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ViewPoint CK System begins U.S. phase 3 trial

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IRVINE, Calif. — The Food and Drug Administration has approved initiating a phase 3 trial for Refractec's ViewPoint CK System for the treatment of presbyopia. ViewPoint harnesses radio frequency (RF) energy in a procedure Refractec calls conductive keratoplasty (CK). The device uses the RF energy to shrink collagen tissue within the cornea, thus reshaping it.

The ViewPoint CK System is already approved in some other countries. In the United States, the FDA has accepted Refractec's final module of its pre-market approval for the treatment of hyperopia.

Dan Durrie, MD, notes that after age 50, 100% of people need corrective lenses for presbyopia. "Based upon my previous experience with CK, these patients should be able to read newspaper print immediately after the procedure," he said. Dr. Durrie is a clinical investigator in the FDA trials of the ViewPoint.