Telescope Implant and Treatment Program - CentraSight™ - Targets Leading Cause of Blindness in Older Americans
SARATOGA, Calif., Nov. 17, 2010 /PRNewswire/ -- VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices, today announced the Implantable Miniature Telescope (by Dr. Isaac Lipshitz), designed to improve vision in patients with end-stage age-related macular degeneration (AMD) is named "Best of What's New" 2010 by Popular Science magazine. VisionCare's first-of-kind telescope implant is integral to a new patient care program, CentraSight™, for treating patients with end-stage macular degeneration - the most advanced form of AMD and the leading cause of blindness in older Americans in the U.S. The telescope implant is the first and only treatment for AMD patients who progress to end-stage disease.
Through a rigorous screening process, Popular Science magazine evaluated companies and products in eleven different categories to identify innovations with potential to positively impact the future and push the envelope of what was not thought to be possible in the previous twelve months. Annually, Best of What's New honors the top 100 innovations. VisionCare's telescope implant is a Best of What's New winner in the health category in the December issue of the magazine that appears on stands today. Smaller than a pea, the telescope implant earned U.S. Food and Drug Administration (FDA) approval on July 1, 2010.
"We are very pleased our telescope implant is being recognized by Popular Science magazine as Best of What's New 2010. After years of scientific and clinical development, we are excited to provide this new technology and related CentraSight treatment program to patients and the ophthalmic community," said Allen W. Hill, President and CEO of VisionCare Ophthalmic Technologies, Inc. "Our implantable telescope has the potential to provide highly significant improvements in both vision and quality of life in patients living with end-stage AMD."
The Telescope Implant Improves Vision
The telescope implant is designed to improve visual acuity. The magnification provided by the implant reduces the impact of the blind spot caused by end-stage AMD. End-stage AMD causes severe to profound central vision loss 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.
"This micro-optical telescope is a medical marvel not only because it is a tiny Galilean telescope we can implant inside the eye, but because it can help our most severely visually impaired AMD patients gain meaningful vision," said Kathryn A. Colby, M.D., Ph.D., ophthalmic surgeon at Massachusetts Eye and Ear Infirmary in Boston and an Assistant Professor of Ophthalmology at Harvard Medical School.
"We finally have a technology available to provide a new treatment option for AMD patients who have progressed to end-stage disease," said Julia A. Haller, M.D., Ophthalmologist-in-Chief of the Wills Eye Institute, and Professor and Chair of the Department of Ophthalmology at Jefferson Medical College, Philadelphia, PA. "The telescope implant can help patients regain independence we take for granted and to go about social activities that keep us engaged with friends and the community."
Upon receiving the telescope in 2003 during the clinical investigations, Marian Orr's vision and lifestyle dramatically improved. Previously, the now 80 year old resident of Charlotte, NC, had to retire from her position as a law office bookkeeper because she lost her straight-ahead vision as a result of AMD. Now, she is able to read, watch TV and live alone. She says, "My dad and his brother were blind in their later years and I didn't want to be like that. The telescope implant has changed my life."
Results from the two U.S. clinical trials, conducted at 28 leading ophthalmic centers and published in peer-reviewed scientific journals including Ophthalmology, American Journal of Ophthalmology, and Archives of Ophthalmology showed that patients achieved clinically meaningful gains in visual acuity and quality of life with the telescope implant.
CentraSight Treatment Program
The first-of-kind telescope implant is integral to a new patient care program, CentraSight, for treating patients with end-stage macular degeneration. The CentraSight treatment program involves a patient management process and access to reimbursement resources for patients and physicians. The telescope implantation is performed by a specially trained ophthalmic surgeon as an outpatient procedure.
Patients and physicians can find more information about the telescope implant and related treatment program at www.centrasight.com.
VisionCare submitted an application to the Centers of Medicare and Medicaid Services for a new code to establish Medicare beneficiary access to this implantation procedure. It is anticipated that CentraSight evaluations and surgeries will commence shortly after Medicare finishes its code evaluation.
About the Telescope Implant
The Implantable Miniature Telescope (by Dr. Isaac Lipshitz) 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. This level of visual impairment constitutes statutory (legal) blindness.
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.
The most common risks of the telescope implantation surgery include inflammatory deposits or precipitates on the device and increased intraocular pressure. Significant adverse events include corneal edema, corneal decompensation, corneal transplant, and decrease in visual acuity. There is a risk that having the telescope implantation surgery could worsen your vision rather than improve it. Individual results may vary. More information about the risks and benefits associated with the telescope implant are discussed in the Patient Information Booklet available at www.centrasight.com.
About End-Stage Macular Degeneration
AMD is a disorder of the central retina, or macula, which is responsible for detailed vision that controls important functional visual activities like recognizing faces and watching television. The National Eye Institute estimates that over 1.7 million Americans over age 50 suffer vision loss from advanced AMD, which frequently culminates as end-stage AMD (visual impairment due to untreatable advanced AMD in both eyes). These patients often experience a loss of independence and social isolation, and have difficulty with activities of daily living. Approximately half of the individuals living with advanced AMD are affected in both eyes.
About VisionCare Ophthalmic Technologies, Inc.
VisionCare Ophthalmic Technologies, Inc., headquartered in Saratoga, CA, is a privately-held company focused on development, manufacturing, and marketing of implantable ophthalmic devices and technologies that are intended to significantly improve vision and quality of life for individuals with untreatable retinal disorders. VisionCare's Implantable Miniature Telescope was invented by company founders Yossi Gross and Isaac Lipshitz. Information on VisionCare can be found at www.visioncareinc.net.
SOURCE VisionCare Ophthalmic Technologies, Inc.