FDA Approves implanted lens for nearsightedness

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FDA approves implanted lens for nearsightedness

 

 

Monday, September 13, 2004 Posted: 1:49 PM EDT (1749 GMT)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

http://www.cnn.com/2004/HEALTH/09/13/implantable.lens.ap/index.html

 

 

 

 

 

 

 

 

 

 

 

 

 

 

WASHINGTON

(AP) -- An implantable lens to correct the vision of nearsighted people

won approval from the Food and Drug Administration on Monday.

The lens is permanently implanted in the eye and can offer an

alternative to glasses, contact lenses and laser surgery.

The

approval covers the Artisan lens made by Ophtec USA Inc., of Boca

Raton, Florida. Ophtec 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 in adults with healthy eyes. It should not be used in

people who have more than minor astigmatism, the agency said.

FDA

said Ophtec studied use of the lens in 662 patients with moderate to

severe nearsightedness at 22 medical centers. After three years, 92

percent had 20/40 or better vision, which is considered standard vision

necessary to obtain a driver's license, and 44 percent had 20/20 or

better.

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, 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.

In the tests, there was a steady loss of

endothelial cells of 1.8 percent a year. Officials said it is not known

whether this loss will continue at the same rate, or what the long-term

effect of this device on the cornea's health might be. The FDA is

requiring the lens label to specify it be used only in patients with a

dense enough layer of these cells to stand some loss over time.