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Dr. Q
Average Member
USA
27 Posts |
 Posted - 07 July 2003 : 23:53:40
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SANTA CLARA, Calif.--(BUSINESS WIRE)--May 23, 2003--VISX, INCORPORATED (NYSE:EYE - News) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for VISX CustomVue laser vision correction, a procedure that sets a new standard for vision correction, with the potential to enable better vision than contacts or glasses.
The CustomVue procedure tailors a unique correction for each individual. It employs the VISX WaveScan System, a new diagnostic system that captures a "fingerprint" of the eye which is 25 times more precise than what was previously measurable by standard methods. WaveScan evaluates more than nearsightedness, farsightedness, and astigmatism; it captures other, more specific imperfections in each individual's vision. This data is then used to generate an individualized treatment for a CustomVue procedure.
Dr. Robert Maloney, Director of the Maloney Vision Institute and Associate Clinical Professor of Ophthalmology, UCLA School of Medicine, participated in the VISX multi-center clinical study. Dr Maloney stated, "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."
The VISX clinical study results that were the basis of the Company's FDA approval exceeded all of the FDA required measurements for safe and effective laser vision correction. The FDA approval allows for WaveScan diagnosis and CustomVue treatment of patients with nearsightedness and astigmatism.
Clinical data presented at the American Society of Cataract and Refractive Surgery 2003 Symposium and Congress in San Francisco showed that at one year following the procedure, all of the follow-up examinations indicated that participants could pass a driving test to drive without glasses or contacts. 98% of the participants could see 20/20 or better and nearly 70% could see better than 20/20 without glasses or contacts. A six-month evaluation of clinical study participants showed that four times as many people were very satisfied with their night vision after the VISX CustomVue procedure, compared to their night vision before with glasses or contacts.
"Our goal is to continue to introduce new technologies that advance laser vision correction. We are very pleased to be the first on the U.S. market with approval of laser vision correction for both nearsightedness and astigmatism. We are now moving ahead with an FDA approved human clinical study for CustomVue procedures for the treatment of farsightedness," stated Liz Davila, chairman and chief executive officer of VISX.
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VISX CustomVue Receives FDA Approval
