October 27, 2014 – Corneal implants are on the rise outside of America, but the Food and Drug Administration stands in the way of the promising new technology. Millions of Americans who live with the hassle of glasses will just have to wait or move overseas. An FDA panel found the devices to be effective, but still too risky.
From the article at NPR.org:
The surgical procedure uses a laser to make a small incision in the very front of the cornea, where the ring is placed. The results with a corneal inlay are “immediate,” says Vukich, restoring near vision right away. And there isn’t much down time for patients. He says the procedure is far less complicated and invasive than LASIK.
The KAMRA corneal inlay has been used in Europe since 2011, and is also being used in South America and Asia.
But members of an FDA advisory panel have raised concerns about the safety of the device. At the committee’s meeting in June, the company presented data from a 36-month trial that found that 83 percent of the 478 patients enrolled achieved visual acuity of at least 20/40 or better.