Saratoga, CA based VisionCare Ophthalmic Technologies, Inc. has announced FDA approval of company’s Implantable Miniature Telescope, which we have been following since 2005. The device is designed to treat end-stage age-related macular degeneration (AMD) as part of the CentraSight treatment program, in which one of a patient’s eyes is implanted with the telescope. The implant will then enlarge images, causing them to be projected onto more healthy areas of the patient’s retina. This reduces the negative effect of the AMD blind spot in the patient’s vision.
From the press release:
Results from the two U.S. clinical trials, conducted at 28 leading ophthalmic centers, have been published in peer-reviewed scientific journals including Ophthalmology, American Journal of Ophthalmology, and Archives of Ophthalmology. The pivotal clinical trial showed that patients achieved clinically meaningful gains in visual acuity and quality of life with the telescope implant.
VisionCare will conduct a post-approval study to monitor patient outcomes under commercial conditions. The principal investigator of the study is Oliver D. Schein, M.D., M.P.H., Burton E. Grossman Professor of Ophthalmology at The Wilmer Eye Institute and Professor of Epidemiology at the Johns Hopkins University Bloomberg School of Public Health. A second smaller study will follow clinical trial patients for an additional two years.
Press release: VisionCare Announces FDA Approval for First-Ever Implantable Telescope for End-Stage Macular Degeneration…
Product page: Implantable Telescope Technology…
Flashbacks: The Implantable Miniature Telescope; VisionCare’s Micro-telescope Prosthesis Close to FDA Approval; Implantable Telescope for AMD Expects FDA Approval
