U.S. OKs New Implants for the Mildly Nearsighted

Millions of mildly nearsighted Americans won a radically new way to improve their vision without glasses or contact lenses: The government on Friday approved tiny transparent rings that are implanted directly onto the cornea.

KeraVision Inc.’s Intacs implants offer an alternative for some patients to popular but irreversible laser eye surgery, at about the same price.

Nearly three out of four patients who tried the implants in clinical trials achieved 20/20 vision. But if patients don’t like their Intacs, or suffer a side effect such as glare, doctors can remove the rings with a good chance of returning the eyes to pre-surgery condition.

The Food and Drug Administration warned that the implants are only for mildly nearsighted people, whose vision is formally diagnosed as “minus 1 diopters to minus 3 diopters.” That roughly translates to vision ranging from 20/40--where it’s OK to drive but a movie is blurry without glasses--to about 20/300, where you can barely see the big “E” at the top of eye charts.

In contrast, laser surgery can sharpen the vision of people with much more severe nearsightedness.

Still, the implants are “really an interesting approach,” said Dr. Susan Alpert, FDA’s medical device evaluation chief. “It is a simple procedure.”