FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
 
T99-16                        Sharon Snider:      301-827-6242
April 9, 1999                 
                              Consumer Inquiries: 888-INFO-FDA

FDA APPROVES EYE IMPLANT TO CORRECT MILD NEARSIGHTEDNESS

FDA today approved tiny, transparent crescents that can be implanted into the eye to enable people who are mildly nearsighted to see without glasses or contact lenses.

Nearsightedness results when a person's cornea is too steeply curved. The devices, called KeraVision Intacs, consist of two half-circles made of thin acrylic material. They are surgically inserted in the periphery of the cornea, the membrane that covers the front of the eye, which results in a flattening of the cornea. This change in the shape of the cornea reduces or eliminates nearsightedness.

Nearsightedness is most commonly corrected with glasses or contact lenses. Other surgical procedures to correct nearsightedness are also available. One involves changing the corneal shape by cutting into the cornea. Another uses a laser to remove small amounts of tissue to change the shape.

Intacs are considered to be permanent implants, but they can be removed if necessary. In most cases, vision returns to its pre-surgery level, but some patients may have visual symptoms (glare, halos around lights, etc.) after removal.

FDA approved the devices, made by KeraVision Inc., of Fremont, Calif., for adults 21 and older who have mild nearsightedness ( 1 to 3 diopters of refraction), with mild astigmatism (l diopter or less), whose vision has been stable for the past year.

Approval was based on a review of safety and effectiveness data submitted by the manufacturer and on the recommendation of the Ophthalmic Devices Panel, a group of outside experts.

In clinical studies in the United States, the corneal rings were implanted in approximately 450 eyes. Initially only one eye per patient received the implant; six months later, if all went well with the first eye, the procedure could be repeated on the second eye.

After 12 months, 97 percent of the eyes were corrected to 24/40 or better and 74 percent were corrected to 20/20 or better.Some patients (39) chose to have their Intacs removed because of side effects or because they were unhappy with the corrected vision. Of those, 19 reported symptoms such as glare, halos and problems with night vision. Fifteen reported under-correction or over-correction of vision.

At FDA's request, KeraVision is continuing to collect data on patients to determine the long-term effect of the implants on the cornea.

The implants were approved for mild nearsightedness only. Their safety and effectiveness have not been established for moderate or severe nearsightedness.

####
[FDA HOME PAGE]