Eye telescope gets FDA approval
After five years, the U.S. Food and Drug Administration has finally given approval to an eye telescope that treats macular degeneration, the leading cause of blindness in the U.S. The Implantable Miniature Telescope (IMT) has been developed by VisionCare Ophthalmic Technologies, Inc. as part of Centrasight, a new patient care system which treats end-stage age-related macular degeneration (AMD).
More than 10 million people in the USA alone suffer from macular degeneration, which is the leading cause of blindness in people over 55. Of those people, 1.7 million suffer from advanced AMD, for which there has been little or no medical answers up till now. AMD is a disorder of the central retina or macula, the part of the eye that enables the clearest and most distinct vision, fundamental to abilities such as recognizing faces. For many, central vision becomes blurred or completely dark, which impedes all daily activities. The visual impairment suffered in end-stage AMD, in which both eyes are in the advanced phase of the disorder, often leads to loss of independence and patient isolation.
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The telescopic implant is designed to improve visual acuity by reducing the impact of the blind spot. The IMT, a device smaller than a pea, is surgically implanted into one cornea and acts to expand an incoming image onto the peripheral parts of the retina that are undamaged. Central vision is improved in one eye, while the other continues to receive information on peripheral vision for mobility and orientation.
The clinical trials were conducted at 28 leading ophthalmic centers and showed that patients achieved clinically meaningful gains in visual acuity and quality of life with the telescope implant. In fact, more than two-thirds of those treated reported notable improvement in vision. The commercial version of the IMT is called Centrasight and is in development by VisionCare Opthalmic Technologies, Inc.
It isn't a complete fix, however. The patient will need months of rehabilitation and occupational therapy to learn how to use the donut-shaped image the telescope provides. Some patients may not adapt well to the new vision, or might find rehabilitation too stressful. Additionally, some may suffer side-effects or damage to the cornea by the IMT. That said, the IMT is available in the USA now and can be implanted during a short thirty-five minute out-patient procedure through Centrasight. Patients should be greater than or equal to 75 years of age, with stable severe-to-profound vision impairment constituting statutory (legal) blindness.
VisionCare will conduct a post-approval study to monitor patient outcomes under commercial conditions. A second smaller study will follow clinical trial patients for an additional two years.
“This is truly a breakthrough technology for AMD patients as their treatment options have been limited until now,” said Kathryn A. Colby, an ophthalmic surgeon at Massachusetts Eye and Ear Infirmary in Boston and Assistant Professor of Ophthalmology at Harvard Medical School. “The clinical results from the pivotal FDA trial have proven we can place this tiny telescope prosthesis inside the eye to help patients see better and, for some, even to levels at which they can recognize people and facial expressions that they could not before.”
Via Singularity Hub