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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

Standard Procedure, Exceptional ResultsStandard Procedure, Exceptional Results

The Next-Generation Visian ICL - The Next-Generation Visian ICL -

Clinical Pearls for Implantation of the V4c - Clinical Pearls for Implantation of the V4c -

Evolution of Indications for the Visian ICL - Evolution of Indications for the Visian ICL -

Nighttime Vision With Low-Diopter ICL - Nighttime Vision With Low-Diopter ICL -

Revolutions in Refractive Surgery - Revolutions in Refractive Surgery -

The Visian ICL: A Less-Invasive Refractive Surgery Procedure The Visian ICL: A Less-Invasive Refractive Surgery Procedure

Toric ICL Implantation After CXL to Correct Ametropia in Keratoconic EyesToric ICL Implantation After CXL to Correct Ametropia in Keratoconic Eyes

January/February 2012

Staar_VisionICL_DigiSupp.indd 1 3/8/12 11:19 AM

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

VISIAN ICL


VISIAN ICL

It 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.

BACKGROUNDThe 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

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


January 2012 I Insert to CataraCt & refraCtIve surgery today europe I 3

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included decentration, excessive vault, pupillary block, and iris chafing. In my experience with the original model, decentration was the most frequent complication. This was quickly overcome 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 design, aiming to improve lens positioning within the sulcus.

Anterior subcapsular opacities were also common in the early days of phakic IOLs, largely because of inadequate vaulting once the lens was implanted. 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

Figure 1. (A) The biomicroscopic

postoperative image demonstrates

the visibility of the Visian ICL V4c’s

KS-Aquaport, highlighted with the

red arrow. (B) The Sheimpflug image

reveals adequate distancing between

the V4c ICL and the crystalline lens,

which is called vault.

A

B



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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 use of iridectomies changed the dynamics of phakic IOL surgery.

Once again, the dynamics 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 STUDYI 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,


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Figure 2. These optical coherence

tomography images show postopera-

tive ICL vaults of 0.63 mm in the right

eye and 0.88 mm in the left.



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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.

CONCLUSIONPhakic 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: [email protected].


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Insert to CataraCt & refraCtIve surgery today europe I January 2012

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Many 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.

The Next-Generation Visian ICLOptimizing fluid flow within the eye eliminates the need to perform peripheral iridotomy. By KIMIyA SHIMIZU, MD, PHD



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COMPUTER SIMULATED MODELS

The V4c received the Conformiteé Europeéne (CE) Mark in April 2011; I helped 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

Figure 1. The in- and outflow locations

for the V4c and the conventional ICL.



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

ANIMAL MODELSWe then conducted

an animal study to confirm the movement of aqueous humor between the ICL and the crystalline lens. A phakic ICL with a 0.36-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

Figure 2. The movement of aqueous humor

was confirmed in the porcine eye that received

the ICL with a 0.36-mm hole.


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the ICL with a 0.36-mm hole was 0.33 and 0.32, respectively.

PILOT, CLINICAL STUDIESOur next step was to

perform a pilot study. Implantation of the Visian V4c was performed in one eye of eight patients, with the contralateral eyes receiving a conventional ICL. Patients’ average refractive correction 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.

Figure 3. (A) Cataract formation was

noted in one eye that received a con-

ventional ICL; (B) no cataract formation

was noted in the eyes that received the

V4c with the KS-AP.

A B



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CONCLUSIONThe 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. n

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: [email protected].

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


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

Clinical Pearls for Implantation of the V4cInclusion of an aquaport in the center of the ICL boosts patient—and surgeon—satisfaction.By ERIK L. MERTENS, MD, FEBOPHTH



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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 outside the optic of the V4c give the surgeon a higher safety 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 PERFORMThe 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.

Figure 1. OCT image with vault

measurement and KS-Aquaport

visualization.



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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 be delivered into the anterior 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-UPOne 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.

Figure 2. Slit-lamp picture; the

KS-Aquaport is visible.



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CASE STUDYIn 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: [email protected].


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VISIAN ICL

Over 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 INDICATIONSStable 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

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



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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



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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 BCVA is acceptable.

I recently conducted a study to determine the safety and 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 perform CXL with the ICL in the eye without affecting the 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).

Figure 1. The ICL was implanted in a

patient who previously underwent

corneal grafting. In this case, the vault

was 0.24 mm.

Figure 2. The ICL can also be implanted

in a pseudophakic eye, with adequate

space between it and the IOL.



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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 CRITERIAIt 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.

CONCLUSIONPhakic 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. n

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: [email protected].



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The 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.

Nighttime Vision With Low-Diopter ICLIn one measure of visual quality, the ICL outperforms LASIK.By GREGORy D. PARKHURST, MD



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RETROSPECTIVE ANALYSISSeveral studies have been

performed to test the safety and efficacy of the Visian ICL. In the first retrospective analysis performed at Fort Hood between June 2008 and July 2009, the preoperative 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

Figure 1. Refractive predictability

plot for 13 eyes that underwent ICL

implantation.



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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 ANALYSISThe 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 24 patients (48 eyes) for whom a surgeon-specific nomogram adjustment (DataLink; Surgivision Consultants) was used to select the treatment profile for the 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

Figure 2. Refractive accuracy in the (A)

LASIK and (B) ICL groups.

A B



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(Figure 3). Although there was no significant difference in photopic visual acuity between the groups, only eyes in the ICL group experienced a significant 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 group. Both groups experienced a significant improvement in low 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.

CONCLUSIONTo 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

Figure 3. Distance UCVA in (A) LASIK

and (B) ICL patients at 3 months. (C)

Change in BCVA at 3 months.

A

C

B



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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. n

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: [email protected].

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.

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.

A B C



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


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VISIAN ICL

When 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 best placement of the lens was, nor could we predict 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

Revolutions in Refractive SurgeryA review of anterior chamber phakic IOLs. By GEORGES BAIKOFF, MD

Figure 1. There must be adequate

clearance between the edges of the

phakic IOL and the endothelium.



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 DESIGNSThe 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.

CONCLUSIONTo 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. n

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: [email protected].

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


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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

Two 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 REFRACTIVE CORRECTION

My preferred refractive 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 1), allowing us to correct 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.

Figure 1. The spherical diopter range

of the Visian ICL spans from -18.00 D

to 10.00 D.

Figure 2. Safety profile of 123 eyes

implanted with the Visian V4b.



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 and, because of modern sizing nomograms based on optical coherence tomography and ultrasound biomicroscopy, we achieved a safe vault in more than 90% of eyes (Figure 3). Cataract formation was also 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 STRATEGYIn 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

Figure 3. The mean postoperative

vault in this population of eyes was

464.8 ±228.1 µm.

Figure 4. The new Visian V4c has a

hole in the center of the optic.



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.

CONCLUSIONPhakic 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. n



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: [email protected].

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


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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.



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VISIAN ICL

Toric ICL Implantation After CXL to Correct Ametropia in Keratoconic EyesComparison of visual outcomes.By MOHAMED SHAFIK, MD, PHD

In 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.

STUDYMy 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 combining CXL with Toric ICL implantation, as the CXL flattened the cornea and improved corneal symmetry, and the Toric ICL corrected residual sphere and cylinder to overcome the aberrations induced by the previous corneal irregularity.

Results in these eyes were compared with the results of 20 keratoconic eyes that underwent ICRS implantation 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

Figure 1. BCVA (blue) and UCVA (red)

before CXL; before ICL implantation; 7

days and 1, 3, and 6 months after ICL

implantation; and 1 and 2 years after

ICL implantation.

Figure 2. Mean keratometry in the ICL

(group 1) and ICRS (group 2) groups

before and at 3, 6, and 12 months after

surgery.



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 0.29 in the ICL group and 0.42 in the ICRS group (Figure 3). Additionally, the spherical 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).

Analyzing these results revealed that ICRS implantation is a valuable 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

Figure 3. BCVA in the ICL (group 1) and

ICRS (group 2) groups before and at 1

week and 1, 3, 6, and 12 months after

surgery.

Figure 4. Spherical equivalent in the

ICL (group 1; red) and ICRS (group 2;

yellow ) groups at 1 week and 1, 3, 6,

and 12 months after surgery.



VISIAN ICL

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

CONCLUSIONAs 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. n

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: [email protected].


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

VISIAN ICL Additional Resources

Visian ICL® brochureIncrease your profitability with

VisianICL®.

Click here to view brochure

Profitability: LASIKVersus Phakic IOLs PDFThe 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 BrochureClick here to view brochure

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

VISIAN ICL Additional Resources

Visian ICL® Consumer VideoClick here to view video

Visian ICL® Consumer Video

Visian ICL® V4c Animation VideoClick here to view video

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