• By Anni Griswold
    U.S. Food and Drug Administration
    Cataract/Anterior Segment, Refractive Mgmt/Intervention

    RxSight Inc. announced the approval of a first-of-its-kind system that can correct minor residual refractive errors by making postoperative adjustments to the IOL power. The photosensitive IOL, called the Light Adjustable Lens, and its accompanying light delivery device was cleared by the FDA on November 22.

    “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.

    The device is intended for patients who have astigmatism within the cornea before surgery and who do not have macular diseases.

    Surgeons implant the RxSight lens after cataract surgery and then fine-tune its power during 3 to 4 follow-up treatments, which begin about 3 weeks after the initial procedure. During these sessions, the physician uses a light delivery device to activate the UV-sensitive lens material and adjust the power. Patients don protective eyewear to prevent inadvertent exposure to UV light during the 1- to 2-week course of light treatment.

    A study of 600 patients suggests the lens is safe and effective: Six months after surgery, patients with the implantable lens showed a 1-line improvement on the vision chart, compared with those who received conventional IOLs. About 75% of participants also showed an improvement in astigmatism.

    “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,” Eydelman said.