WASHINGTON — The FDA on Wednesday approved a intraocular lens (IOL) system that can adjust the power of an artificial lens after cataract surgery so patients will see better even if they’re not using glasses.
“Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses, or refractive surgery,” said Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health, in a press release. “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 system, known as the RxSight Inc. Light Adjustable Lens and Light Delivery Device, consists of an intraocular lens and an adjustment device. The lens is made of a unique material that reacts to ultraviolet (UV) light, which is delivered by the light delivery device 17-21 days after surgery, the FDA said.
Patients then receive three or four light treatments over a period of 1 to 2 weeks, each lasting about 40-150 seconds, depending on the amount of adjustment needed, the agency said. The patient must wear special eyeglasses for UV protection from the time of the cataract surgery to the end of the light treatments to protect the new lens from UV light in the environment.
The system was approved following a clinical study of 600 patients. Six months after the procedure, patients on average saw an improvement of about one additional line down the vision chart compared to a conventional intraocular device. Six months after surgery, 75% of patients also had a reduction in astigmatism.
The device is intended for patients who have astigmatism and who do not have macular diseases, the release noted.
The device should not be used in patients taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypercin, ketoprofen, piroxicam, lomefloxacin and methoxsalen. Treatment in patients taking such medications may lead to irreversible eye damage, the agency warned. The device is also contraindicated in cases where patients have a history of ocular herpes simplex virus.
The device is made by RxSight Inc. of Pasadena, California.