- The Washington Times - Friday, July 14, 2006

ASSOCIATED PRESS

In the 1970s TV show “The Six Million Dollar Man,” the strapping young astronaut got a bionic eye. A U.S. company had hoped that next year that might be your grandmother.

Not so fast, a federal advisory panel said yesterday.

A tiny telescope designed to be implanted in the eyes of some elderly patients should not receive Food and Drug Administration approval, the panel recommended on a 10-3 vote.

The agency’s ophthalmic devices panel recommended against the pea-sized bionic device for safety reasons, spokeswoman Heidi Valetkevitch said.

VisionCare Ophthalmic Technologies Inc. is seeking federal approval to sell a tiny telescope that could be implanted in the eyes of some elderly patients suffering from age-related macular degeneration.

The first-of-its-kind device is called the Implantable Miniature Telescope. The pea-sized telephoto lens could enable some patients to do away with the special glasses and hand-held telescopes they now use to compensate for the loss in central vision caused by the disease.

The miniature telescope contains two lenses that work with the cornea to create a magnified image that’s projected onto a wider area of the retina, improving central vision, according to the Saratoga, Calif.-based company. It does not work in patients who are blind.

The recommendation yesterday must now be ratified by the FDA. The agency usually follows the recommendations of its outside panels of specialists, but isn’t required to do so.

The device would be implanted in only one eye, which would provide central vision. The other eye, left untouched, would be responsible for peripheral vision, leaving the brain to combine the two views to form a single image. Getting used to that could require patients to undergo professional rehabilitation, the FDA said.

Macular degeneration typically affects the elderly. The disorder leads to a weakening or breakdown of the cells in the macula, or the bull’s-eye of the retina crucial for the straight-ahead vision needed to read, watch television and recognize faces. Patients with macular degeneration suffer from blind spots and distorted vision.

“Many people with age-related macular degeneration have great difficulty using hand-held magnifying devices. Concurrent with the aging process that affects the eye, one loses one’s strength, coordination and steadiness. By implanting the lens in the eye, it’s directly placed in the optical system of the eye and is much easier for patients to use,” said Dr. Lee Duffner, a Hollywood, Fla., ophthalmologist and American Academy of Ophthalmology spokesman.


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