With implanted telescope, people with macular degeneration regain some sight

Tuesday, August 31, 2010

To counter a leading cause of blindness in older adults, U.S. health officials have approved a first-of-its-kind technology: a tiny telescope implanted inside the eye.

Illustrated at top right is the Implantable Miniature Telescope, which aims to help in the end stages of age-related macular degeneration, an incurable disease that damages the center of the retina, or macula. This results in a creeping loss of vision in the center of the visual field and that hampers reading, watching TV, eventually even recognizing faces.

In the photo at right, an IMT has been surgically implanted. By magnifying images onto parts of the retina outside its diseased center, the device improves what the patient sees at the center of his visual field, while leaving the other eye alone to provide peripheral vision. The brain must fuse two views into a single image, and the Food and Drug Administration warns that patients need post-surgery rehabilitation to make it effective.

While there's little to help patients with such advanced disease today aside from difficult-to-use hand-held and glasses-mounted telescopes, the implanted telescope -- smaller than a pea -- can improve quality of life for the right candidate, said Malvina Eydelman, the FDA's ophthalmic devices chief.

But it's only for a subset of the nearly 2 million Americans with advanced macular degeneration, she warned: those 75 and older who have a certain degree of vision loss and also need a cataract removed.

In another warning, the FDA took the highly unusual step of requiring that patients and their surgeons sign a detailed "acceptance of risk agreement" before surgery, acknowledging potential side effects -- including corneal damage and worsened vision -- and the need for lots of testing to determine who's a candidate.

"We're not giving people back 20-year-old eyes," cautioned ophthalmic surgeon Kathryn Colby, who helped lead a study of the implant for its manufacturer, VisionCare Ophthalmic Technologies. But a patient who couldn't see an entire face before the surgery might miss only the nose after receiving the implant, Colby said.

In a 219-patient study, the FDA said, 90 percent of telescope recipients had their vision improve by at least two lines on an eye chart, and three-quarters went from severe to moderate vision impairment.

VisionCare, of Saratoga, Calif., is seeking Medicare coverage for the surgery and rehab, a package that it calls CentraSight. The company wouldn't estimate total costs connected with the procedure but said the device itself costs $15,000.

-- Associated Press

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