Eyeworld

63 November 2016 EW REFRACTIVE was closely involved with the study from its planning stages through its completion. Approval of the SMILE pro- cedure is a major step forward in T he U.S. Food and Drug Administration (FDA) approved the small incision lenticule extraction (SMILE) procedure using the VisuMax Femtosecond Laser (Carl Zeiss Meditec, Jena, Germany) for the reduction of myopia in patients 22 years of age or older. The SMILE procedure is already available in more than 600 clinics in 61 countries worldwide. More than 600,000 SMILE procedures have been performed internationally since its introduction in 2011, ac- cording to a press release from Carl Zeiss Meditec. The procedure will be available to U.S. surgeons within the next few months, expanding the refractive options they can offer to patients. Approval of the procedure is a big win for Carl Zeiss Meditec as a company, for refractive surgeons, and for patients, said James Mazzo, global president, ophthalmic devices, Carl Zeiss Meditec. "I am thrilled that we have this new technology," Mr. Mazzo said in an interview with EyeWorld. "Any time you get approval of a major product in a major market is a win across any industry." Results The FDA announced approval of the procedure on September 13, slightly sooner than anticipated, Mr. Mazzo said. Results of the clinical study submitted to the FDA showed SMILE patients achieved excellent visual acuity, and refractive results were predictable for the 336 eyes treated at the five investigational sites across the country. Of the 328 participants evaluated at 6 months postop, all but one had uncorrected visual acu- ity of 20/40 or better, and 88% had uncorrected visual acuity of 20/20 or better. In addition to the excellent visual outcomes, participating sur- geons reported patients experienced a fast visual recovery with minimal discomfort. "I'm excited that it got FDA ap- proval, ahead of when was anticipat- ed, which I think speaks strongly for how strong the results were," said Jon Dishler, MD, founder of Dishler Laser Institute, Greenwood Village, Colorado. As both investigator and medical monitor in the clinical trial for the SMILE procedure, Dr. Dishler refractive surgery—equivalent to the approval of LASIK nearly 20 years ago, Dr. Dishler said. "Over time, [SMILE will] change the landscape of refractive surgery in the U.S., just like it has already in the rest of the world," he said. NOW IN SINGLE-USE ! by DIAMATRIX IRIS SPECULUM 6.7mm near-circular dilation 30 day trial available, call 800.867.8081 No Pinching, Easily Rotates Visit our website Diamatrix.com for additional information continued on page 64

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