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January/February 2012

Highlights from the 2011 ICL/Toric ICL Experts Symposium
Standard Procedure, Exceptional Results - BY ROBERTO ZALDIVAR, MD

The Next-Generation Visian ICL - BY KIMIYA SHIMIZU, MD, PHD

Clinical Pearls for Implantation of the V4c - BY ERIK L. MERTENS, MD, FEBOPHTH

Evolution of Indications for the Visian ICL - BY ALAA EL-DANASOURY, MD, FRCS

Nighttime Vision With Low-Diopter ICL - BY GREGORY D. PARKHURST, MD

Revolutions in Refractive Surgery - BY GEORGES BAIKOFF, MD

The Visian ICL: A Less-Invasive Refractive Surgery Procedure
- BY JOSÉ F. ALFONSO, MD, PHD
Toric ICL Implantation After CXL to Correct Ametropia in Keratoconic Eyes
- BY MOHAMED SHAFIK, MD, PHD

VISIAN ICL

Standard Procedure,
Exceptional Results
Reviewing 18 years of experience implanting phakic IOLs.
By Roberto Zaldivar, MD

I
t has been more than 18 years since I first implanted a posterior
chamber phakic IOL. My experience back then in the early
1990s has mirrored my current experience, as the majority of
my patients across the decades have experienced excellent visual
results after surgery. But many people are curious about those
visual results—is this excellent visual quality really long term?
In my experience, yes, visual results have been stable over the
years, and this has been true across the numerous phakic IOL
models I have implanted. The key is to conserve the space between
the crystalline lens and the implant. In 1994, I implanted a posterior
chamber phakic IOL in one of my friends. He was hyperopic, and
the lens I implanted was a 10.00 D Visian ICL (STAAR Surgical).
Eighteen years later, my friend’s vision is 20/20 in his right eye and
20/25 in his left. He is still happy with his visual results, and so am I.

BACKGROUND
The first generation of the Visian ICL was introduced in 1993-
1994. This collamer lens was supported by the zonules. At the
time, however, many surgeons were apprehensive of implanting
phakic IOLs because of the associated complications, which

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included decentration, A

excessive vault, pupillary
block, and iris chafing. In my
experience with the original
model, decentration was the
most frequent complication.
This was quickly overcome B
when, based on my suggestions,
STAAR Surgical redesigned
the ICL’s haptics. These new
haptics resembled feet and
were designed to avoid rotation
of the lens. Angulation was
also incorporated into the new Figure 1. (A) The biomicroscopic
design, aiming to improve lens postoperative image demonstrates
positioning within the sulcus. the visibility of the Visian ICL V4c’s
Anterior subcapsular opacities KS-Aquaport, highlighted with the
were also common in the early red arrow. (B) The Sheimpflug image
days of phakic IOLs, largely reveals adequate distancing between
because of inadequate vaulting the V4c ICL and the crystalline lens,
once the lens was implanted. which is called vault.
After this point in time, the main
cause of the induction of anterior subcapsular opacities was surgical
trauma, which is still very rare, as well as high-viscosity ophthalmic
viscosurgical device (OVD) trapped behind the lens or the absence
of vault. Another drawback frequently described was the pupillary

January 2012 I Insert to Cataract & Refractive Surgery Today Europe I 3

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block caused by excessive space
between the implant and the
crystalline lens. Shortly after this
was discovered, we suggested
that peripheral iridectomies
should always be performed
before posterior chamber IOL
implantation. Therefore, the
Figure 2. These optical coherence
use of iridectomies changed the
tomography images show postopera-
dynamics of phakic IOL surgery.
tive ICL vaults of 0.63 mm in the right
Once again, the dynamics
eye and 0.88 mm in the left.
are changing—this time
by eliminating the need for iridectomies by adding a hole
to the Visian ICL. This hole, the KS-Aquaport, allows a more
natural aqueous flow without the need of an additional surgical
procedure. The 0.36-mm aquaport, located centrally, defines the
new design of the V4c ICL (Figure 1). This revolutionary posterior
chamber phakic IOL is actually a revival of the old Centraflow
design, which we developed in 1994.

CASE STUDY
I have implanted the V4c in 12 eyes. Thus far, my most interesting
case is a patient who has the V4c in his left eye and an older Visian
ICL model in the right. Before surgery, UCVA in both eyes was
counting fingers and BCVA was 20/20 with a manifest refraction
of -9.00 -0.50 X 150º and -9.00 -0.50 X 10º in the right and left eyes,


VISIAN ICL

respectively. I implanted a -10.00 D V4c in his left eye and a -12.00 D
ICM125VA in his right. After surgery, his UCVA improved to 20/20
in both eyes, and the modulation transfer function (MTF) and
optical scatter index (OSI) were similar with both lens models (OD
MTF: 36.6, OS MTF: 26.28; OD OSI: 1.1, OS OSI 1.0). The vault was
0.63 mm in the right eye and 0.88 mm in the left (Figure 2).
This patient is a prime example of the effectiveness of phakic IOLs,
and this example especially highlights the usefulness of the Visian
ICL V4c with the KS-Aquaport. With this model, I no longer have to
perform a iridectomy prior to surgery, saving the patient a trip to
the operating room and freeing up more time for my surgical staff.

CONCLUSION
Phakic IOL implantation is a standard surgery for me. I think that
phakic IOL implantation with the Visian ICL V4c will be the future
gold standard of refractive surgery. The most important concept that
our learning curve and experience have provided is the knowledge
that the quality of vision with this lens cannot be compared with the
visual outcomes of any other IOL. The Visian ICL provides the best
point spread function, the best MTF, and the best quality of vision. n

Roberto Zaldivar, MD, is the Scientific Director of the
Instituto Zaldivar, Mendoza, Argentina. Dr. Zaldivar
states that he is a consultant to STAAR Surgical. He may
be reached at tel: +54 261 441 9999; e-mail: zaldivar@
zaldivar.com.


VISIAN ICL

The Next-Generation Visian ICL
Optimizing fluid flow within the eye eliminates the need
to perform peripheral iridotomy.
By Kimiya Shimizu, MD, PhD

M
any studies have shown that visual performance after Visian
ICL (STAAR Surgical) implantation is superior to visual
performance after LASIK.1,2 This was enough to persuade me
to move toward implanting phakic IOLs and away from laser vision
correction in the majority of my refractive surgery patients. Other
surgeons, however, are looking for more advantages before making
the switch. For instance, some feel that the need to perform Nd:YAG
peripheral iridotomy (PI) days before a phakic lens implantation is a
drawback because of the additional surgical visit. Additionally, PIs can
be painful for the patient; they can often lead to significant changes in
the aqueous dynamics after surgery, and they may occasionally cause
cataract, bullous keratopathy, and damage to the corneal endothelium.
With the introduction of a new generation of the Visian ICL, the V4c,
PIs before phakic IOL implantation are a thing of the past. This latest
model may look strange with a hole in the middle, but this hole—the
KS-Aquaport (KS-AP)—eliminates the need for a PI and creates a more
comfortable and convenient experience for both the patient and the
surgeon. By eliminating the need for PI, now phakic IOL implantation
not only offers better visual performance than LASIK, but it also has
equal efficiency.
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COMPUTER SIMULATED
MODELS
The V4c received the
Conformiteé Europeéne (CE) Figure 1. The in- and outflow locations
Mark in April 2011; I helped for the V4c and the conventional ICL.
pioneer the Centraflow
proprietary technology used in this aquaport design. I have been
working with STAAR Surgical since 2004 to investigate aqueous
dynamics after phakic lens implantation in models with and
without a hole located in the center of the lens. First, we simulated
aqueous dynamics after phakic IOL implantation in models with
and without a hole using 3-D eye models. Both ICLs were -9.00 D,
12.0 mm in length, and had a vaulting of 0.50 mm. With both lenses,
the pore space between the posterior iris and the ICL was 0.05 mm
and the angulus iridocornealis was 33º.
Figure 1 shows the in- and outflow locations for aqueous humor
in phakic IOL designs with and without a hole; outflow locations
involved 10% uveoscleral outflow and 90% trabecular outflow. The
solid-state properties of the aqueous humor were equivalent to those
of water, and the degree of viscosity was 7.1917X10-4 Pa·s at a 95º F.
The quantity of aqueous humor produced by the ciliary body was set
at 2.80 µL/min, and the initial pressure was set at 1 atmosphere.
Aqueous humor flowed between the ICL and iris in the
conventional ICL model, but flow was not observed between the
conventional ICL and the crystalline lens. When the hole was present,
however, the flow of aqueous humor was observed between the ICL

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and the crystalline lens.
The diameter of the hole
in these simulations was
at least 0.25 mm.

ANIMAL MODELS
We then conducted
an animal study to
confirm the movement
of aqueous humor
between the ICL and
Figure 2. The movement of aqueous humor the crystalline lens. A
was confirmed in the porcine eye that received phakic ICL with a 0.36-
the ICL with a 0.36-mm hole. mm hole was inserted
into one porcine eye
and a conventional phakic ICL into the other. After surgery, the
flow of aqueous humor was observed by injecting silicone powder
behind the ICL in both eyes; movement was confirmed in the
eye that received the ICL with a 0.36-mm hole. In this eye, the
fluid moved from the lens equator toward the center, most likely
resembling a normal aqueous flow pattern (Figure 2). In the eye
with conventional ICL, we assumed that the aqueous fluid behind
the ICL moved across the lens and toward the location of the PI.
We also examined optical performance by measuring the
modular transfer function (MTF) of both ICL designs. At a spatial
frequency of 100 cycle/mm, the MTF for the conventional ICL and
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the ICL with a 0.36-mm hole A B
was 0.33 and 0.32, respectively.

PILOT, CLINICAL STUDIES
Our next step was to
perform a pilot study.
Implantation of the Visian
V4c was performed in one Figure 3. (A) Cataract formation was
eye of eight patients, with the noted in one eye that received a con-
contralateral eyes receiving ventional ICL; (B) no cataract formation
a conventional ICL. Patients’ was noted in the eyes that received the
average refractive correction V4c with the KS-AP.
was -8.70 D, and the average
cylinder was 2.03 D. We demonstrated that, with the V4c, BCVA
and UCVA were excellent, and there was no rise in intraocular
pressure. Only one cataract was observed, and that was in an eye
with the conventional ICL (Figure 3). Follow-up was 3 years.
We recently conducted a contralateral study in 42 eyes (21 patients) to
compare results with the Visian ICL V4c to results with the conventional
Visian ICL. PIs were first performed in those eyes that did not receive
the V4c. At 1 day postoperative, the anterior chamber was clear and
there were no signs of pigment dispersion or hemorrhage in eyes that
received the V4c. Additionally, there was less inflammation in these
eyes, and visual performance was similar to visual performance with the
conventional ICL. There were no postoperative complications such as
glare and halo, and all patients were satisfied with their results.

VISIAN ICL

CONCLUSION
The Visian V4c is an exciting development. It helps reduce the
burden of phakic lens implantation by eliminating the need for
PI. As we continue our observation of cataract formation after
implantation of the Visian V4c, we are encouraged by the results
from our preclinical and clinical studies and look forward to
implanting more lenses in our patients. ■

Kimiya Shimizu, MD, PhD, is a Professor and Chair of the
Department of Ophthalmology, School of Medicine, Kitasato
University, Kanagawa, Japan.
Dr. Shimizu states that he is a paid consultant to STAAR Surgical. He
may be reached at tel: +81 42 778 8464; fax: +81 42 778 2357; e-mail:
kimiyas@med.kitasato-u.ac.jp.

1. Kamiya K, Shimizu K, Igarashi A, Komatsu M. Comparison of collamer
toric implantable contact lens implantation and wavefront-guided laser in
situ keratomileusis for high myopic astigmatism. J Cataract Refract Surg.
2008;34:1687-1693. Click here for article
2. Igarashi A, Kamiya K, Shimizu K, Komatsu M. Visual performance after
implantable collamer lens implantation and wavefront-guided laser in
situ keratomileusis for high myopia. Am J Ophthalmol. 2009;148:164-170.
Click here for article

VISIAN ICL

Clinical Pearls for
Implantation of the V4c
Inclusion of an aquaport in the center of the ICL boosts
patient—and surgeon—satisfaction.
By Erik L. Mertens, MD, FEBOphth

I
n June 2011, I implanted some of the first phakic IOLs with a 0.36-
mm port located in the center of the optic. This aquaport, which is
designed to restore more natural aqueous flow and eliminate the
need for iridotomy, sets the Visian ICL V4c (STAAR Surgical) apart
from the earlier model, the V4b. Because I no longer have to perform
an iridotomy prior to lens implantation, the V4c has evolved the way I
perform phakic IOL implantation. In this article, I share some pearls for
implantation and highlight a recent case in which I implanted the V4c.
I initially implanted the Visian ICL V4c in five eyes with myopia
(range, -6.00 to -8.00 D) as part of larger series of 100 eyes
implanted with the V4c phakic IOL. These implantations were
prior to the full market launch in countries that accept Conformité
Européenne (CE) Mark approvals. I have now implanted 48 V4c
implants (38 spheric and 10 toric) in approximately 7 months, and
more than 1,300 V4c ICLs have been implanted across Europe.

ADDITIONAL PORTS
In addition to the proprietary KS-Aquaport in the center of the ICL,


VISIAN ICL

the V4c also has two 0.36-mm
ports located just outside the
optic. Designed to simplify
the removal of ophthalmic
viscosurgical device (OVD) after
surgery, these holes also allow
aqueous to flow over a wider
surface are of the crystalline lens.
Inclusion of the aquaport as
well as the two additional ports
Figure 1. OCT image with vault outside the optic of the V4c
measurement and KS-Aquaport give the surgeon a higher safety
visualization. net and, as my patients have
experienced, better surgical
results. Specifically, the aquaport eliminates the need to perform
Nd:YAG iridotomy or peripheral iridectomy before implantation of
the ICL and therefore naturally the possible issues associated with
these procedures. It also potentially reduces endothelial cell loss.

EASY TO PERFORM
The Nd:YAG iridotomy step has been completely eliminated
with the V4c, making the overall procedure more in line with a
LASIK procedure. It is faster, and it is more like a basic consultation
surgery because implantation is done on the same day as the
preoperative examination. During surgery, it is also easier to
remove the OVD.

VISIAN ICL

At the start of surgery, I
load the V4c into an injector
and fill the cartridge with
an OVD. I then use a pair of
forceps to pull the V4c into
the tip of the cartridge until
I can see all three holes. This
will ensure that the lens will Figure 2. Slit-lamp picture; the
be delivered into the anterior KS-Aquaport is visible.
chamber safely and accurately.
Once the lens is in place, I irrigate the OVD from the anterior
chamber, maneuvering the ICL to make some space and directing
my irrigation port toward the aquaport. The OVD easily migrates
from the anterior chamber, where it can then be aspirated safely.

POSTOPERATIVE FOLLOW-UP
One day after surgery, the aquaport is still visible and can be
found slightly temporal to the pupillary center (Figures 1 and 2).
Typically the edges of the lens are not visible, and therefore glare is
minimized. To date, there has been no induction of higher-order
aberrations after V4c implantation. We have not had to change
our nomogram for the ICL.
In my experience, there have been no rises of intraocular
pressure, no change in refractive outcomes, and no patient
complaints or visual symptoms after surgery.


VISIAN ICL

CASE STUDY
In one of my most recent
cases, a patient presented
with thick corneas in both
eyes. He had low myopia,
-0.75 D of sphere in both
eyes. The sulcus-to-sulcus
was 12.20 mm, and the white-to-white was 11.40 mm; I chose a
lens one size larger than the software suggested, implanting a 13.2
VTICM0 instead of a 12.6. Postoperatively, the vault was 760 µm in
the right eye and 620 µm in the left eye.
Just like all of my other patients implanted with the Visian
ICL V4c, this patient was happy with his visual outcomes, and I
was happy that the procedure took less time and was easier to
perform than in the past. The combination of an aquaport in the
center of the optic to alleviate the need for iridotomy and the
additional ports outside the optic to ease removal of the OVD
make the V4c my first choice for patients who are considering a
phakic IOL (Click here to see video). n

Erik L. Mertens, MD, FEBOphth, is Medical Director of
Medipolis, Antwerp, Belgium.
Dr. Mertens states that he is a paid consultant to STAAR
Surgical. Dr. Mertens may be reached at tel: +32 3 828 29
49; email: e.mertens@medipolis.be.

14 I Insert to CataraCt & refraCtIve surgery today europe I January 2012

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Evolution of Indications
for the Visian ICL
Implantation of this lens is not just for patients with high
myopia anymore.
By Alaa El-Danasoury, MD, FRCS

O
ver the past several years, the Visian ICL (STAAR Surgical)
has become my exclusive phakic IOL of choice. Before
this time, I implanted various phakic IOL designs, but,
based on long-term results and patient satisfaction, I reached the
conclusion that the Visian ICL provided my patients with the best
visual outcomes after surgery. I began using the ICL in a select
population of patients with LASIK contraindications—mainly
in those with high myopia, with thin or steep corneas, or with
suspicious topography. Today, however, there are a variety of
indications for phakic IOL implantation that continue to increase
year after year.

ADDITIONAL INDICATIONS
Stable keratoconus. The first indication that I added was
for patients with stable keratoconus. In these cases, I implant
a toric ICL. The caveat is that the keratoconus (refraction and
topography) must be stable for at least 2 years.
In the past 6 years of implanting the Visian ICL in this


VISIAN ICL

population, which includes more than 180 eyes, I have not
had to do a single corneal graft. In a subgroup of 29 eyes with
keratoconus that received the toric ICL to correct compound
myopic astigmatism, all patients are happy with their spectacle-
corrected vision. With the exception of three outliers, all were
within ±0.50 D of intended correction at 12 months. Additionally,
68.9% of eyes gained at least 1 line of visual acuity (1 line, 37.9%;
2 lines, 20.7%; and 4 lines, 10.3%); 31% of patients did not gain
or lose lines, and no patient lost more than 1 line of visual acuity.
I also found that predictability with a toric ICL is similar to
predictability with a standard ICL.
After implantation of an intrastromal corneal ring segment.
I am now also comfortable implanting the Visian ICL in patients
who need further correction after intracorneal ring segment
implantation, as long as keratoconus is stable. These patients are
usually good candidates for ICL implantation as long as they have
acceptable BCVAs.
Corneal collagen crosslinking for keratoconus. Patients
whose keratoconus is stable but still need correction after corneal
collagen crosslinking (CXL) are also very good candidates for the
Visian ICL. CXL has helped thousands of patients with keratoconus
in my practice; however, many of these patients still seek refractive
correction after surgery. Some surgeons are starting to treat, at
least partially, the refractive errors associated with keratoconus
using surface ablation techniques. I do not perform excimer laser
ablation before, after, or simultaneously with CXL, partly because

VISIAN ICL

I am still waiting cautiously
for the long-term results and
predictability. This is also
because I believe that the
Visian ICL is the better choice
to correct refractive error in
these patients, provided their Figure 1. The ICL was implanted in a
BCVA is acceptable. patient who previously underwent
I recently conducted a study corneal grafting. In this case, the vault
to determine the safety and was 0.24 mm.
effectiveness of CXL after Visian
ICL implantation. What I found
is that even if keratoconus
progresses many years after
ICL implantation, it is safe to Figure 2. The ICL can also be implanted
perform CXL with the ICL in in a pseudophakic eye, with adequate
the eye without affecting the space between it and the IOL.
properties of the lens.
After corneal graft. Visian ICL implantation is my procedure
of choice to correct emmetropia after corneal grafts, especially
lamellar grafts. During preoperative counseling, I explain to the
patient that approximately
1 year after corneal grafting the sutures will be removed and then
in an additional 3 months, I will implant a Visian ICL (if the patient
has 1.00 D or less of cylinder) or a toric ICL (if the patient has more
than 1.00 D of cylinder) to correct residual emmetropia (Figure 1).

VISIAN ICL

I choose to implant the Visian ICL instead of performing LASIK
because the predictability is much higher due to variable changes
to the cornea after LASIK.
Pseudophakia. If a patient is pseudophakic and presents with
a refractive surprise, I will now implant an ICL (Figure 2) because
I feel that it provides the best possible results for these patients.
This is the newest indication for me, with only four procedures to
date. These patients are enjoying very good vision after secondary
implantation of the Visian ICL.

INCLUSION CRITERIA
It is easy to see that the phakic IOL is not only for patients
with LASIK indications, and in my practice we use the following
protocol:
• If the patient has very high myopia (more than 8.00 D), the
Visian ICL is the best (only) choice;
• If the patient has high myopia (6.00–8.00 D), the ICL is still my
preferred choice, but I will give the patient the option of phakic
IOL or femtosecond LASIK; and
• If the patient is myopic and has less than 6.00 D, then I will
perform femtosecond LASIK. However, every now and then,
when a patient comes in who knows a family member or friend
with a phakic IOL and wishes to receive the same treatment, I
will happily implant the Visian ICL even in patients with very
low amounts of myopia.
With the Visian ICL’s new improvements, the indications for

VISIAN ICL

phakic IOL implantation and the inclusion criteria will continue
to expand. For instance, I am looking forward to treating patients
with lower refractive errors. I have a lot experience with the Visian
ICL over the past few years, and the bottom line is that sizing is
excellent; the white-to-white measurement is good, the sulcus-to-
sulcus measurement is very good, and there is no iris chafing.

CONCLUSION
Phakic IOLs are an attractive option for refractive correction.
Therefore, the Visian ICL, as well as the toric ICL, are an essential
component of any accomplished refractive surgeon’s practice.
Phakic lens implantation is not a complicated procedure; to me,
this procedure keeps my refractive surgery patients very safe. I do
not have to push the limits of LASIK, and new indications for the
phakic IOL are continually developing, especially after release of
the newest model, the V4c. ■

Alaa El-Danasoury, MD, FRCS, is Chief of Cornea and Refractive
Surgery Service at Magrabi Eye Hospitals and Centers, Saudi Arabia,
Gulf Region & Egypt. Dr. El-Danasoury states that he is a paid
consultant to STAAR Surgical. He may be reached at e-mail: malaa@
magrabi.com.sa.


VISIAN ICL

Nighttime Vision
With Low-Diopter ICL
In one measure of visual quality, the ICL
outperforms LASIK.
By Gregory D. Parkhurst, MD

T
he armed forces are a unique population of individuals who
are exposed to various environments, treacherous war zones,
and frequent trauma. Due to the extreme nature of their
surroundings and the intense demands placed on them, persons in the
military must have excellent vision. The US Army has a conservative
approach to adopting new technology; therefore, before any refractive
surgery technique is approved for use, it must undergo studies to
confirm stability and safety.
Since 2003, more than 160,000 members of the US armed forces have
reportedly undergone successful refractive surgery procedures.1 In 2007,
the US Army began studying the use of phakic IOLs to correct refractive
errors, specifically the Visian ICL (STAAR Surgical). The procedure was
being studied on an investigational basis in soldiers at Army refractive
surgery centers who were not candidates for laser vision correction.
One of the centers that published results of this study was Fort Hood,
Texas, which is home to approximately 42,000 soldiers and is the largest
military installation in the world by land area. Approximately 4,000
refractive surgery procedures are performed each year at Fort Hood.

VISIAN ICL

RETROSPECTIVE ANALYSIS
Several studies have been
performed to test the safety
and efficacy of the Visian
ICL. In the first retrospective
analysis performed at Fort
Figure 1. Refractive predictability
Hood between June 2008 and
plot for 13 eyes that underwent ICL
July 2009, the preoperative
implantation.
characteristics and short-term
postoperative outcomes were analyzed for the first 206 cases of ICL
implantation. Preoperatively, the mean sphere, cylinder, and spherical
equivalent were -5.86 D (range, -2.50 to -11.00 D), -0.68 D (range, 0.00
to -2.25 D), and -6.20 D (range, -2.63 to -11.50 D), respectively, and the
standard deviations were 1.92, 0.51, and 2.04, respectively. A total of 139
eyes were available for 3-month follow-up. At 3 months, 96% of eyes
had achieved a UCVA of 20/20 or better, and 67% of eyes had achieved
a UCVA of at least 20/15. Only six eyes did not achieve at least 20/20
UCVA, all of which had 1.25 D or more of cylinder before surgery.
At 3 months, the average targeted spherical equivalent was -0.22
D; the average achieved spherical equivalent was -0.17 D. Of the 132
available eyes having postoperative manifest refraction, 89% were
within ±0.50 D of intended correction, and 100% were within ±1.00 D
of intended correction (Figure 1).
The safety index for ICL implantation was 1.78, with 34% of patients
gaining at least 1 line of BCVA. Thirteen percent of patients gained 2
lines, 21% gained 1 line, and 65% of patients neither lost nor gained

VISIAN ICL

lines of BCVA. The efficacy index was 1.15, with 79% of patients
achieving the same or better UCVA compared with the preoperative
BCVA. Only 4.8% of patients reported occasional glare and halos,
which was related to the iridotomy in two cases. In one eye, iritis
developed 1 month after surgery. Three ICLs were explanted, one for
excessive vault and two for human error in lens power selection. Lastly,
one patient experienced new-onset nyctalopia. There was no incidence
of postoperative endophthalmitis, retinal detachment, postoperative
cystoid macular edema, pigment dispersion, iris chafing, corneal
decompensation, or cataract.
From this retrospective study, the authors concluded that early results
showed the Visian ICL to be effective in this population when corneal
topography or residual bed thickness was in question for LASIK.
Between June 2008 and December 2010, we implanted the ICL in 792
of the 9,357 refractive surgery cases performed at Fort Hood.

PROSPECTIVE NIGHT VISION ANALYSIS
The second study we performed was a prospective comparative
analysis of 95 eyes that underwent Visian ICL implantation or LASIK.
All eyes were matched by degree of myopia (range, -3.00 to -11.50
D) and had no more than 2.25 D of astigmatism. Visual testing and
aberrometry as well as interpretation of the results were performed
by individuals who were blinded to the procedure. The study was
nonrandomized, as the ICL is still used on an investigational basis
in non-LASIK candidates (ie, patients with thin corneas, abnormal
topography, corneal scars, etc.).

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The LASIK cohort included
A B 24 patients (48 eyes) for whom
a surgeon-specific nomogram
adjustment (DataLink; Surgivision
Consultants) was used to select
Figure 2. Refractive accuracy in the (A) the treatment profile for the
LASIK and (B) ICL groups. laser ablation (400-Hz Allegretto
Wave; Alcon Laboratories, Inc.).
Flap creation was performed using a femtosecond laser (IntraLase;
Abbott Medical Optics Inc.). In all 24 ICL patients (47 eyes), a laser
peripheral iridotomy was performed before lens implantation, and
during surgery a primary incision was placed temporally or on the
steep axis of corneal cylinder. No astigmatic treatments (limbal relaxing
incisions or bioptics) were performed.
Outcome measures included refractive accuracy, photopic visual
acuity and contrast sensitivity, aberrometry, and night vision acuity and
contrast sensitivity. Preoperatively, the mean spherical equivalent before
surgery was -6.04 in the LASIK group and -6.1 in the ICL group (P=NS),
and the mean preoperative astigmatism and pachymetry were 0.96 D
and 0.60 D and 571.3 µm and 547.3 µm, respectively, in each group.
Three months after surgery, almost all (98%) eyes in the ICL group were
within ±0.50 D of intended correction, and 92% in the LASIK group were
within the same intended correction (Figure 2). In reference to distance
UCVA at 3 months, 96% of eyes were 20/20 or better, including cases
with up to 1.50 D of astigmatism and/or abnormal corneas, compared
with 94% of patients in the LASIK group comprised of normal corneas

VISIAN ICL

(Figure 3). Although there
A B
was no significant difference in
photopic visual acuity between
the groups, only eyes in the ICL
group experienced a significant
C
improvement in photopic
contrast sensitivity at 3 months.
Additionally, low luminance visual
acuity improved significantly in
the ICL group, whereas there
was no statistically significant
improvement in the LASIK
Figure 3. Distance UCVA in (A) LASIK
group. Both groups experienced
and (B) ICL patients at 3 months. (C)
a significant improvement in low
Change in BCVA at 3 months.
luminance contrast sensitivity,
and the improvement was statistically significantly greater in the ICL
group (P=.040). This may be due to a greater induction of higher-order
aberrations that was seen after LASIK as compared with ICL implantation.

CONCLUSION
To date, after more than 1,500 cases of ICL implantation at various Army
refractive surgery centers, there have been zero reported cases of retinal
detachment, endophthalmitis, postoperative cystoid macular edema,
or traumatic lens dislocation. Although there is no way to quantify all
types of potential eye trauma, the procedure has seemed to hold up well
to trauma in a few known case reports (Figure 4). In studies performed

VISIAN ICL

A B C

Figure 4. (A) During long-jump training, this patient took a reflector belt to the
eye 10 months after LASIK. (B) Epithelial ingrowth was seen 2 weeks after flap
repositioning in this case, and the patient’s UCVA worsened to 20/50. (C) This patient
was hit with an elbow in the eye 8 months after ICL implantation. The ICL was
rotated vertically, and the patient’s UCVA remained 20/20; no cataract developed.

thus far, the ICL has provided sharp vision and excellent low luminance
contrast sensitivity, two important aspects for soldiers and other patients
who function at night. For these reasons, I consider ICL implantation a
viable option for refractive correction in troops. ■

Gregory D. Parkhurst, MD, is a cataract and refractive
surgeon at McFarland Eye Centers, Little Rock, Arkansas.
Dr. Parkhurst states that he has no financial interest in the
products or companies mentioned. He may be reached at e-mail:
Gregory.Parkhurst@gmail.com.

The views expressed in this article are those of the authors and do
not reflect the official policy or position of the Department of the
Army, Department of Defense, or the US Government. Opinions,
interpretations, conclusions, and recommendations herein are those of
the authors and are not necessarily endorsed by the US Army.

VISIAN ICL

1. Parkhurst GD, Psolka M, Kezirian GM. Phakic intraocular lens
implantation in United States military warfighters: A retrospective analysis
of early clinical outcomes of the Visian ICL. J Refract Surg. 2011.
Click here for article


VISIAN ICL

Revolutions in Refractive Surgery
A review of anterior chamber phakic IOLs.
By Georges Baikoff, MD

W
hen I started
implanting
phakic IOLs
many years ago, there was
no available device to image
the anterior segment. At
the time, the small number
of us surgeons implanting
these lenses were pioneers
of the technology. We did
not know exactly where the Figure 1. There must be adequate
best placement of the lens clearance between the edges of the
was, nor could we predict phakic IOL and the endothelium.
our patients’ postoperative
results. Over time, we learned that in order to have excellent
postoperative results, we needed to respect certain distances in
the anterior chamber, including clearance between the lens and
the endothelium (Figure 1).
Today, we not only have the necessary tools to image the anterior
segment, but we also have state-of-the art phakic lenses that
provide patients with superior visual quality. One of these lenses

VISIAN ICL

is the Visian ICL (STAAR Surgical). The V4b, and now the V4c, has
an expanded treatment range that allows refractive surgeons to
treat all patients—those who are both ineligible and eligible for
LASIK. The newest design is the V4c, which includes Centraflow
technology with the KS-Aquaport. This revolution in phakic IOL
design has simplified the surgical procedure, eliminating the need
for a peripheral iridotomy before implantation.

EARLY PHAKIC IOL DESIGNS
The culmination of the V4c lens design is a product of years of
trial and error with other phakic IOLs. The first attempt at using
an anterior chamber refractive lens to correct high myopia in
the phakic eye occurred in the 1950s. Complications including
glaucoma, corneal dystrophy, and hyphema were associated
with imperfections in the lens design,1 and these efforts were
abandoned. More than 30 years after the initial effort to design a
phakic lens, I, along with Svyatoslav N. Fyodorov, MD, of Moscow,
and Paul U. Fechner, MD, of Germany, tried to develop phakic
IOLs. Dr. Fyodorov’s efforts ultimately led to the development of
several phakic IOL concepts that are still in use today, including
the design of the Visian ICL. The implant that I designed was an
angle-supported implant, the ZB Baikoff Phakic IOL (Domilens
GmbH). This one-piece phakic IOL had a PMMA haptic and
optic. Because of its rigid design, it was inserted through a 5.5-
mm incision. To prevent endothelial loss, at least 1.5 mm was left
in between the edges of the optic and the endothelium. To date,

VISIAN ICL

many of these lenses have been explanted.
The Artisan phakic IOL (Ophtec BV) is another model that had a
rocky beginning. It also has a one-piece lens design with a PMMA
haptic and optic that is implanted through a 5.5-mm incision. One
of the major differences from the ZB Baikoff implant is that it is an
iris-fixated design; this design can cause late considerable endothelial
cell loss, and therefore safety in the earlier models was questionable.
In our study, this lens had a 6% rate of pigment dispersion.
Other phakic lens designs that enjoyed limited successes include
the Vivarte phakic IOL and the Newlife. The Vivarte showed good
safety at 3 years, but after this point endothelial cell loss started to
occur and was higher than the typically acceptable rate of 2%.
The main problem with anterior chamber phakic IOLs was that
they seemed to cause pigment dispersion, which was mainly due
to the forward motion of the crystalline lens. Most of these lens
styles have since been removed from the eyes of our patients, as
pigment dispersion synechiae on the surface of the capsule can
cause cataract.
Today, refractive results after phakic IOL implantation are stable,
thanks to new posterior chamber lens designs, and there are fewer
optical aberrations compared with LASIK.2,3 Phakic lenses surely
have come a long way since the early 1980s, and thankfully we have
a winning formula with the posterior chamber phakic IOL design.

CONCLUSION
To summarize, anterior chamber phakic IOLs cause various

VISIAN ICL

complications that likely warrant removal of the lens. For this
reason, I believe it is important to mainly use a posterior chamber
phakic IOL. ■

Georges Baikoff, MD, is Director and Professor of Eye
Surgery at the Ophthalmology Centre of the Monticelli Clinic,
Marseilles, France. Dr. Baikoff states that he has no financial
interest in the products or companies mentioned. He may be reached
at tel: +33 491 16 22 28; e-mail: g.baik.opht@wanadoo.fr.

1. Baikoff G, Lutun E, Ferraz C, et al. Analysis of the eye’s anterior segment
with an optical coherence tomography: static and dynamic study. J
Cataract Refract Surg. 2004;30:1843-1850. Click here for article
2. Baikoff G, Lutun E, Ferraz C, et al. Refractive Phakic IOLs: contact of
three different models with the crystalline lens, an AC OCT study case
reports. J Cataract Refract Surg. 2004;30:2007-2012. Click here for article
3. Baikoff G, Bourgeon G, Jitsuo Jodai H, et al. Pigment dispersion and
artisan implants. The crystalline lens rise as a safety criterion. J Cataract
Refract Surg. 2005;31:674-680. Click here for article


VISIAN ICL

The Visian ICL: A Less-Invasive
Refractive Surgery Procedure
Implantation of a phakic IOL does not require a flap cut.
By JosÉ F. Alfonso, MD, PhD

T
wo of the largest drawbacks for a young ophthalmologist
just beginning his or her career in refractive surgery are
the surgical complications associated with conventional
microkeratome cuts and the cost of owning a femtoseond laser
to create a LASIK flap. Fortunately, microkertome cuts and
femtosecond-laser assisted flaps are no longer required to provide
patients with the best refractive results, thanks to modern PRK
techniques and new phakic IOLs. These two strategies adequately
correct most ammetropies and provide us with the fundamental
criteria of efficacy, safety, and predictability that our patients need.
In this article, I demonstrate these arguments.
I have more than 25 years of experience performing excimer
laser ablations including PRK as well as LASIK (with and without
a femtosecond laser), phakic IOL implantation, and refractive
lensectomy. Most of our complications after PRK have been
eliminated by intraoperative use of mytomicin C and postoperative
application of sodium hyaluronate and contact lenses for the first
week after surgery. In less than 72 hours after PRK, the wound heals,
and within the first week the patient can resume normal activities.


VISIAN ICL

The range of correction with
PRK is between -5.00 and 2.50
D of sphere, with up to 5.00 D
of astigmatism.

PREFERRED STRATEGY FOR
Figure 1. The spherical diopter range REFRACTIVE CORRECTION
of the Visian ICL spans from -18.00 D My preferred refractive
to 10.00 D. strategy, however, is
implantation of a posterior
chamber phakic IOL, such as
the Visian ICL (STAAR Surgical).
Beyond the good optical
quality, phakic IOLs have a
large dioptric range (Figure
Figure 2. Safety profile of 123 eyes 1), allowing us to correct
implanted with the Visian V4b. practically any refractive error.
Additionally, because this
lens has a large dioptric range (-18.00 to 10.00 D), we can marry lens
implantation with PRK to avoid the need for LASIK.
Numerous studies have demonstrated their good visual results.1-5
In our last study of 123 eyes (71 patients), we implanted the V4b ICL.
The mean preoperative sphere was -8.20 ±3.34 D, which improved to
-0.09 ±0.28 D after surgery. Mean cylinder improved from -0.90 ±0.68
D before surgery to -0.26 ±0.39 after surgery. Distance BCVA improved
as well, from 0.90 ±0.10 before surgery to 1.0 ±0.1 after surgery.

VISIAN ICL

We also showed the safety of
the technique, as all eyes had
the same or better vision after
lens implantation (Figure 2).
The predictability is excellent,
with more than 93% of eyes
reaching the target refraction Figure 3. The mean postoperative
and, because of modern sizing vault in this population of eyes was
nomograms based on optical 464.8 ±228.1 µm.
coherence tomography and
ultrasound biomicroscopy, we
achieved a safe vault in more
than 90% of eyes (Figure 3).
Figure 4. The new Visian V4c has a
Cataract formation was also
hole in the center of the optic.
easily avoided by optimizing
the calculation for selecting ICL size as well as exchanging the ICL if
contact with the crystalline lens occurred. However, several studies
have confirmed that the incidence of cataract after ICL implantation
is approximately 1.3%.2,6-8

A NEW DESIGN, a new STRATEGY
In addition to cataract formation, some surgeons are worried
about inducing a pupillary block after phakic IOL implantation.
Previously, surgeons had to perform an iridectomy before surgery;
however, the newest Visian ICL, the V4c, has a perforating central
hole that allows aqueous humor flow without the need of an

VISIAN ICL

iridectomy. We recently started implanting this lens (Visian V4c;
Figure 4) and are impressed with the normal values of intraocular
pressure measured immediately after surgery. The surgery is easier
and faster than with previous models. Going back to those young
ophtlamologists just starting their refractive surgery careers, even
the novel surgeon can perfect this procedure, as there is only a short
learning curve.
In addition to using the new V4c in my patients, I have also
started to combine ICL implantation with the use of intrastromal
corneal ring segments (ICRSs). This is an effective technique
for patients with keratoconus who also desire a large refractive
correction. With this strategy, the main objective is to correct the
corneal astigmatism with the ICRSs and the sphere with the ICL.
Any residual astigmatism can then be treated with limbal relaxing
incisions performed during the ICL surgery.

CONCLUSION
Phakic IOLs are an excellent choice to correct refractive errors for
various reasons. In addition to the benefits of eliminating the need
for flap creation, whether that is with a conventional microkeratome
or femtosecond laser, phakic IOLs also provide patients with good
optical quality. Specifically, the large dioptric range of the Visian
ICL allows me to correct practically any refractive error, leaving my
patients satisfied. I prefer ICL implantation over all other strategies
and have started combining it with procedures such as PRK and
ICRS implantation for even better results. ■

VISIAN ICL

José F. Alfonso, MD, PhD, practices at the Fernández-Vega
Ophthalmological Institute, Surgery Department, School of
Medicine, University of Oviedo, Spain. Dr. Alfonso states that
he has no financial interest in the products or companies mentioned.
He may be reached at tel: +34 985245533; fax: +34 985233288;
e-mail: j.alfonso@fernandez-vega.com.

1. Alfonso JF, Fernández-Vega L, Lisa C, Fernandes P, Jorge J, Montés Micó
R. Central vault after phakic intraocular lens implantation: Correlation
with anterior chamber depth, white-to-white distance, spherical
equivalent, and patient age. J Cataract Refract Surg. 2012;38:46-53. Click
here for article
2. Alfonso JF, Baamonde B, Fernández-Vega L, Fernandes P, González-
Méijome JM, Montés-Micó R. Posterior chamber collagen copolymer
phakic intraocular lenses to correct myopia: five-year follow-up. J Cataract
3. Alfonso JF, Baamonde B, Madrid-Costa D, Fernandes P, Jorge J, Montés-
Micó R. Collagen copolymer toric posterior chamber phakic intraocular
lenses to correct high myopic astigmatism. J Cataract Refract Surg.
4. Alfonso JF, Fernández-Vega L, Fernandes P, González-Méijome JM,
Montés-Micó R. Collagen copolymer toric posterior chamber phakic
intraocular lens for myopic astigmatism: one-year follow-up. J Cataract
5. Alfonso JF, Lisa C, Abdelhamid A, Fernandes P, Jorge J, Montés-Micó R.
Three-year follow-up of subjective vault following myopic implantable

VISIAN ICL

collamer lens implantation. Graefes Arch Clin Exp Ophthalmol.
2010;248:1827-1835.
6. Sanders DR. Anterior subcapsular opacities and cataracts 5 years after
surgery in the visian implantable collamer lens FDA trial. J Refract Surg.
7. Alfonso JF, Lisa C, Palacios A, Fernandes P, González-Méijome JM, Montés-
Micó R. Objective vs subjective vault measurement after myopic implantable
collamer lens implantation. Am J Ophthalmol. 2009;147:978-983.
8. Fernandes P, González-Méijome JM, Madrid-Costa D, Ferrer-Blasco
T, Jorge J, Montés-Micó R. Implantable collamer posterior chamber
intraocular lenses: a review of potential complications. J Refract Surg.


VISIAN ICL

Toric ICL Implantation After
CXL to Correct Ametropia in
Keratoconic Eyes
Comparison of visual outcomes.
By Mohamed Shafik, MD, PhD

I
n the early stages of keratoconus, corneal integrity can be
restored using several different approaches, including corneal
collagen crosslinking (CXL) to increase corneal rigidity,
intrastromal corneal ring segments (ICRS) to flatten the cornea
and change its refraction, and various forms of keratoplasty to
replace the damaged cornea with a healthy donor. Regardless of
the strategy, the goal of keratoconus treatments is to correct the
patient’s distorted vision and, if caught early enough, spare the
cornea from the need for transplantation.
The newest of these keratoconus treatments is CXL. This
minimally invasive procedure uses riboflavin and ultraviolet light
to increase the crosslinks in corneal collagen, thus flattening the
keratometric values, improving UCVA and BCVA, arresting the
progression of keratoconus, and possibly preventing further
deterioration of vision. The results after CXL are typically
significant in the first 6 months following the procedure and then
stabilize thereafter.


VISIAN ICL

The ultimate goal of CXL is to produce a central shift of the cone,
leading to a stable refraction; however, CXL does not treat the
previous refractive error, and therefore the patient must continue
relying on glasses or contact lenses for correction of sphere and
cylinder. In our high-demand society, patients expect refractive
procedures to offer a solution for all refractive errors. Therefore,
I now offer patients a combination procedure: toric phakic IOL
implantation after CXL. This strategy provides patients with a
practical solution to correct ametropia in a stable, crosslinked
keratoconus eye. I started using this combined procedure in
July 2008, implanting the Visian Toric ICL (STAAR Surgical)
approximately 9 months after CXL to correct the residual spherical
and cylindrical refractive errors.

STUDY
My results with this combination strategy are promising. I
now have 18-month follow-up for 16 eyes, all of which were
keratoconic and had no history or physical signs of ocular disease
(other than myopia); UCVA was 20/40 or worse, and intraocular
pressure was below 20 mm Hg. All eyes had a normal anterior
segment (anterior chamber depth of 3 mm or greater), a clear
cornea 9 months after CXL, and a stable subjective refraction for
at least 3 months before Toric ICL implantation. For each case, the
the lens power was determined based on the patient’s subjective
refraction of sphere, cylinder, and axis. The preoperative mean


VISIAN ICL

BCVA was 0.63 ±0.14. After
surgery, the mean UCVA
was 0.88 ±0.18, with all
eyes gaining 1 or more lines
(Figure 1). I believe these
outcomes were the result of
Figure 1. BCVA (blue) and UCVA (red)
combining CXL with Toric
before CXL; before ICL implantation; 7
ICL implantation, as the CXL
days and 1, 3, and 6 months after ICL
flattened the cornea and
implantation; and 1 and 2 years after
improved corneal symmetry,
ICL implantation.
and the Toric ICL corrected
residual sphere and cylinder
to overcome the aberrations
induced by the previous
corneal irregularity.
Results in these eyes were
Figure 2. Mean keratometry in the ICL compared with the results
(group 1) and ICRS (group 2) groups of 20 keratoconic eyes that
before and at 3, 6, and 12 months after underwent ICRS implantation
surgery. followed by CXL on the
next day. The mean age
in both groups was similar (25.6 ±4.1 years in the ICL group vs
29.7 ±2.6 years in the ICRS group), and there were no intra- or
postoperative complications in either group. At 12 months, the
mean keratometry reading was 48.7 in the ICL group and 49.67 in


VISIAN ICL

the ICRS group (Figure 2).
At 1 week postoperative, the
mean improvement in BCVA
was 0.22 in both groups. By 12
months postoperative, BCVA
gradually increased a total of
Figure 3. BCVA in the ICL (group 1) and 0.29 in the ICL group and 0.42
ICRS (group 2) groups before and at 1 in the ICRS group (Figure 3).
week and 1, 3, 6, and 12 months after Additionally, the spherical
surgery. equivalent in the ICL group
was -0.09, -0.06, -0.05, -0.02,
and -0.02 at 1 week and 1, 3,
6, and 12 months, respectively
in the ICL group compared
with -7.10, -6.32, -7.00, -7.00,
and -6.56 in the ICRS group
(Figure 4).
Figure 4. Spherical equivalent in the
Analyzing these results
ICL (group 1; red) and ICRS (group 2;
revealed that ICRS
yellow ) groups at 1 week and 1, 3, 6,
implantation is a valuable
and 12 months after surgery.
solution for stabilizing
keratoconus, especially in
combination with CXL. However, ICRS implantation with or without
CXL fails to correct the ametropia associated with keratoconus.
We consider Toric ICL implantation after CXL to be a superior
treatment, as it corrects refractive errors after CXL is used to

VISIAN ICL

stabilize keratoconus. Visual acuity after Toric ICL implantation and
CXL is also better than the BCVA after ICRS implantation and CXL.

CONCLUSION
As we know, keratoconus negatively affects not only our patient’s
quality of vision, inducing myopia and astigmatism, but their
quality of life as well. Among available treatment options, I believe
that Toric ICL implantation after CXL is the most promising
modality we have to stop the progression of keratoconus and
correct refractive errors, including sphere and cylinder. CXL alone
only has the power to stabilize the cornea and the refraction, but
without a subjective refraction, it is almost impossible to produce
perfect correction of refractive errors. That is why, together, CXL
and Toric ICL implantation is my procedure of choice in patients
with keratoconus. ■

Mohamed Shafik, MD, PhD, is a Professor of
Ophthalmology, University of Alexandria, and Director of
Horus Vision Correction Center, Egypt. Dr. Shafik states that
he has no financial interest in the products or companies mentioned.
He may be reached at e-mail: m.shafik@link.net.


VISIAN ICL Additional Resources

Visian ICL® brochure
Increase your profitability with
VisianICL®.
Click here to view brochure

Profitability: LASIK
Versus Phakic IOLs PDF
The refractive surgery
profitability model shows that
as phakic IOL volume increases,
so does the profitability margin.
Click here to view pdf

The New Visian ICL® with
CentraFLOW™ Technology
Brochure
Click here to view brochure

42 I INSERT TO CATARACT & REFRACTIVE SURGERY TODAY EUROPE I JANUARY 2012

VISIAN ICL Additional Resources

Visian ICL® Consumer Video
Click here to view video

Visian ICL® V4c Animation Video
Click here to view video

JANUARY 2012 I INSERT TO CATARACT & REFRACTIVE SURGERY TODAY EUROPE I 43

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