FDA approves RxSight’s adjustable implanted lens for cataract

24 November 2017 (Last Updated November 24th, 2017 09:30)

The US Food and Drug Administration (FDA) has approved intraocular technology provider RxSight’s Light Adjustable Lens and Light Delivery Device for patients with cataract.

The US Food and Drug Administration (FDA) has approved intraocular technology provider RxSight’s Light Adjustable Lens and Light Delivery Device for patients with cataract.

The system is indicated for patients with astigmatism in the cornea before surgery and without macular conditions.

Existing artificial lenses are reported to retain minor residual refractive error, which leads to blurred vision, requiring glasses or contact lenses.

RxSight’s system is designed to make small adjustments to the power of the artificial implanted lens after surgery to enable better vision without glasses.

FDA Centre for Devices and Radiological Health Ophthalmic, and Ear, Nose and Throat division director Malvina Eydelman said: “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.”

“75% of the patients achieved a decrease in astigmatism six months after surgery.”

The new intraocular lens (IOL) uses a material that reacts to UV light delivered by the Light Delivery Device 17-21 days following surgery.

Patients are given three or four light treatments of approximately 40-150 seconds, based on the adjustment required, over a period of one to two weeks.

FDA has approved the device system based on the safety and effectiveness data obtained from a clinical study in 600 patients.

It was observed that six months following the procedure, subjects experienced an average improvement of around one additional line down the chart for distance vision without glasses, compared to a standard IOL.

The results further revealed that 75% of the patients achieved a decrease in astigmatism six months after surgery.