Latest News FDA Approves Raindrop Near Vision Inlay for Presbyopia Correction By Staff Friday, July 1, 2016 12:24 AM WASHINGTON, D.C.—The U.S. Food and Drug Administration has approved the Raindrop Near Vision Inlay, a device implanted in the cornea of one eye to improve near vision in certain patients with presbyopia. The inlay, manufactured by Revision Optics of Lake Forest, Calif., is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision.“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. “The Raindrop Near Vision Inlay provides a new option for surgical, outpatient treatment of presbyopia.”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 indicated for use in patients 41 to 65 years old who, in addition to not having had cataract surgery, are unable to focus clearly on near objects or small print and need reading glasses with +1.50 to +2.50 diopters of power—but do not need glasses or contacts for clear distance vision.To insert the device, an eye surgeon uses a laser to create a flap in the cornea of the patient’s non-dominant eye, implants the device into the opening, and puts the flap back in place. The inlay provides a steeper surface that can help the eye focus on near objects or print. The natural lens of the eye typically performs this function by changing shape, but in patients with presbyopia the lens becomes hardened and ineffective at focusing on close-up objects, which causes poor near vision. By reshaping the curvature of the cornea, the inlay corrects the refractive error that results in near vision problems.In April 2015, the Kamra inlay from Acufocus became the first corneal inlay to be approved by the FDA for use in vision correction surgery performed in the U.S.