VisionCare Announces FDA Approval for Implantable Telescope for End-Stage Macular Degeneration

July 7, 2010

VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices, yesterday announced that the FDA had approved the company’s Implantable Miniature Telescope (by Dr. Isaac Lipshitz) to improve vision in patients with end-stage age-related macular degeneration (AMD). VisionCare’s telescope implant is integral to a new patient care program, CentraSight, for treating patients with end-stage macular degeneration.

The telescope is indicated for monocular implantation to improve vision in patients greater than or equal to 75 years of age with stable severe to profound vision impairment (best-corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas (blind areas) associated with end-stage AMD (for patients, endstage AMD causes severe to profound central vision loss constituting statutory blindness in both eyes due to either wet AMD that has progressed to scarring of the macula despite drug treatments, or dry AMD that has progressed to geographic atrophy, the most advanced form of dry AMD). The magnification provided by the implant reduces the impact of the blind spot caused by end-stage AMD.

Smaller than a pea, the telescope is implanted in one eye in an outpatient surgical procedure. In the implanted eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation.

One of the risks disclosed with implantation is that the large size of the telescope may cause extensive loss of corneal endothelial cells, which can lead to corneal edema, corneal decomposition, and a need for corneal transplant.

Read the full press release here.




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