An Implantable Miniature Telescope (IMT), about the size of a pencil eraser, could be an answer for people suffering from severe macular degeneration, a leading cause of blindness affecting more than 10 million Americans.
The device, said to improve vision acuity approximately three lines on an eye chart, has received unanimous recommendation for approval from an FDA advisory panel.
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The IMT was invented by VisionCare Opthalmic Technologies (VisionCare) company founders Yossi Gross and Isaac Lipshitz. The device is currently in the midst of a two-year, multi-center phase II/III clinical research trial in the United States.
Kathryn Colby, an eye surgeon at the Massachusetts Eye and Ear Infirmary in Boston helped develop the surgical procedure used to implant the device. She said, "This is one of the few options for people with end-stage macular degeneration."
Cataracts, which many AMD patients have, are removed first. Then the telescope is inserted and held in place by surrounding tissue. The IMT is only implanted in one eye so that patients may use the eye with the implant for center-field vision and the untreated eye for peripheral vision.
Because the procedure requires a larger that usual incision, loss of endothelial cells is a concern. Endothelial cells do not regenerate and are used in keeping the cornea transparent. Scientists, however, believe that cell loss stabilizes over time.
Macular degeneration typically affects people 65 and older and eventually results in blindness. The irreversible disease affects the macula, the part of the retina required for visual activity such as reading and recognizing faces. To date, no treatments have been available for the end-stage of the disease, a category covering nearly 70,000 people per year.
The FDA advisory panel news is welcomed by VisionCare. When approved, estimated late 2009, the firm plans to market the device. It has already been approved for use in Europe, but the company plans to launch the product first in the United States.
Allen W. Hill, President/CEO currently runs the privately held company based in California.