SANTA CLARA, Calif., May 28 -- VISX Inc. has received approval from the US Food and Drug Administration (FDA) for its CustomVue laser vision correction procedure. CustomVue uses VISX's WaveScan diagnostic system to evaluate patients for nearsightedness, farsightedness and astigmatism and other imperfections and to generate a treatment plan for a CustomVue procedure, VISX said.
The FDA approval allows for WaveScan diagnosis and CustomVue treatment of patients with nearsightedness and astigmatism.
Dr. Robert Maloney, director of the Maloney Vision Institute and Associate Clinical Professor of Ophthalmology, UCLA School of Medicine, participated in the VISX clinical study. He said, "The results from CustomVue procedures are very impressive, with potential for sharper vision and improved night vision over contacts and glasses. There is no question that this technology is a significant step forward in the advancement of laser vision correction."
Clinical data presented at the American Society of Cataract and Refractive Surgery 2003 Symposium and Congress showed that a year following the procedure, follow-up exams indicated participants could pass a test to drive without glasses or contacts. Ninety-eight percent of the participants could see 20/20 or better, and nearly 70 percent could see better than 20/20 without glasses or contacts, VISX said.
The company said it is now working on an FDA-approved human clinical study of CustomVue for the treatment of farsightedness.
For more information, visit: www.VISX.com