FDA OKs First Implanted Lens That Can Adjust Following Cataract Surgery
The FDA recommends the device not to be used in patients taking systemic medication that could increase sensitivity to UV light.
Officials with the US FDA have approved RxSight Inc.'s Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery.
The RxSight IOL is made of a material that reacts to UV light, which is delivered by the Light Delivery Device, 17-21 days after surgery. Patients receive 3 or 4 light treatments over a period of 1-2 weeks, each lasting about 40-150 seconds, depending upon the amount of adjustment needed. 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.
A clinical study of 600 patients was conducted to evaluate the safety and effectiveness of the RxSight Light Adjustable Lens and Light Delivery Device. Six months after the procedure, patients on average saw an improvement of about 1 additional line down the vision chart, for distance vision without glasses, compared to a conventional IOL. Six months after surgery, 75% also had a reduction in astigmatism.
The device is intended for patients who have astigmatism (in the cornea) before surgery and who do not have macular diseases. 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 device is also contraindicated in cases where patients have a history of ocular herpes simplex virus.
“Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery,” Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health said in a press release about the approval. “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.”
FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients [news release]. Gaithersburg, MD. FDA website. Accessed Nov. 22, 2017 at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586405.htm