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Biotech / Medical : Staar Surgical STAA

STAA 25.26

-2.4%

Nov 3 3:59 PM EST

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To: HerbVic who wrote (21)	4/18/1999 2:35:00 PM
From: Alan A. Hicks	Read Replies (1) of 50

There were 51 papers presented by eye surgeons at the American Society of Cataract & Refractive Surgery (ASCRS) Conference last week in Seattle on ICLs and other phakic IOLs. 22 were on the STAAR ICL, 17 were on the Artisan lens (Ophtec), 2 were on the Nuvita lens (BOL), 3 studies compared these three lenses, 2 were general papers, 5 were on three other products being developed. There were also three films produced by eye surgeons on the STAAR ICL. A 400 page book has also been published by two eye surgeons with 30 additional surgeons contributing their experience with the ICL. STAAR owns the trade name to “Implantable Contact Lens” or “ICL” so the other products were referred by their generic name of “phakic IOLs”. The comparative studies found each of the different products were safe and effective although there were different issues with each them. Interest was high for the STAAR ICL. A course offered by the ASCRS on the ICL was standing room only. STAAR had 12 wetlab sessions to train surgeons how to inject the ICL led by different eye surgeons using the ICL. Every session had a long waiting list to participate. The ICL is the only phakic IOL that fits in the in the posterior chamber (between the natural lens and iris). It is also the only one made of a soft injectable material. The STAAR ICL is now in its 5th generation. It was clear from the studies the surgeons using the ICL have been working with STAAR to improve the design and surgical techniques as well to find the best uses for a variety of vision problems that cannot be treated by laser techniques (including overcorrection by laser). Potential complications identified over the last five years include cataracts if the natural lens is touched with an instrument while injecting the ICL. Also the proper size of the ICL needs to be used since every eye is a little different. There needs to be enough space in the posterior chamber for the ICL. If the lens is too small it can float around in the chamber and rub against the natural lens and potentially be a cause of cataracts. A too small ICL could also move off center which could cause problems with glare. In a small number of patients the posterior chamber is too small for an ICL. In overseas ICL implants there has been a small percentage of local opacification of the natural lens. In at least one case of scratching the natural lens the patient received an IOL. In FDA trials there have been no cases of cataracts or local opacification. STAAR feels the most recent generation of the ICL (designed with a vault over the natural lens), using the right size ICL for the patient, and learning the proper surgical techniques eliminates the potential for causing cataracts. Other problems identified are pupillary block which could lead to glaucoma. This has been found can be easily overcome by performing a simple laser iridotomy. Some advantages of the ICL include immediate results from a 5 minute procedure which requires only topical anesthetic drops. Cataract IOL surgeons can quickly learn the technique. It has highly predictable results, is long-term stable, and is reversible. The surgeons who have been using the ICL felt it was the best solution for severe myopia (11+ diopters) and hyperopia. In cases of extreme vision correction two doctors reported using LASIK and the ICL to provide up to 32 diopters of correction for myopia. The ICL for myopia should finish Phase III trials this summer. All the other phakic IOLS were anterior chamber (placed in the cornea over the iris). They are all made of hard PMMA (similar to plexiglass). This requires a large incision in the cornea, sutures and longer recovery compared to the ICL. Issues include losing cells from the cornea over time. A blow to the eye could also cause damage to eye. The Artsian has completed Phase II trials. None of the other products are in trials.

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