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FDA OKs First Implant to Reshape Cornea

The Raindrop Near Vision Inlay improves near vision by changing the shape of the cornea.

Published: June 30, 2016

RESHAPE THE CORNEA The inlay is placed under a laser corneal flap in the patient's non-dominant eye.

Eye surgeons can now use a corneal implant to improve the near vision of select presbyopes who've yet to undergo cataract surgery and would rather not wear glasses. The Raindrop Near Vision Inlay, which the FDA approved yesterday, is made of a hydrogel material that looks like a contact lens that could fit inside the eye of a needle.

Surgeons implant the Raindrop in the cornea of the patient's nondominant eye through a femtosecond-cut flap. The device, manufactured by ReVision Optics, reshapes the anterior curvature of the cornea to correct refraction in presbyopes, says the FDA.

"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," says 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 is intended for patients 41 to 65 years old who need reading glasses with +1.50 to +2.50 diopters of power, but don't need correction for clear distance vision. It's not recommended for patients with severe dry eye, active or recent eye infections, corneal disease, abnormal cornea anatomy, thin corneas, glaucoma and diabetes.

Two-year clinical data show 92% of patients who received the inlay had 20/40 vision. In addition, patient satisfaction with their presbyopia correction increased from 66% before the procedure to 87% post-op. More than 90% of patients experienced little to no glare or halos, and the inlay had no discernable impact on night vision.

ReVision Optics has also initiated a trial to assess the efficacy of combining Raindrop with monofocal, toric or accommodating IOLs. The results of the pilot study are similar to the visual improvement outcomes achieved with use of the Raindrop alone, says the company.

Last April, the FDA approved another corneal implant that corrects presbyopia, the KAMRA Inlay manufactured by AcuFocus. Rather than reshape the cornea, the opaque, ring-shaped device blocks peripheral light rays while letting central light rays pass through a small opening in the center of the device, making near objects and small print less blurry.

Daniel Cook


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