This article is more than 5 years old. Information may no longer be current.
Conductive keratoplasty using ViewPoint CK system is safe, highly effective, study says
Click Here to Manage Email Alerts
Today's Top Story and Breaking News feature highlights from yesterday's American Academy of Opthalmology presentations.
NEW ORLEANS — Conductive keratoplasty using Refractec’s ViewPoint CK system is comparable in efficacy to hyperopic LASIK, according to U.S. phase 3 trials of the device. Refractive stability has been demonstrated at 6 months and is maintained at 12 months, according to a presentation here at the American Academy of Ophthalmology meeting.
The CK procedure is safe, said clinical investigator Marguerite B. McDonald, MD, during a Breakfast with the Experts session here. Patient benefits include sparing of the visual axis, a large effective optical zone and no induced dry eye. Multicenter U.S. clinical trials will continue until all patients have 2-year follow-up, she said.
Data from the trial will be presented to the Food and Drug Administration on November 30. Dr. McDonald said she believes the technology and procedure will go through the approval process easily.
The safety results are excellent, according to Dr. McDonald. Seven of 355 patients lost two lines of best-corrected visual acuity, and no eyes were worse than 20/25 best corrected. No patients who were 20/20 or better best corrected preoperatively regressed to 20/25 or worse.