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FDA allows expansion of trial for dual-optic IOL

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IRVINE, Calif. — The Food and Drug Administration will allow Visiogen to expand its ongoing phase 3 clinical trial of the Synchrony dual-optic accommodating IOL, the company announced.

The Synchrony IOL received the European CE Mark in July 2006 and is currently being evaluated in a multicenter U.S. clinical trial. The expanded study will include 300 patients at 20 sites, a company official said.

The lens features two optics connected by a spring system. Movement of the lenses in relation to each other is meant to allow the eye to focus at near, intermediate and distance, according to the release.