The FDA gave its okay to RxSight’s implantable, light-adjustable intraocular lens that can make small adjustments that provide better vision for cataract surgery patients when they aren’t using glasses.
The device uses a UV light reactive material that is treated by a specific Light Delivery Device over the course of one to two weeks (usually three to four light treatments) after cataract surgery is performed. The patient wears special eyeglasses for UV protection from the time of the cataract surgery until the light treatments are completed to protect the new lens from UV light in the environment.
“Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery,” Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health, said in a statement. “This system provides a new option for certain patients that allows the physician to make small adjustments to the implanted lens during several in-office procedures after the initial surgery to improve visual acuity without glasses.”
The regulatory agency clearance was granted based on a 600-patient clinical study that evaluated the safety and effectiveness of the RxSight Light Adjustable Lens and Light Delivery Device. On average, six months after the procedure patients reported an improvement of about one additional line down the vision chart for distance vision without glasses, compared to a conventional IOL. Six months after surgery, 75% experienced a reduction in astigmatism.
The device is intended for patients who have astigmatism within the cornea before surgery and who do not have macular diseases.