FDA approves eye implant to correct presbyopia in middle age
(HealthDay)—An implant that helps the aging eye focus on small print and nearby objects has been approved by the U.S. Food and Drug Administration.
The implant is placed in the cornea of one eye in patients with presbyopia. It resembles a tiny contact lens smaller than the eye of a needle. It is approved for use in individuals aged 41 to 65 who have not had cataract surgery, can't focus clearly on near objects or small print, and require reading glasses with +1.50 to +2.50 diopters of power, the FDA said. But these patients do not need glasses or contacts for long-distance vision.
The FDA's approval of the Raindrop implant—made by California-based Revision Optics, Inc.—is based on a clinical trial of 373 patients. Two years after receiving the implant, 92 percent of the patients were able to see with 20/40 vision or better at near distances with the implant, according to the FDA.
The implant can cause or worsen problems with glare and halos, the FDA added. And there is a risk of developing infections that may cause complications of the cornea, such as corneal scarring, swelling, inflammation, thinning, clouding, or melting. Some patients may require a second surgery to remove or replace the inlay, the agency said.
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