VisionCare, Inc. has recently been granted an investigational device exemption from the U.S. FDA for a new U.S. clinical study to evaluate the safety and effectiveness of its telescope implant in post-cataract surgery patients.
According to VisionCare, the telescope implant is the first and only FDA approved surgical treatment for people with end-stage, age-related macular degeneration (AMD). According to current labeling, the telescope implant is contraindicated in patients with previous intraocular or corneal surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes. The new study will reportedly evaluate the safety and effectiveness of the telescope implant in patients who were previously implanted with an intraocular lens.
Selected CentraSight providers across the country are reportedly now seeking end-stage AMD patients with previous cataract surgery to determine if they might be candidates as study subjects for the telescope implant.
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