Vision-Improving Device Gets FDA Approval Leave a comment


(RxWiki News) The US Food and Drug Administration (FDA) has approved a device that can adjust to improve patients’ vision after cataract surgery.

The newly approved RxSight Inc. Light Adjustable Lens and Light Delivery Device is able to adjust an implanted artificial lens to improve the vision of patients after cataract surgery — without the need for corrective glasses or contacts.

“Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery,” said Dr. Malvina Eydelman, director of the FDA’s Division of Ophthalmic, and Ear, Nose and Throat Devices, in a press release. “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.”

Patients who develop cataracts have impaired vision because the natural lens of the eye is clouded. The common treatment is cataract removal surgery, after which surgeons usually implant an artificial lens. However, many patients still have blurry vision due to the artificial lens not focusing properly. This problem is often corrected with glasses or contacts.

However, the new RxSight device allows for the artificial lens to be adjusted, potentially eliminating the need for corrective contacts or glasses. The FDA approved the new device after a study of 600 patients showed that those using the device saw improvements in their vision after cataract surgery.

The FDA approved this device for use in patients who do not have a macular disease but do have astigmatism in the cornea before surgery. Patients taking medications that can increase sensitivity to UV light, including doxycycline, tetracycline, piroxicam and others, should not use this device. The FDA also noted that those who have a history of ocular herpes simplex virus shouldn’t use the system.

If you are concerned about changes in your vision, speak with your health care provider.

The FDA granted approval of this device to RxSight Inc.


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