August 13, 2010

By Vinny Ciancio

Smaller than a pea, a new technological marvel gives hope to some of the 8 million people in the US suffering from Age Related Macular Degeneration, (AMD). It’s called an Implantable Miniature Telescope. Recently given the “go ahead” by the US Food and Drug Administration, (FDA), VisionCare Ophthalmic Technologies, Inc will move ahead with mass production of their latest wonder.

The process is to 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 fuses two views into a single image, and the Food and Drug Administration warned Tuesday that patients need post-surgery rehabilitation to make it work.

The Implantable Miniature Telescope has been found to improve vision for those diagnosed with AMD. Two versions will first be available. One provides 2.2 times magnification, the other at 2.7. Jeffrey Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological health is quoted saying “This innovation has the potential to provide many people with an improved quality of life.”

AMD is a condition that affects the elderly. The degeneration damages the center of the retina, or Macula, resulting in loss of vision in the center of the visual field.

Kathryn Colby, MD, an ophthalmic surgeon at the Massachusetts Eye and Ear Infirmary in Boston commented that results from the FDA tests “ have proven we can place this tiny telescope prosthesis inside the eye to help patients see better and, for some, even to levels at which they can recognize people and facial expressions that they could not before.”

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.

The FDA says 219 patients were studied. 75% improved their level of vision from severe or profound impairment to moderate. There will be further studies requested by the FDA. One is to follow the health of existing patients for 2 years and the other is a new 5 year, 770 patient study to further monitor endothelial cell density and related adverse events.

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