SARASOTA, Fla. (Feb. 14, 2013) – For the first time in Florida, a physician at Sarasota Memorial Hospital has surgically implanted the first FDA-approved telescope prosthesis for patients with end-stage macular degeneration.
Sarasota Neuro-Ophthalmologist Marc H. Levy, MD, implanted the pea-sized telescope directly into the right eye of 81-year-old Leslie Vlontis, a Venice woman with severe vision loss due to age-related macular degeneration (AMD). Dr. Levy performed the procedure in a little over an hour at Sarasota Memorial’s outpatient Cape Surgery Center on the hospital’s main campus Feb. 4.
End-Stage Age-Related Macular Degeneration is the leading cause of blindness. The disease creates a permanent central vision blind spot making it difficult or impossible to recognize even closefamily or friends.
The pea-sized implantable telescope helps improve vision in patients with the most advanced form of macular degeneration, while being virtually unnoticeable in the eye.
AMD is a condition that affects mainly older people, damages the center of the retina (macula) and results in a loss of vision in the center of the visual field. About 8 million people in the United States have AMD and nearly 2 million of them have significant vision loss, according to the National Eye Institute. It is the leading cause of irreversible vision loss and legal blindness in the US and often makes it difficult or impossible to recognize faces or perform daily tasks like reading or watching TV.
The tiny telescope – part of VisionCare Ophthalmic Technologies’ CentraSight® treatment program – is the first medical device approved by the FDA that is implanted into the eye to treat AMD, and the only treatment option for people whose AMD blindness no longer responds to medication. It was approved by the FDA in 2010, but did not become commercially available in Florida until last fall when it was approved for Medicare coverage.
“I’ve gone gray and nearly bald waiting for this day,” said Dr. Levy after today’s successful implant. “Our team was the Florida test site for this device 11 years ago, and we recognized the benefits to patients early on, both visually and psychologically. Although it’s not a cure, it is effective in restoring enough vision for people to enjoy many of the simple acts we all take for granted – pouring a cup of coffee, crossing the street safely, seeing a smile on their grandbaby’s face.”
The implant uses micro-optical technology to improve “straight ahead,” or central vision, Dr. Levy said. During surgery, the natural lens of the eye is removed and the telescope is inserted in its place. Working in conjunction with the cornea, the implant magnifies objects two to three times their normal size and projects the images beyond the scarred macula to the healthy part of the retina.
Patients who have the procedure still won’t be able to see all of the details of an object before them, but with about six to eight weeks of visual rehabilitation training, Dr. Levy says the brain can learn to put together images projected on the retina from both eyes to help them recognize faces, words on a page and pictures on a screen.
During clinical trials of the device, Dr. Levy implanted the miniature telescope in five area patients at the Cape Surgery Center between 2002-2004 and monitored their condition for the past 10 years. Three of the five patients have since passed away due to age, but he said the other two continue to enjoy better vision with their implants.
Not everyone is a candidate for the telescope. To qualify, potential patients must meet FDA age, vision and cornea health requirements. In addition, the CentraSight treatment program utilizes a multispecialty provider team approach for proper diagnosis, surgical evaluation and post-operative care. Prospective patients undergo a medical, visual, and functional evaluation prior to the surgery to assess if the benefits of the procedure outweigh the potential risks. A unique aspect of the pre-operative evaluation is the ability to simulate, prior to surgery, what a person may expect to see once the telescope is implanted to determine if the possible improvement will meet the patient’s expectations.
“It’s not an immediate fix,” Dr. Levy said. “After we implant the telescope, the patient needs to work with our low vision team and rehabilitation specialists for a number of weeks to learn how to use the telescope in every day activities.”
To hear from the doctor, patient and see video footage of this procedure, you can watch a video on Sarasota Memorial's education channel on YouTube
New Hope for Macular Degeneration
Read the Sarasota Herald-Tribune article
Sarasota physician implants telescope for macular degeneration
Read the Tampa Bay Business Journal blog article
Recently-approved eye implant sugery done in Sarasota
View the ABC7 news clip
Macular Degeneration Breakthrough
View the FOX13 news clip
The Food & Drug Administration has approved VisionCare’s Implantable Miniature Telescope (by Dr. Isaac Lipshitz) for use in patients with irreversible end-stage macular degeneration. The first-of-its-kind telescope implant is integral to CentraSight®, a new patient care program developed by VisionCare to treat patients with end-stage AMD. In its 217-patient multi-center study that spanned nearly a decade, 90 percent of patients receiving the implant achieved at least a 2-line gain in either their distance or best-corrected visual acuity, and 75 percent of patients improved their level of vision from severe or profound to moderate impairment.
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. Patients can learn more about the telescope implant, including risks/benefits, by visiting www.CentraSight.com, or calling 1-877-99SIGHT to speak with a CentraSight Information Specialist.
The implant cost is covered by Medicare, though individual states may vary in the approval process.
About Marc Levy, MD/The Sarasota Retina Institute
Marc H. Levy, MD, is a Neuro-Ophthalmologist with The Sarasota Retina Institute, which specializes in treating complex eye problems such as macular degeneration, retinal detachments, diabetic and thyroid-related eye diseases, strabismus, optic nerve diseases, ocular trauma and infections. In addition to Dr. Levy, the group’s multi-disciplinary team includes: Retina Specialists Melvin C. Chen, MD and Waldemar Torres, MD; Optometrist and Low Vision Specialist Lissa Rivero, OD; Optometrist Jeannene Dieter, OD; Low Vision Occupational Therapist Yolanda Cate; and Clinical Coordinator Peggy Jelemensky.
About Sarasota Memorial Health Care System/Cape Surgery Center
Sarasota Memorial Health Care System is a regional referral center offering Southwest Florida’s greatest breadth and depth of inpatient, outpatient and extended care services, with more than 800,000 patient visits a year. Sarasota Memorial’s 806-bed acute care hospital has been recognized repeatedly as one of the nation’s largest, safest and best, with superior patient outcomes and a complete continuum of outpatient services– including the Cape Surgery Center (same day outpatient surgery center), urgent care clinics and physician groups, laboratory and diagnostic imaging centers, to home health and skilled nursing & rehabilitation. Sarasota Memorial is the only hospital in the Suncoast region (Sarasota, Manatee, Charlotte and DeSoto counties) ever to rank in U.S. News & World Report’s “Best Hospitals” and HealthGrades “America’s 50 Best Hospitals” lists. The Cape Surgery Center is located adjacent to the main hospital.