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Enrollment complete for trial of dual optic accommodating IOL
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IRVINE, Calif. — Enrollment has closed for a phase 3 study investigating the efficacy of Visiogen's Synchrony dual optic accommodating IOL, the company announced in a press release.
The study is evaluating the IOL's ability to improve patients' functional near, intermediate and distance vision without the use of glasses after cataract surgery at 20 sites in the United States, according to the release.
The Synchrony IOL is a single-piece, three-dimensional lens that unfolds after being inserted through a 3.6 mm to 3.8 mm clear corneal incision. The lens features a 5.5-mm high-power anterior optic and a 6-mm minus power posterior optic connected by a spring system. The spring action moves the front optic and changes the eye's focus from near to far, the release said.
"Over 300 subjects were implanted with the Synchrony lens during this study. The achievement of this major milestone for Visiogen will now allow us to focus on the follow-up phase of the study and the future submission of a premarket approval application to the U.S. Food and Drug Administration," Barbara Niksch, vice president of regulatory, quality and clinical affairs for Visiogen, said in the release.
Outside of the United States, the Synchrony lens has been implanted in more than 900 eyes. The lens received the European CE Mark in June 2006, and post-marketing research studies are currently under way there for further evaluation.