Implanted Lens Corrects Nearsightedness

But trials unearth potential risk

MONDAY, Sept. 13, 2004 (HealthDayNews) -- The U.S. Food and Drug Administration has approved a new, plastic lens that is permanently implanted into the eye to correct moderate to severe nearsightedness.

Called an intraocular lens, it is similar to the type of lens implanted in the eye to restore vision following cataract surgery.

The lens is intended to reduce or eliminate nearsightedness in adults, and will offer people another alternative to glasses, contact lenses and laser surgery, the FDA said. It is manufactured by Ophtec USA Inc., of Boca Raton, Fla.

Ophtec studied use of the lens, called the Artisan, in 662 patients with moderate to severe nearsightedness at 22 medical centers in the United States. After three years, 92 percent had 20/40 or better vision -- the standard vision needed to obtain a driver's license -- and 44 percent had 20/20 or better, the FDA said.

The lens is designed for use in healthy eyes, in people with stable vision. One potential problem raised by the Ophtec studies was the loss of endothelial cells in the corneas of patients who received the implants. The endothelium is a layer of cells that line the undersurface of the cornea and are essential to keeping the cornea clear. Three-year testing showed a loss of endothelial cells of an average 1.8 percent, the FDA said.

To learn more about nearsightedness, visit the National Library of Medicine.

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