Healthcare Industry News: corneal incision
News Release - November 7, 2007
Visiogen Achieves Full Enrollment of Synchrony(R) Subjects in Its Phase III Clinical Trial
Study Examining the Efficacy of the Synchrony 3-Dimensional Dual Optic Accommodating Intraocular Lens Has Reached Critical Recruitment GoalIRVINE, Calif.--(HSMN NewsFeed)--Visiogen, Inc. of Irvine, California, today announced the closure of enrollment in its Phase III study of the Synchrony® dual optic accommodating intraocular lens. This study is evaluating the safety and efficacy of the device and the potential for functional near, intermediate and distance vision without the use of glasses in patients after cataract surgery. The study is being conducted at 20 investigational sites in the United States.
The proprietary Synchrony system is self-contained and ready for use without the need for lens handling by means of a preloaded injector. The dual optic lens is designed to be inserted through a 3.6 – 3.8 mm clear-corneal incision. The single-piece, 3-dimensional lens unfolds in the eye upon insertion and features two optics connected by a spring system. The springs connect a 5.5-mm high power anterior optic and a 6-mm minus power posterior optic. The spring action moves the front optic and changes the eye’s focus from near to far.
“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 (PMA) to the U.S. Food and Drug Administration,” said Barbara Niksch, Vice President, Regulatory, Quality & Clinical Affairs for Visiogen.
To date, the Synchrony lens has been implanted in over 900 eyes worldwide. While the lens is currently an investigational device in the United States, it received the European CE Mark in June of 2006. Post-marketing research studies are currently underway within Europe to further evaluate Synchrony.
Visiogen recently launched its new corporate website, www.visiogen.com, an interactive educational site aimed at introducing both ophthalmologists and patients to the Synchrony lens technology.
About Visiogen
Visiogen, Inc. is focused on developing innovative products for cataract and refractive patients. Founded in Irvine, California, in 2001, Visiogen’s first commercial application, Synchrony®, a 3-dimensional dual optic accommodating intraocular lens and pre-loaded injector, is currently in clinical studies in the U.S. and has received the CE Mark in Europe. More information about Visiogen and the Synchrony technology can be found at www.visiogen.com.
Source: Visiogen
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