Implantable Device to Improve Near Vision in Patients with Presbyopia Approved by FDA

It is the first FDA-approved device that changes the shape of the cornea to achieve improved vision

Implantable Device to Improve Near Vision in Patients with Presbyopia Approved by FDA
June 30, 2016

The Food and Drug Administration (FDA) has issued an approval for a new device that treats farsightedness.

The agency's approval is for the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. This is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery. It is the first that changes the shape of the cornea to achieve improved vision.

The Raindrop Near Vision Inlay is a clear device made of a hydrogel material and resembles a tiny contact lens smaller than the eye of a needle. It is designed for use in patients 41 to 65 years old whoare unable to focus clearly on near objects or small print, but do not need glasses or contacts for clear distance vision.

Presbyopia is the loss of the ability to change the focusing power of the eye, resulting in diminished near vision. The focusing power of the eye decreases in nearly all adults over the course of their lifetime.

"Given the prevalence of presbyopia and the aging of the baby boomer population, the need for near vision correction will likely rise in the coming years," said William Maisel, in a written statement. Maisel is the deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health. "The Raindrop Near Vision Inlay provides a new option for surgical, outpatient treatment of presbyopia."

The safety and effectiveness of the Raindrop Near Vision Inlay were studied in a clinical trial of 373 subjects implanted with the device. Two years after implantation, 92 percent of patients included in the analysis were able to see with 20/40 vision or better at near distances with the inlay-implanted eye.

The Raindrop Near Vision Inlay implantation may cause or worsen problems with glare, halos, foreign body sensation, and pain. There is a risk of developing infection, inflammation, a new dry eye condition or exacerbation of an existing dry eye condition, retinal detachment, or a decrease in distance vision. If these conditions arise, patients may require a second surgery to remove or replace the inlay.

The Raindrop Near Vision Inlay is manufactured by Revision Optics, Inc.