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RxSight Gets Approval for First Post-Cataract Surgery Adjustable Lens Device

First intraocular device that can adjust the lens' power after cataract surgery (Image: Evolutis)

Cataracts are a common condition in which the eye’s natural lens becomes clouded and impairs vision. Following cataract surgery, during which the natural lens of the eye is removed and replaced with an artificial intraocular lens (IOL), many patients have some minor residual refractive error requiring use of glasses or contact lenses.

RxSight, privately held and based in Pasadena, California, received FDA approval just before Thanksgiving for its 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 so that the patient will have better vision when not using glasses. The device is intended for patients who have astigmatism in the cornea before surgery and who do not have macular diseases.

Source: RxSight, formerly known as Calhoun Vision

Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery. 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.

– Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health

The RxSight IOL 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. Patients receive three or four 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 in the environment.

A clinical study of 600 patients was conducted to evaluate the safety and effectiveness of the RxSight device. Six months after the procedure, patients on average saw an improvement of about one additional line down the vision chart, for distance vision without glasses, compared to a conventional IOL. Six months after surgery, 75% of patients had a reduction in astigmatism.

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