Pursuing a New Vision
IOL innovations to expect in the next year and beyond.
BY CHRISTOPHER KENT, SENIOR ASSOCIATE EDITOR
INTRODUCTION BY MARK PACKER, M.D.

Cataract patients today have a whole new world of choices and options to consider. Far from not having an implant, our patients learn about accommodative technology and improved functional vision via the Internet. One patient recently walked into our offices asking if we were investigators "for either the Tecnis multifocal or the dual optic accommodative lens." Current patients may engage us in a discussion about blue light toxicity or the effect of multifocality on contrast sensitivity. With today's patients so well-informed, it's essential for us to understand the options we have at our disposal, and to be able put them to work for the greatest benefit of our patients.

The article on the following pages lists new products you can look forward to in the next 12 months. But first, I'd like to talk about some of the issues behind these new products, and mention some of what lies ahead beyond the next year.

We're experiencing an incredible flowering of new technology for pseudophakia. Like us, investors see a flood of baby boomers needing cataract surgery or wanting refractive lens surgery within a few years. Venture capital drives technology forward, and early interest in the crystalens accommodating IOL (eyeonics, Aliso Viejo, Calif.) has served to increase opportunities for a spectrum of new technologies.

Restoration of accommodation. In a recent survey of ASCRS members, 100% of respondents expressed interest in accommodative lenses (Leaming DV. Practice styles and preferences of ASCRS members -- 2003 survey. J Cataract Refract Surg 2004; 30: 892-900). Second-generation lenses, including the dual optic designs of the Synchrony IOL (Visiogen, Irvine, Calif.) and the Sarfarazi Elliptical IOL (Bausch & Lomb, St. Louis, Mo.) are getting close to initiation of U.S. clinical trials. Third-generation accommodative lenses are also on the horizon; these will feature innovative designs and large amplitudes of accommodation. The SmartLens (Medennium, Irvine, Calif.) may function to restore accommodation as well, and is progressing towards off-shore clinical trials. In addition, injectable polymers are under de- velopment by several companies.

Enhancing vision quality. Updated FDA labeling for the Tecnis IOL (Pfizer, New York, N.Y., in the process of being acquired by Advanced Medical Optics, Santa Ana, Calif.) states that it improves highway safety by improving functional vision. The complementary prolate design of this lens reduces spherical aberration based on a population average cornea model. (For more Tecnis news, see page 39.)

Customization. The innovative Light Adjustable Lens from Calhoun Vision (Pasadena, Calif.) remains an exciting prospect as well because it offers the potential for true customization of an IOL after implantation. Once the IOL is stable in the eye, it's irradiated with ultraviolet light, which creates fine adjustments in the lens to achieve perfect correction of defocus, astigmatism and higher-order aberrations. The correction in the lens can be readjusted until the desired goal is achieved, and then locked in. Information from off-shore trials has been reported by Daniel Schwartz, M.D., and we eagerly await initiation of clinical trials in the United States.

Bimanual microincision phaco. This type of surgery has created exceptional interest over the past year. Bimanual phaco courses and talks have remained well-attended, and Jorge Alio's new book, Microincision Cataract Surgery (Highlights of Ophthalmology, 2004) was a best-seller at the recent ASCRS Symposium in San Diego. However, it's unlikely that this type of surgery will become widely adopted until IOLs that can be implanted through incisions smaller than 1.5 mm become available. The first prospect in the United States is the Thinlens from ThinOptX (Abingdon, Va.), a diffractive implant only 100 microns thick with a range of correction from -25D to +25D. Results from Europe are promising, particularly in terms of improved quality of vision, but concerns remain about long-term stability with capsular fibrosis. (For more Thinlens news, see "Also Happening This Year" on page 40.)

Prevention of capsular fibrosis. This remains a topic of interest for cataract surgeons, but the interplay between IOL edge design and dysphotopsia has created an issue for manufacturers. Surgeons would much rather perform a YAG capsulotomy than deal with ongoing patient complaints of peripheral scotoma or edge glare. The degree of dysphotopsia depends not only on edge design, but also on the properties of the IOL material, including the refractive index and reflectivity. One new IOL in clinical trials that may have found a way to resolve this problem is the C-Flex from Rayner (Hove, East Sussex, UK). (For more on this, see "Also Happening This Year" on page 40.)

Economic Impact

All this new technology will almost certainly cause significant changes in pricing and earnings. Already, eyeonics has shaken up "business as usual" by developing a premium product at a premium price. Manufacturers won't be likely to forego profits if the market will bear these rates. These changes will set the stage for surgeons to re-examine the value of their work and develop pricing accordingly.

Needless to say, all of this expansion will take place completely outside of Medicare unless regulations are revised to allow balance billing of patients for premium intraocular implants. We're currently able to offer the crystalens to cataract patients with private insurance by developing an agreement with the payer and the patient to bill the patient for the extra cost of the lens, but there remains no mechanism to do this within the Medicare system. While ostensibly trying to avoid the creation of a double standard, Medicare is now looking at a significant impediment for its beneficiaries. This situation can't last forever.

Ready to Ride the Wave

As Howard Fine, M.D., is fond of saying, "The story of IOLs is still unfolding." And while the next 12 months won't bring us all of the innovations described above , there can be no doubt that within a few years technology will change the landscape of cataract and refractive lens surgery.

In the meantime, get ready for innovation and growth in your cataract and refractive lens surgery practice, starting with the products described in the following pages. Offering the latest technology in IOLs will undoubtedly give surgeons a marketing edge, helping them ride the demographic tidal wave that's headed our way.

Alcon's AcrySof ReSTOR IOL combines apodized diffractive and refractive optics to create a range of vision.

ALCON

Alcon expects to launch two products within the next 12 months: the AcrySof ReSTOR "pseudoaccommodative" lens, and the AcrySof Toric IOL.

The AcrySof ReSTOR IOL. The AcrySof ReSTOR IOL is now in the final phases of FDA trials. Unlike accommodative lenses, it doesn't depend on contraction of the ciliary muscle to move the lens to create a range of vision. Instead, it creates good near and distance vision by combining apodized diffractive and refractive optics.

A central 3.6-mm diffractive region facilitates both near and distance vision; this gradually blends into the outer (refractive) portion of the optic through a controlled step height reduction called "apodization." When the pupil is constricted, incoming light is equally divided between near and distance vision; when the pupil is enlarged, as in low lighting conditions, the light distribution becomes distance-dominant. Clinical results are showing a reduction in the incidence of glare and halos, which the company attributes to the apodization process.

Robert P. Lehmann, M.D., clinical associate professor of ophthalmology at Baylor College of Medicine in Houston, presented the FDA clinical study results at ASCRS. The study found that 81% of patients implanted with the MA60D3 AcrySof ReSTOR lens never wear glasses (compared with 8% of those with monofocal implants). If you include patients who report "sometimes" wearing glasses, the number rises to 97%. In another arm of the FDA study, conducted by Kerry Solomon, M.D., and David T. Vroman, M.D., at the Storm Eye Institute in South Carolina, 95% of patients implanted with the lens said they'd choose to have it implanted again.

	Alcon's AcrySof Toric has shown minimal rotation in FDA clinical trials.

According to Alcon, the ReSTOR lens has the same biomaterial benefits as previous AcrySof IOLs.

The cost of the lens will probably be greater than conventional IOL technology.

AcrySof Toric. Alcon says it hopes to file for approval of the Toric version of AcrySof sometime in the next 6 months. According to the company, the AcrySof single-piece lenses are known for their centration and stability in the capsular bag -- a crucial factor for a toric IOL -- as a result of their adhesion to the capsule and a "profound shrink-wrap effect." Dots near the periphery of the lens delineate the axis of the cylinder to aid alignment on the steep meridian.

As part of the FDA clinical study, 250 AcrySof Toric implants have been evaluated for rotation. The cumulative data was presented by Paul Ernest, M.D., at ASCRS. The data showed that the mean rotation at 3 months was 4°; 83% of the implants rotated less than 5°; and none rotated more than 15°. For comparison, another popular toric lens was included in the study; 5% of those implants rotated more than 30°, enough to negate the astigmatic correction.

The company also reports that it's testing AcrySert, a pre-loaded, disposable, plung-er injector system for use with the AcrySof Single-Piece IOLs. It's possible that the new injector could reach the market by mid-2005, but the company says it's too early to say for certain.

AMO's Sensar IOL will soon join the ClariFlex in having an extended low diopter range.

Advanced Medical Optics (AMO)

AMO will be offering several new options during the coming year:

Extended diopter range. This Spring, AMO announced the availability of an extended diopter range for its ClariFlex IOL with OptiEdge. (Previously, the lens was available from +6D to +30D, in 0.5D increments; now it's also available from -10D to +5.5D in 0.5D increments.) This summer, AMO will be launching a similar range expansion for its acrylic IOL, Sensar, which also features the OptiEdge design. Like the ClariFlex, the Sensar will soon be available in 0.5D increments from -10D to +27D, and 1D increments from +27D to +30D. This will make AMO the only U.S. company offering the extended low diopter range in both acrylic and silicone.

The OptiEdge design features a squared posterior edge that creates 360° capsular contact to help prevent posterior capsular opacification (PCO), and a rounded anterior edge to reduce internal reflections by scattering light. The edge is slanted overall, to minimize the potential for edge glare.

June Cassell, director of IOL marketing at AMO, explains that the additional range is a response to market need. "Although the lenses are designed to function as standard, in-the-bag IOLs, the lower diopter lenses have a longer overall length. As a result, they fit better in the sulcus, making them ideal for piggybacking," she said. "Because of the increase in refractive surgery, we've seen more and more need for piggyback lenses when refractive patients develop cataracts and require lens replacement. Getting the precise correction is more challenging in these patients.

"In fact, the ClariFlex -- our silicone platform -- is approved for sulcus placement. The Sensar is primarily approved for bag placement, but does have the right design for use in the sulcus."

Cassell also notes that AMO will be promoting the new inserter device it recently launched for the Sensar with OptiEdge, the Emerald Ease, which functions as a syringe-style injector. (Another model, the Emerald T, is available for surgeons who prefer a threaded injector.)

Promoting the Tecnis lens. As mentioned previously, AMO is in the process of acquiring the assets of Pfizer's surgical ophthalmology business, including Pfizer's Tecnis IOL, which recently received FDA approval for new labeling claims. The lens was designed to minimize spherical aberration (which many standard IOLs actually increase), and thus improve what the company calls "functional vision" -- the ability to see well in varying light conditions. Clinical trials demonstrated that patients implanted with the Tecnis lens produced significantly better simulated night driving results and had better visual acuity as a result of reduced spherical aberration. (The new labeling states that the lens reduces postoperative spherical aberration and has improved patients' night-driving simulator performance.)

AMO was unable to comment on plans for the lens in the next 12 months because the transfer of ownership has not been completed. (The companies hope to complete the transition by this July or August.) However, Thomas J. van Haarlem, M.D., vice president of surgical ophthalmology at Pfizer, said that his company's plans for the immediate future include applying for a "new technology" designation from the Centers for Medicare and Medicaid Services (CMS), which would increase reimbursement for implanting the IOL by $50. The company is also finalizing an implanter system for the lens, and actively working to make both surgeons and organizations aware of the issue of driving safety among patients over the age of 65.

A multifocal version of the Tecnis should begin clinical trials later this year.

The next-generation Array lens. According to Jim Mazzo, president and CEO of AMO, the company will introduce a new model of the Array multifocal IOL at ESCRS this year. The new lens will use an acrylic platform and feature AMO's proprietary OptiEdge design.

B&L's forthcoming Soflex AO lens reduces positive spherical aberration compared with a conventional IOL, using a design that's not affected by decentration or tilt.

Bausch & Lomb

B&L plans to introduce two new products during the next 12 months: A new Soflex IOL designed to lessen spherical aberration, and a new "foolproof" injector system.

The Soflex AO. At the end of the year, B&L plans to add this aspheric IOL to the Soflex line of silicone lenses. (The AO stands for "Advanced Optics.") The new lens reduces spherical aberration compared with a conventional lens. According to Blake Michaels, director of cataract marketing in the United States for B&L, this lens uses a technology that should eliminate what he describes as limitations of the spherical-aberration-reducing IOL currently on the market.

The Soflex AO won't use negative spherical aberration to neutralize the positive spherical aberration created by most corneas. Instead, it will have no spherical aberration at all, positive or negative. This means most patients' vision will still be subjected to some positive spherical aberration from the cornea, but less than with conventional IOLs (which add positive spherical aberration).

According to B&L Engineering Fellow Griff Altmann, the tradeoff is that the visual performance of the Soflex lens will be unaffected if the lens is decentered or tilted in the eye. (When asked about the small amount of positive spherical aberration that will remain, Altmann points out that a low level of positive spherical aberration is normal in young healthy eyes and actually can have some benefits, including providing some level of pseudoaccommodation.)

Bausch & Lomb expects to launch the Soflex AO in November. It will work with B&L's standard silicone IOL injector, the MPort SI, a plunger-style injector that was recently improved. (The new model doesn't require pulling back the plunger before making the second push to get the IOL into the eye.) Like the previous version, it compresses the IOL into an "M" shape rather than folding it in half, allowing it to "bloom" in a controlled, planar manner, without causing an optic to sweep across the chamber.

A new "foolproof" injector system. Some time in the first half of 2005, B&L plans to launch a new injector to (eventually) replace the MPort. The IOL will come in a carrier that simply snaps into the injector, eliminating the risk of damaging the lens during loading, or loading it incorrectly.

Initially, the new injector system will only be available for B&L's top-of-the-line IOLs, although the company plans to make it available for the other Soflex lenses over time.

STAAR

STAAR is planning to launch a 3-piece version of its Collamer IOL, along with a new injection system, at the Academy meeting later this year.

A spokesperson for the company explained that the IOL is made from a polyHema-based copolymer, with 0.3% collagen. The collagen has a strong affinity for fibronectin, so it attracts a layer of fibronectin to the surface of the lens after implantation. This isolates it from the immune system, contributing to a high level of biocompatibility. At the same time, the lens has a slight negative charge, which repels proteins, preventing buildup of protein deposits. (Because of its high water content, a "ding" during YAG capsulotomy has been shown to disappear spontaneously.) The injection system will include a loading template, a special forcep, and a cartridge that fits into a titanium injector.

A new study conducted by Robert G. Martin, M.D., found that the collamer IOL has 55% to 117% fewer induced higher-order aberrations than acrylic or silicone materials; as a result, it produces less post-op glare. Another study by Elizabeth Davis, M.D., found a statistically significant reduction in the amount of flare and inflammation produced by implantation of a collamer lens, compared with an acrylic lens.

STAAR will also be introducing the K53, a preloaded, single-use silicone lens with a 6-mm optic and square edge, at the ESCRS in Paris. The lens and preloader are a joint venture between Canon and STAAR. The injector will let the surgeon choose twisting or pushing to insert the lens. A spokesperson said that there's a chance this system could be available in the United States by the middle of next year, but it's too soon to say for certain.

Also Happening This Year

Other IOL-related developments include: Surgeon credentialing. Since FDA approval of eyeonics' crystalens accommodating IOL last fall, eyeonics has conducted five Vision Enhancement System training courses for about 400 surgeons, 65 of whom are now fully credentialed to implant the lens. According to the company, more than 2,000 lenses have been implanted since approval, with "superb" results. Five more training courses are scheduled during the remainder of the year, including one in New York City on September 10th. The company hopes to have 200 fully credentialed surgeons by the end of the year. ThinOptX's Thinlens can be implanted through a 1.5-mm incision. B&L's next-generation injector system has a lens carrier that snaps into the injector, eliminating problems during loading. Rayner's C-Flex IOL remains centered in a clear capsule several months after implantation. In clinical trials. Several IOLs are under investigation: ► ThinOptX is currently setting up investigational sites for a multicenter FDA clinical trial -- the first large-scale study of the Thinlens, an ultra-thin IOL designed to be injected following microincision phacoemulsification. Enrollment of 400 patients at 10 sites should begin shortly. Because the Thinlens doesn't use a conventional optic design, it can be placed through a 1.5-mm incision, and puts minimal pressure on the incision during insertion. It uses peripheral rings to minimize the mass of the lens; the rings also correct spherical aberration in the perimeter, while minimizing spherical aberration and third-order aberrations like coma overall. The 50-micron tips of the lens haptics are designed to roll, helping to prevent decentration after implantation, and the lens has been shown to provide between 1.5 and 2 diopters of accommodation in an ongoing multisite study. The Thinlens comes with a unique inserter system, the ThinRoller Injector, that loads and places the lens in three steps, uses no viscoelastic, and does not require enlarging the 1.5-mm incision. (The company reports that the injection system is a major selling point outside the United States.) A spokesman says the company plans to bring a multifocal version of the lens, and a new Thin Phakic IOL, to clinical trial by the end of 2004. ► Eyekon Medical, based in Clearwater, Fla., has an acrylic IOL currently undergoing FDA clinical trials. The company notes that this lens is hydrophilic, very similar to the natural crystalline lens of the eye, which is expected to be a major selling point. ► The C-Flex IOL from Rayner (Hove, East Sus-sex, UK) is currently in clinical trials here in the United States. The C-Flex is a hydrophilic acrylic lens with a modified edge designed in collaboration with David Apple, M.D. Mark Packer, M.D., has been implanting the lens as part of the trials. He reports: "In my experience the lens remains exceptionally well-centered, and the capsule continues to look perfectly clear." (See photo, above.) "The patients implanted with this lens at our center have so far not complained of dysphotopsia."