FDA clears study on laser hyperopia treatment

17 Jun 2002

The United States Food and Drug Administration has given conditional approval to Sunrise Technologies International, Inc., to begin a study to expand the hyperopic treatment range using the sunrise LTK procedure to up to 4 diopters. Sunrise is currently in Phase III clinical trials in the range of 0.75 to 2.5 diopters, but studies performed outside the United States indicate possible correction of up to 4 diopters. The new study will begin on 20 patients with hyperopia (farsightedness) at two sites.