The FDAs Ophthalmic Devices Panel recommended against the Implantable Miniature Telescope (VisionCare Ophthalmic Technologies Inc.), a tiny telephoto lens intended to enable some patients who have age-related macular degeneration to do away with telescopic glasses and handheld devices.
The 4mm-long prosthetic telescope contains two lenses that work with the cornea to create a magnified image that is projected onto a wider area of the retina for improved central vision, the company says. The device is implanted in only one eye to provide central vision. The non-operated eye provides peripheral vision for mobility and orientation. The brain is supposed to combine the two views to form a single image.
The Ophthalmic Devices Panel recommended against the Implantable Miniature Telescope in a 10-to-3 vote, saying the companys data did not provide reasonable assurance that it is safe and effective. Although not required to do so, the FDA typically follows the recommendations made by the panel.
Vol. No: 143:08Issue:
8/15/2006
