Near Vision Device Approved for Patients with Presbyopia

The FDA has approved the Raindrop Near Vision Inlay, which can be used to improve near vision in patients with presbyopia.

This product, which is directly implanted into the cornea of 1 eye, is the second FDA-approved implantable corneal device for individuals who have not had cataract surgery. It is the first implantable device that alters the shape of the cornea as the method for improving vision, the FDA noted in a press release.

The Raindrop Near Vision Inlay is composed of a hydrogel material and looks like a contact lens, but it is smaller than the eye of a needle. Surgeons implant the device by creating a flap in the cornea of the patient’s non-dominant eye, placing the product inside, and putting the flap back in place.

The inlay is designed for patients aged 41 to 65 years who cannot focus clearly on nearby objects or small print.

The safety and efficacy of the Raindrop Near Vision Inlay was examined in 373 subjects in a clinical trial. After 2 years, 92% of patients who received the device were able to see with 20/40 vision or better.

The inlay may cause or worsen problems with glare, halos, foreign body sensation, and pain. Infection, inflammation, dry eye, retinal detachment, and a decrease in distance vision may occur, as well as complications related to the cornea. Some patients may need to remove or replace the inlay.

Individuals with presbyopia lose the ability to change the focusing power of the eye. Almost everyone develops the condition with aging. The Raindrop Near Vision Inlay is an alternative to wearing bifocals or reading glasses.

“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, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, in a press release. “The Raindrop Near Vision Inlay provides a new option for surgical, outpatient treatment of presbyopia.”