Myopia and Implants

An implantable lens to correct the vision and ability to read of nearsighted people won approval from the U.S. Food and Drug Administration on Monday, September 13 2004.

The lens is permanently implanted in the eye and can offer an alternative to reading glasses, contact lenses and laser surgery.

The approval covers the Artisan lens made by Ophtec USA Inc. Its president Rich McCarley said the product could be available to surgeons in two weeks. He said the price has not been determined.

Unlike the implanted lenses that replace the eye's normal lens to correct cataracts, this lens is implanted in front of the natural lens. FDA said it is intended to reduce or eliminate nearsightedness or myopia in adults with healthy eyes. It should not be used in people who have more than minor astigmatism, the agency said.

The agency is requiring the company to do a follow-up five-year study of users of the lens to determine any side effects.

One possible concern, the FDA said, is the loss of endothelial cells in the corneas of patients who received the implants. These cells form a layer on the undersurface of the cornea and are essential to keeping the cornea clear.

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