Ophthalmic Consultants of Long Island (OCLI) today announced it is participating in a nationwide, post-approval study of the CentraSight telescope implant, a medical device already approved by the FDA to restore vision and improve quality of life in people living with end-stage age-related macular degeneration (AMD) and meeting specific vision and cornea health criteria. The study is designed to corroborate the safety data submitted to the U.S. Food and Drug Administration that led to approval and evaluate the patient care program in a commercial setting. OCLI is actively seeking patients to participate in the CentraSight treatment program.
Smaller than a pea, the telescope implant uses micro-optical technology to magnify images, which would normally be seen in one’s straight ahead vision. The images are projected onto the healthy portion of the retina not affected by the disease, making it possible for patients to see or discern the central vision object of interest.
The CentraSight program has been developed to help patients see the things that are important to them, regain independence, and re-engage in everyday activities. The program utilizes a multispecialty provider team approach to help patients follow the necessary steps for proper diagnosis, surgical evaluation, and postoperative care. The specially trained team includes a retina specialist, cornea surgeon, low vision optometrist and low vision occupational therapist, the latter whom works with the patient over several months to teach them how to use his/her new vision. The telescope implant is the only approved surgical device for end-stage AMD and the treatment is Medicare eligible.
“OCLI has been offering the telescope implant to patients in Rockville Centre since 2013,” said Tom Burke, CEO, OCLI. “We’ve been impressed with patients’ progress following the out-patient procedure as they become proficient in using this remarkable, implanted device. Patients report they are resuming hobbies, living more independently and, most importantly, seeing the faces of their family and friends.”
About End-Stage AMD
More than 15 million Americans are affected by some form of macular degeneration and approximately 2 million Americans have advanced forms of AMD with associated vision loss. The number of Americans afflicted with macular degeneration is expected to double with the rapid aging of the U.S. population. Specifically, end-stage AMD results in a loss of central or “straight-ahead” vision, creating a blind spot, and is uncorrectable by glasses, drugs or cataract surgery. This blind spot makes it difficult or impossible for patients to see faces, read, and perform everyday activities such as watching TV, preparing meals, and self-care. The telescope implant has been demonstrated in earlier clinical trials to improve quality of life for those with central vision loss in both eyes by improving patients’ vision so they can see the things that are important to them, increase their independence, and re-engage in everyday activities. It also may help patients in social settings as it may allow them to recognize faces and see the facial expressions of family and friends.
OCLI is actively seeking patients whom might be candidates for the telescope implant. Upon contacting OCLI, patients will be evaluated for the study participation by determining if they:
· Have irreversible, End-Stage AMD resulting from either dry or wet AMD in both eyes
- Are no longer a candidate for drug treatment
- Have not had cataract surgery in the eye where the telescope will be implanted and have adequate peripheral vision in the eye not scheduled for surgery
- Are age 75 or older and meet other vision/cornea health requirements
The CentraSight treatment program includes Glenn Stoller, MD, a fellowship trained retina, vitreous and macula specialist who coordinates the treatment; Gerard D’Aversa, MD, a fellowship trained corneal, cataract and refractive surgeon who performs the surgery at South Nassau Communities Hospital and coordinates the post-surgical rehabilitation for the patient.
The telescope implant is not a cure for End-stage AMD. As with any medical intervention, potential risks and complications exist with the telescope implant. Possible side effects include decreased vision or vision impairing corneal swelling. The risks and benefits associated with the telescope implant are discussed in the Patient Information Booklet available at www.CentraSight.com.
Patients and physicians can find more information about the telescope implant and related treatment program by calling OCLI at 1-866-SEE-OCLI (1-866-733-6254) or by visiting www.CentraSight.com or calling 1-877-99-SIGHT.