Eyeworld

62 November 2016 by Lauren Lipuma EyeWorld Contributing Writer EW REFRACTIVE Long-awaited procedure expands refractive surgical options for myopes SMILE procedure earns FDA approval T his has been an incredible year for refractive cornea surgery. First was the approval of the iDesign advanced aberrometer/wavefront laser from Abbott Medical Optics, which was quickly followed by the Contoura topographic laser from Alcon. Now we have the latest and perhaps the greatest approval: the SMILE procedure using the VisuMax Femtosecond Laser from Carl Zeiss Meditec. The SMILE procedure represents a new category of refractive surgery that singularly employs a femto- second laser and has gained advocates from around the world for its small incision technology. I agree with Jon Dishler, MD, and Jim Mazzo that SMILE is additive to our re- fractive surgery armamentarium, and there appears to be good patient acceptance. However, the true judge of any surgical procedure will be safety and efficacy. Right now, the first trial performed in the United States was impressive with 88% of eyes achieving 20/20 or better vision. However, in comparison, the FDA trial for iDesign had 93.4% of patients achieving 20/20 and 79% 20/16. The Contoura FDA trial showed similar results with 92.7% of eyes achieving UCVA of 20/20 and 68.8% reaching 20/16 or better. Our goal as refractive surgeons should be to give patients as good if not better UCVA following refractive surgery as they had with their best pair of glasses preoperatively. We are well on our way. The initial results of SMILE are exciting, and as with all technology and experience, I expect them to improve over time. There will be challenges including the treatment of hyperopia and enhancements as well as the ability to treat topographic or wavefront abnormalities. However, for now, I could not be more delighted and have the feeling that the FDA gave us an early Christmas present this year. Eric Donnenfeld, MD, chief medical editor Refractive editor's corner of the world A refractive lenticule and small incision of less than 4 mm are created inside the intact cornea in one step. The lenticule is removed through the small incision with only minimal disruption to the corneal biomechanics. The removal of the lenticule changes the shape of the cornea, thereby achieving the desired refractive correction. Source: Carl Zeiss Meditec

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