The FDA today approved a new form of laser vision correction called SMILE (Small Incision Lenticular Extraction) using the Zeiss Meditec femtosecond laser. SMILE was approved to treat only nearsightedness (myopia) and is approved for adults aged 22 years or older. It is not approved to treat farsightedness or astigmatism. In the FDA clinical trials that led to the approval of SMILE, 328 patients were followed for 6 months following surgery. All patients but 1 had vision of 20/40 or better (vision good enough to pass a driver’s test in California) and 88% had vision of 20/20 or better without glasses. SMILE joins LASIK and PRK as options for laser vision correction. Like LASIK and PRK, SMILE works by reshaping the cornea, but uses a slightly different approach. LASIK involves creating a surface flap and applying the laser under the flap and then re-positioning it. PRK works by applying the laser directly to the surface of the eye. SMILE works by applying a different type of laser within the cornea to separate a small disc of tissue. A small incision is made on the side of the cornea with the laser and the disc is removed by the surgeon, causing the cornea to change its shape. While the FDA data for SMILE is impressive, it is not as good at this point as the data for the latest versions of Customized Wavefront LASIK or Customized Wavefront PRK.  One of the possible advantages that SMILE has over LASIK (but not necessarily PRK) is that it may have less bio-mechanical impact on the tissue. There are still some technical downsides of SMILE, however, including questions about how to best do touch-up surgeries if necessary. SMILE has a much more limited range of treatment at this point than LASIK or PRK in that it can only treat nearsightedness whereas LASIK and PRK can treat nearsightedness, farsightedness, and astigmatism. Another disadvantage of SMILE is that it cannot yet correct vision with wavefront-guided treatments which allow more precision than non-wavefront treatments. Although SMILE is now approved in the United States, my opinion is that the procedure is still in a relatively early stage of its evolution, but is quite promising. I personally do not think SMILE will replace LASIK and PRK, but it likely will find niche uses where it has an important role.