News from AAO not just about hottest refractive technologies

Major manufacturers are developing custom LASIK tools while also introducing new products for retina, glaucoma, information management.

[Editor’s note: Due to an oversight, the article “Industry strong at this year’s AAO” in the December 1 issue included several paragraphs from an uncorrected draft. As the passages concerning CIBA Vision contained errors of fact, that portion of the article is being reprinted below in its correct form. Ocular Surgery News regrets any confusion caused by this error.]

DALLAS — The most recent annual meeting of the American Academy of Ophthalmology (AAO) was not quite dominated by news about laser in situ keratomileusis (LASIK), but most of the buzz was still in the area of refractive surgery.

CIBA Vision broadens

CIBA Vision had some early words about non-laser refractive products that it has in the pipeline, but the company’s major announcement was the return to market of its foldable intraocular lens.

The MemoryLens has now been reintroduced to the U.S. market following its September return in Europe. Trace remnants of polishing compounds on some lenses led to inflammatory reactions in about one in 1,000 patients who received the lens, according to CIBA Vision, prompting the company to voluntarily withdraw the lens from the market. Since then, the manufacturing processes for the MemoryLens have been modified in order to eliminate the problem.

“There have been some misleading reports that there was a problem inherent in the lens material,” CIBA Vision surgical business unit president David Bailey told Ocular Surgery News. “That is just not true. The MemoryLens material is one of the best on the market.”

Patients who receive the newly manufactured MemoryLens will be enrolled in a study to verify that the lens is again giving satisfactory results.

Close follow-up planned

“Under the direction of the FDA, we will be closely following 390 patients in the U.S. and Europe to make sure we’re not getting any inflammation,” Mr. Bailey said. “We will also be conducting a telephone follow-up of the first 1,000 patients who receive the MemoryLens. We are happy to do this to assure the surgeons who use our lens that it is safe.”

The next step for the MemoryLens will be the introduction of the new model CV232 that comes pre-rolled more tightly for implantation through a smaller incision. In order to avoid unnecessary delay in reintroducing the MemoryLens, however, the company decided to reintroduce the standard model U940S before launching the tighter-roll version.

Phakic IOL possibilities

CIBA Vision announced at the AAO that it has acquired three patents from Georges Baikoff, MD, for foldable phakic anterior chamber intraocular lens designs to correct not only myopia and hyperopia but also presbyopia.

“We are very excited about this new technology,” Mr. Bailey said. “We think that the MemoryLens material combined with these anterior chamber designs will be a very successful combination.”

That anterior chamber lens initiative complements another refractive implant that was the subject of several presentations in the CIBA Vision booth — the PRL. This posterior-chamber phakic implant is being developed by Medennium Inc. CIBA Vision took a 10% equity stake in Medennium in July and now holds exclusive worldwide marketing and distribution rights to the lens, which is currently in phase 2 clinical trials.

“We are taking a strong position in phakic IOLs,” Mr. Bailey said, “and we'll be strengthening that position with more new technology.”

New from Nidek

Nidek came to the AAO meeting with announcements about new products coming to the U.S. market and new indications for existing products.

The company had just filed a supplemental premarket approval application for the EC-5000 excimer laser to perform LASIK for the correction of hyperopia and hyperopic astigmatism. Further down the development pipeline is customized ablation with the EC-5000, the first case of which was performed by Arturo Chayet, MD, according to a Nidek press release. Just before the AAO meeting, Dr. Chayet performed an aspheric ablation to correct myopic astigmatism in a patient in his Tijuana practice.

Also in the days leading up to the meeting, a 510(k) application was filed for the OPD Scan. This instrument performs Placido-disk corneal topography and wavefront analysis by infrared skiascopy. Instead of using a grid pattern of dots as in other types of aberrometry, the OPD Scan projects infrared light through rotating slit-shaped apertures and analyzes the retinal reflex image.

The ultimate goal, according to David Yeh, national director of sales for Nidek, is for these various new refractive instruments to converge via the company’s Final Fit software. The patient's refractive status would be assessed by the OPD Scan; that data would be fed directly into the Final Fit software, which would analyze the data and develop a surgical plan; and that plan would be programmed directly into the EC-5000 as a custom LASIK ablation.

Info management service

Although that integrated surgical system will take some time to bring to market, Nidek announced the launch of a new alliance in which TotalEyeSight.com will provide a Web-based “integrated marketing, operational and logistics infrastructure” to EC-5000 users.

The services offered by TotalEyeSight.com are centered on the company’s The Practice Zone software. This package not only lets medical practices set up their own Web sites using a variety of patient information pages, but can also take over the e-mail, appointment scheduling, purchasing and refractive surgery financing operations of the practice. An electronic calendar in The Practice Zone is accessible by portable telephones with wireless access protocol.

Zeiss Humphrey expands

In addition to being a major original equipment manufacturer for the rest of the ophthalmic industry, Zeiss Humphrey is becoming an even bigger presence with its expanding line of house-brand products.

The success of its longstanding product lines such as slit lamps, lasers and phaco machines — as well as this year’s launch of the IOLMaster and the Visulas 690s laser for photodynamic therapy — put 2000 revenues nearly 50% ahead of 1999 sales figures, Zeiss Humphrey president Lothar Koob told Ocular Surgery News. The company looks forward to another strong year with even more new products introduced at the AAO.

Although not a new product per se, the new generation Optical Coherence Tomography Scanner, the OCT2, might now have its “killer application” in glaucoma. The Humphrey Field Analyzer and newer FDT frequency-doubling visual field instrument are already well-established in glaucoma practice, and the Glaucoma Analysis Package for the OCT2 is designed to complement that line.

“When you do a weather forecast,” Mr. Koob said, “do you just measure the wind? In glaucoma, people are interested in early, customized diagnosis.” The unique imaging capabilities of the OCT2, combined with a normative database and software to analyze retinal changes, are designed to make that early diagnosis possible.

Another new addition to the Zeiss Humphrey line is the QuantumLight wavefront refractor. This instrument uses Hartmann-Shack aberrometry to perform a wavefront analysis of the refractive state of the eye. An application for customized LASIK ablation is currently being developed in collaboration with Alcon Summit Autonomous.

All of these diagnostic imaging devices can now be linked with another new Zeiss Humphrey product, the Ensemble analysis system. This computer system gives physicians access to all of the visual field, corneal topography, lensometry and refraction data gathered by Zeiss Humphrey instruments and is also set up as an open architecture to work with instruments from other manufacturers.

IntraLase targets keratomes

Just when the market for microkeratomes seemed saturated last spring, a whole new class of flap-maker opened up.

The Pulsion FS is a solid-state, infrared femtosecond laser approved in the U.S. for making LASIK flaps. This unique instrument performs intrastromal tissue disruption by focusing the laser energy within corneal tissue. A 5-µm bubble is created with each laser burst, which the Pulsion FS connects in an outwardly spiraling pattern at a rate of 10,000 per second. A suction ring and disposable applanating contact lens attachment couple the eye to the laser as a cleavage plane is created within the cornea. When the circular pattern is complete, the laser then works around the periphery of the flap to cut it free.

“Doctors can be certain of getting a consistent flap all the time, which reduces the chances for induced astigmatism,” said Lee Nordan, MD, in a press release from IntraLase, the manufacturer of the Pulsion FS. “As a surgeon, I greatly appreciate the safety and precision of the femtosecond laser.”

In addition to Dr. Nordan, Stephen Slade, MD, Mark Speaker, MD, John Doane, MD, and Imola Ratkay-Traub, MD, described their work with the Pulsion FS to large crowds at the IntraLase booth throughout the AAO meeting.

Ironically, the effort to eliminate the microkeratome from LASIK is now being headed by two of the people that helped make the original Chiron ACS microkeratome the market leader. IntraLase president and chief executive officer J. Randy Alexander, along with vice president of sales and marketing Eric Weinberg, were key members of the Chiron Vision team that marketed the ACS.

Although the initial approval for flap-making was a milestone for IntraLase, the ultimate goal is an all-laser technique: IntraLASIK. Rather than creating a flap for conventional excimer ablation of the stromal bed, the Pulsion would create two stromal cleavage planes that met around their diameters — effectively making a free lenticle of cornea that could then be pulled out through a small laser-made keratotomy.