[nfbwatlk] Fw: FDA clears first implantable telescope for vision

[Mike Freeman]

Nuttiness knows no bounds! Read on.

Mike

----- Original Message ----- 
From: Carl Jarvis 
To: wcb-l at wcbinfo.org 
Sent: Tuesday, July 06, 2010 8:17 PM
Subject: [Wcb-l] FDA clears first implantable telescope for vision


>From the aging and blindness committee: 

FDA clears first implantable telescope for vision 
July 6, 2010 - 6:03pm
By LAURAN NEERGAARD 
AP Medical Writer

WASHINGTON (AP) - U.S. health officials have 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, a creeping loss of central
vision that blocks reading, watching TV, eventually even recognizing faces.

The idea: Surgically insert the Implantable Miniature Telescope into one eye
for better central vision, while leaving the other eye alone to provide
peripheral vision. The brain must fuse two views into a single image, and
the Food and Drug Administration warned Tuesday that patients need
post-surgery rehabilitation to make it work.

There's little to help such advanced patients today aside from
difficult-to-use handheld or glasses-mounted telescopes, while the new
implanted telescope _ smaller than a pea _ can improve quality of life for
the right candidate, said Dr. Malvina Eydelman, FDA's ophthalmic devices
chief.

But it's only for a subset of the nearly 2 million Americans with advanced
macular degeneration, Eydelman warned: Those 75 and older, with a certain
degree of vision loss, who also need a cataract removed. In fact, 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.

"We're not giving people back 20-year-old eyes," cautioned ophthalmic
surgeon Dr. Kathryn Colby of Harvard and the Massachusetts Eye and Ear
Infirmary in Boston. She helped lead manufacturer VisionCare Ophthalmic
Technologies' study of the implant.

But by magnifying images onto more of the retina than its diseased center,
someone who before couldn't see an entire face might now miss only the nose,
Colby said.

In a 219-patient study, the FDA said 90 percent of telescope recipients had
their vision improve by at least two lines on an eye chart, and
three-quarters went from severe to moderate vision impairment.

Concern about damage to the inside lining of the cornea, the eye's clear
front covering that helps focus light, held up FDA approval for several
years. In that study, 10 eyes had serious corneal swelling, five that
required corneal transplants. FDA's Eydelman said the company proposed
candidate restrictions to minimize that risk, and will study how an
additional 770 recipients fare after sales begin.

VisionCare, of Saratoga, Calif., is seeking Medicare coverage for the
surgery and rehab costs, a package that it calls CentraSight. The company
wouldn't estimate total costs but said the device itself costs $15,000.

___

Online:

FDA: http://www.fda.gov 

VisionCare: http://www.centrasight.com 



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