TUESDAY, July 6 (HealthDay News) -- A tiny telescope that's
implanted in an eye affected by advanced age-related macular
degeneration (AMD) has been approved by the U.S. Food and Drug
Administration.
The Implantable Miniature Telescope replaces the natural lens
and magnifies an image more than two times, the FDA said in a news
release.
The device is meant for people aged 75 and older who have blind
spots associated with end-stage AMD. Candidates will be trained
with an external telescopic device to see if they may benefit from
the implanted product, the agency said.
AMD damages the eye's macula, causing vision loss in the center
of the visual field. The condition affects mostly older people,
often making it impossible to recognize faces or perform tasks such
as watching television, the FDA said. Some 8 million Americans have
been diagnosed with the condition, and about 25 percent of those
are significantly visually impaired.
The FDA said it's requiring the labeling to warn that the device
puts users at greater risk of injury to the eye's cornea.
As a condition of approval, California-based VisionCare
Ophthalmic Technologies will conduct two follow-up studies of the
device, the agency said.
More information
To learn more about AMD, visit the U.S.
National Eye Institute.