FDA Approves Implantable Telescope To Help Patients With Age-Related Macular Degeneration.
The AP (7/7, Neergaard) reports that the FDA has “approved a first-of-its-kind technology to counter a leading cause of blindness in older adults — a tiny telescope implanted inside the eye.” The Implantable Miniature Telescope “aims to help in the end stages of incurable age-related macular degeneration,” although the FDA “warned Tuesday that patients need post-surgery rehabilitation to make it work.” Dr. Malvina Eydelman, FDA’s ophthalmic devices chief, said the device can improve the quality of life for those who are 75 and older, have a certain degree of vision loss and who also need a cataract removed. In addition, “the FDA took the highly unusual step of requiring that patients and their surgeons sign a detailed ‘acceptance of risk agreement’ before surgery, acknowledging potential side effects — including corneal damage and worsened vision — and the need for lots of testing to determine who’s a candidate.”
The San Jose Mercury News (7/7, Johnson) notes, “In a study involving more than 200 patients implanted with the device, the FDA said, 75 percent ‘improved their level of vision from severe or profound impairment to moderate impairment.'” NPR’s (7/6, James) “Two-Way” blog also covered the story.