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

Kaye Kipp kkipp123 at msn.com
Wed Jul 7 04:40:39 UTC 2010

Good Lord.  You're right.  It's nutty.

----- Original Message ----- 
From: "Mike Freeman" <k7uij at panix.com>
To: "NFB of Washington Talk Mailing List" <nfbwatlk at nfbnet.org>
Sent: Tuesday, July 06, 2010 8:31 PM
Subject: [nfbwatlk] Fw: FDA clears first implantable telescope for vision

> 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
> 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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