The U.S. Food and Drug Administration has approved the Raindrop near vision inlay for implantation in the cornea to improve near vision in some patients with presbyopia, the agency announced in a press release.
The Raindrop inlay (ReVision Optics) is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery, and the first device to change the shape of the cornea to correct vision, the release said.
“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,” William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said. “The Raindrop near vision inlay provides a new option for surgical, outpatient treatment of presbyopia.”
In a clinical trial, near vision of 20/40 or better was achieved in 336 of 364 patients (92%) 2 years after implantation, the release said.
The Raindrop inlay is indicated for use in patients aged 41 to 65 years who have not had cataract surgery and are unable to focus clearly on near objects or small print and need reading glasses with +1.50 D to +2.50 D of power but do not need glasses or contact lenses for distance vision.
It is not recommended for patients with severe dry eye, active eye infection or inflammation, keratoconus, abnormal corneal features, certain autoimmune or connective tissue diseases, insufficient corneal thickness, recent herpes infection, uncontrolled glaucoma or uncontrolled diabetes.
Potential complications include glare, halos, foreign body sensation, infection, inflammation, dry eye, epithelial ingrowth and corneal scarring, swelling, thinning or melting.