FDA Approves Intraocular Lens That Can Be Adjusted Post-Cataract Surgery
The Food and Drug Administration (FDA) has approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first device system that can adjust the artificial lens' power post-cataract surgery so that the patient can have improved vision when not using glasses.
Residual refractive error, which can occur after cataract surgery, requires the use of glasses or contact lenses to correct the blurred vision. The newly approved device system is intended for patients who have astigmatism pre-surgery and who do not have macular diseases. With the medical device, physicians can make small adjustments to the implanted lens during in-office visits following the initial surgery to improve vision; it allows for a correction of up to 2 diopters of post-op sphere and/or –0.75 to –2 diopters of residual post-op refractive cylinder.
The material of RxSight intraocular lens (IOL) reacts to UV light, which is delivered by the Light Delivery Device (LDD) about 17 to 21 days post-surgery. Over 1 to 2 weeks, patients undergo 3 or 4 light treatments, lasting 40–150 seconds each. In a clinical study (n=600), patients were evaluated for the safety and efficacy of the RxSight Light Adjustable Lens and Light Delivery Device. Study patients receiving the Light Adjustable Lens, followed by light treatment with the LDD, achieved UCVA of 20/20 or better at six months post-op at approximately double the rate of patients receiving a monofocal lens.
Also, 91.8% of patients receiving the Light Adjustable Lens achieved a result within 0.50 D of target manifest refraction spherical equivalent, which is similar to the refractive accuracy seen in recent LASIK studies. The majority of patients (75%) also had a decrease in astigmatism 6 months post-surgery.
The RxSight device system is not intended for use in patients taking systemic drugs that may increase sensitivity to UV light (ie, tetracycline, amiodarone, hydrochlorothiazide) or in patients who have a history of ocular herpes simplex virus.
For more information visit FDA.gov.