awkward going back
in. Probably the biggest challenge for the LASIK-only surgeon
is that they may not have a readily available intraocular
surgery suite. We do these lenses in the same setting as
cataract surgery—a clean, sterile environment for intraocular
procedures. One of the beauties of the ICL is that if you do
cataract surgery, you already have an operating room ready,
you have a routine where you are in the eye anyway. The ICL
can just flow right in.
POSITIONING IN PRACTICE
World Report Dr. Sanders, what do you see as the practical
implications of these studies?
Dr. Sanders The people who have been doing these studies,
whether it’s Dr. Vukich and Dr. Schallhorn, do
a lot of LASIK. They have no particular reason
to want the ICL to look better, given that their
practice is mostly LASIK, not ICL. We are not
saying that the ICL should replace LASIK. But
we are saying it should be an active consideration
in every patient who falls within the range of its
approval status. Phakic IOLs in general are an
excellent option because you don’t have to worry
about healing as a part of the equation. You can
get more accuracy and more predictability. It’s a
faster procedure. In LASIK, wound healing gets
in the way.
World Report Some US surgeons are saying
you need to cannibalize your LASIK practice to
build your ICL practice. Dr. Chang, are you in
that camp?
Dr. Chang Financially, LASIK is better for
me than ICL. I do ICL as a service. It’s a great
lens and works very well, but if you are talking
about cost-wise, both for the patient and the surgeon, at least
in my practice, LASIK is more cost-effective. Putting cost
aside, with the ICL you don’t have to worry about regression.
The quality of vision is better. If the patient is not concerned
about cost, ICL is the way to go. For India and China the
cost factor will be the major issue. Ironically, as you get out
into the countryside, the need for the ICL is probably greater
because of the issues of glare and halo, but the affordability
becomes a major issue. It definitely makes sense to add ICL
if you have a patient base that can afford it.
World Report Do you market the lens?
Dr. Chang Hong Kong is quite conservative and we are not
allowed to market, but I’ve been using the ICL for about five
years and I’m starting to get good word of mouth business.
This year I expect my ICL volume will have doubled. It’s
a simple fact that more patients have done it and they refer
their friends. It’s definitely a workhorse lens in my practice.
World Report Dr. Vukich, are you in the cannibalization
camp, promoting ICL over LASIK?
Dr. Vukich The right word is not cannibalize, but supplement.
They are synergistic and grow one another, and you develop
a reputation of providing excellent quality of care. Patients
don’t want LASIK and they don’t want an ICL. They want to
see better. Once you change your focus to say, OK, we are going
to provide you with the best quality of vision and here are
the different options and tools we have to achieve that goal,
we are going to customize our selection based on what your
needs are, that really grows the practice. People come to know
that you are not just a LASIK surgeon. In fact, my LASIK
practice has grown as we have continued to offer the ICL.

16 OPHTHALMOLOGY WORLD REPORT
Supported by an Educational Grant from STAAR
Published By ILX MEDIA GROUP
Chairman James F. Marshall • Chief Executive Officer Grant J. Prigge • Chief Operating Officer Jeffrey K. Parker
Ophthalmology World Report is a monthly English-language publication published for the owners of ILX Media Group at New Delhi, India. Available on a controlled / free for distribution basis
to qualified practicing ophthalmologists in India. S-65, 2nd Floor, Greater Kailash, Part II, New Delhi-110048.
Copyright 2007 ILX Media Group. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photography,
recording or information storage and retrieval system, without permission in writing from the publisher. Authorization to photocopy items for internal or personal use of specific clients,
can be granted by ILX Media Group for libraries and other users registered with the publishers.