The U.S. Food and Drug Administration (FDA) said Wednesday that it has approved RxSight’s light adjustable lens and light delivery device.
The lens and device are the first medical device system approved by the FDA to make small adjustments to the artificial lens after cataract surgery.
Cataract is a common eye illness where the natural lens becomes clouded, impairing a patient’s vision. Patients often experienced some minor residual refractive error, which causes blurred vision in the artificial lens that replaces the natural lens after the surgery, requiring them to use glasses or contact lens for a better view.
However, the new treatment is expected to provide patients, who have cataract surgery, with better vision without having to wear glasses or contact lens.
The FDA approved the device after it passed the safety and efficacy clinical test on 600 patients.
The result showed, after six months, patients on average saw an improvement of about one additional line down the vision chart for distance vision without glasses compared to a conventional intraocular lens (IOL). 75 percent of the patients also had a reduction in astigmatism.
“Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery,” said Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health. “This system provides a new option for certain patients that allow 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 device is intended for patients who have astigmatism before surgery and do not have macular diseases. However, patients taking systemic medication that may increase sensitivity to ultraviolet light need to avoid the surgery as it may cause irreversible eye damage.
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