VisionCare Ophthalmic Technologies announced that the Food and Drug Administration (FDA) has approved the Implantable Miniature Telescope for patients with bilateral end-stage age-related macular degeneration (AMD) aged ≥65 years.
The implant was initially approved for patients aged ≥75 years monocular implantation to improve vision in patients 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.
The FDA’s expanded approval was based on clinical data from the IMT-002, a safety and efficacy study; and from IMT-002-LTM and IMT-002-LTME, two long-term studies that followed patients to 5 and 8 years, respectively. The telescope projects images in the patient’s field of view onto healthy areas of the central retina outside of the degenerated macula. The magnification reduces the effect the blind spot has on the central vision.
The Implantable Miniature Telescope is part of the company’s treatment program called CentraSight, which guides patients in following the the steps for proper diagnosis, surgical evaluation, implantation, and postoperative care.
For more information call (877) 99-SIGHT or visit CentraSight.com.