Newswise — Northampton, MA -- The American Macular Degeneration Foundation (AMDF) is supporting the next phase of clinical testing of Corneal Photovitrification (CPV), a new corneal laser procedure for vision improvement in patients with late-stage, dry or wet age-related macular degeneration and other retinal disorders. Previous clinical studies have shown the painless procedure allows patients to regain several lines of useful vision, to read again, and to experience improved quality of life.
The procedure, which takes only seconds, uses a low energy laser to minimally alter the shape of the cornea, bending light rays differently and relocating them to an area just outside of an AMD patient’s damaged macula. There, functioning retinal cells capture and transmit images to the brain. Patients report instantly-improved sight, and the brain continues to adapt to this new information source, allowing vision to improve in subsequent years, in many cases. There have been no adverse reactions, complications, or patient reports of discomfort during or following the procedure.
“The treatment is easy for patients to undergo and the safety profile appears to be superior to any other surgical treatment in ophthalmology,” according to a statement by Raymond Stein, MD, FRCSC, Medical Director at the Bochner Eye Institute in Toronto, Canada, where CPV, also known as Clear-K®, is already in use.
The procedure is appropriate for late stage dry AMD patients, for whom there is no current, FDA-approved pharmaceutical treatment. It also offers vision improvement for wet AMD patients, who will continue to have to be treated with anti-VEGF drug therapy. In general, CPV can be used for low vision patients with central vision loss whose best-corrected visual acuity is between 20/60 and 20/800, including those with Best disease and Stargardt disease. It can also augment the effectiveness of assistive devices, such as magnifiers or newer head-mounted technology. CPV may also hold vision-restoring potential for those with macular holes that were unsuccessfully repaired with prior surgery, and patients with reduced central vision from macular scars. Future applications include: diabetic macular edema and myopic macular degeneration.
The investigators have also developed testing parameters that will allow them to predict, for each patient, the best expected outcome. “In reality the image shift may lead to slightly lower visual acuity than that of a healthy macula, because there are fewer cone photoreceptors in the new region,” said Michael Berry II, one of the lead investigators and CEO of the Optimal Acuity Corporation. “But when the patient has late AMD, the benefits of these image shifts outweigh any comparison to that lost central vision.”
Berry continued: “This grant from AMDF will permit us to conduct a prospective study and generate data needed to apply for a grant from the National Eye Institute -- and to provide credibility with the investment community in order to obtain funding for an FDA trial. Our hope is to gain FDA approval for the use of CPV in the United States in about two years.”
“The American Macular Degeneration Foundation is highly selective with our Breakthrough Awards,” said Chip Goehring, President and Founder, AMDF. “This development holds the potential to dramatically change the lives of so many people – and it’s already treating patients in Canada. We felt investing in its success, on behalf of the macular degeneration and low vision communities, was essential.”
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The American Macular Degeneration Foundation (macular.org) is a patient-centric foundation that supports potentially game-changing AMD research, education and advocacy in order to improve quality of life and treatment outcomes for all of those affected by AMD.