This article is more than 5 years old. Information may no longer be current.
CK for presbyopia receives U.S. marketing approval
Click Here to Manage Email Alerts
IRVINE, Calif. — The ViewPoint CK System received regulatory approval last week to perform conductive keratoplasty treatments for presbyopia, according to Refractec, the device’s marketer.
The presbyopia procedure, dubbed NearVision CK, is indicated for the temporary improvement of near vision in emmetropic presbyopes and hyperopic presbyopes, according to Refractec. The procedure is typically performed on just one eye, to provide monovision or blended-vision correction.
The approval is “the first and only [Food and Drug Administration]-approved vision technology that improves near vision,” in people with presbyopia, according to a Refractec news release. NearVision CK was designed specifically for people with presbyopia, Refractec noted.
The procedure was recommended for approval by the FDA’s Ophthalmic Devices Panel earlier this month.
The FDA approval was granted based on data from a 12-month postop follow-up on 150 eyes of 150 patients. These data have been previously reported in Ocular Surgery News.
According to Refractec, 98% could see J5 in the eye that was treated; 87% had a visual acuity of 20/20 in the distance and could also read J3. None of the patients reported serious, sight-threatening or unanticipated safety events.
According to the company, conductive keratoplasty has become the fastest-growing new refractive procedure since the introduction of LASIK.