Adjustments of the artificial lens allows patients to have better vision when not utilizing glasses.
The US Food and Drug Administration has approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that makes small adjustments to the artificial lens’ power after cataract surgery, allowing patients to have better vision when not utilizing glasses.
The approval is based on a clinical study of 600 patients that was conducted to evaluate the safety and effectiveness of the device. Approximately 6 months after the procedure, on average, patients saw an improvement of about 1 additional line down the vision chart, for distance without glasses compared to a conventional intraocular lens (IOL).
“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, 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.”
Following cataract surgery, when the natural lens is replaced with an artificial lens, many patients have minor residual refractive error requiring the use of glasses or contact lenses. Refractive error, caused when the artificial lens does not focus properly, causes blurred vision.
The RxSight IOL is comprised of a unique material that reacts to UV light which is delivered by the Light Delivery Device 17—21 days after surgery.
Patients receive 3—4 light treatments over a period of 1–2, each lasting 40–150 seconds, depending on the amount of adjustment required.
The patient is required to wear specific eyeglasses for UV protection from the time of cataract surgery to the end of light treatments, protecting the new lens from UV light in the environment.
The device is intended for patients with astigmatism in the cornea before surgery, and do not have macular diseases. In the clinical study, about 75% of participants also had a reduction in astigmatism.
The FDA recommends the device not to be used in patients taking systemic medication that could increase sensitivity to UV light like tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypercin, ketoprofen, piroxicam, lomefloxacin and methoxsalen.
Treatments in patients taking any of the above medications may lead to irreversible eye damage.
The device is contraindicated in cases where patients have a history of ocular herpes simplex virus.
A press release has been made available.