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STAAR commissions team to study Collamer material for accommodating IOLs
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MONROVIA, Calif. — STAAR Surgical has assembled a team of seven leading ophthalmic surgeons to perform a three-phase evaluation of the accommodative properties of the company's Collamer lens technology, STAAR announced in a press release.
The panel, called CAST (Collamer Accommodating Study Team), will begin the first phase of its evaluation with the launch of the Collamer aspheric single-piece lens. The researchers will then collect baseline accommodative, near and distance visual acuity data from patients implanted with the lens.
During the second phase, the CAST team will evaluate changes STAAR has engineered to maximize the accommodative capabilities of the lens against the baseline accommodative data collected from phase 1. Because STAAR does not expect these changes to require supplemental premarket approval from the U.S. Food and Drug Administration, the redesigned lens could be available in 2009, the release said.
Once the second phase of the evaluation has been completed, the company will decide whether to apply for an accommodative labeling claim from the FDA.
The third phase will involve a newly designed Collamer lens, necessitating a full clinical study that will require approval from the FDA to commercialize the device and make accommodative claims in the U.S.