VisionCare Inc., now out of Saratoga, California, is reporting that the “FDA Ophthalmic Devices Advisory Panel unanimously recommended that the FDA approve, with conditions, the premarket application (PMA) for its implantable telescope for End-Stage AMD.” We have been reporting about this device, designed for advanced macular degeneration, since 2005 when it was in Phase II/III clinical trials. The fresh news will probably pave way for bionic geriatrics in the next few years.
From the product page:
The prosthetic telescope, together with the cornea, acts as a telephoto system to enlarge images 3X or 2.2X, depending on the device model used. The telephoto effect allows images in the central visual field (‘straight ahead vision’) to not be focused directly on the damaged macula, but over other healthy areas of the central and peripheral retina. This generally helps reduce the ‘blind spot’ impairing vision in patients with AMD, hopefully improving their ability to recognize images that were either difficult or impossible to see.
The prosthetic telescope is implanted by an ophthalmic surgeon in an outpatient surgical procedure. The device is implanted in one eye, which provides central vision as described above, while the non-implanted eye provides peripheral vision for mobility and navigation. After the surgical procedure, the patient participates in a structured vision rehabilitation program to maximize their ability to perform daily activities. Situated in the eye, the device allows patients to use natural eye movements to scan the environment and reading materials.
Press release: FDA Advisory Panel Recommends Approval of VisionCare’s Implantable Telescope for End-Stage Macular Degeneration
VisionCare technology page…
Flashbacks: VisionCare’s Micro-telescope Prosthesis Close to FDA Approval; The Implantable Miniature Telescope…