10-Year Results of Small Incision Lenticule Extraction

PURPOSE: To evaluate the 10-year results of refractive lenticule extraction using the small incision lenticule extraction (SMILE) technique for treatment of myopia and myopic astigmatism. METHODS: In 2008–2009, the first 91 eyes were treated using a novel surgical technique (SMILE), in which a refractive lenticule of intrastromal corneal tissue is removed through a small incision, completely eliminating flap cutting. A total of 56 of 91 eyes of the original treatment group volunteered for reexamination 10 years after surgery, including uncorrected and corrected distance visual acuity, objective and manifest refraction, and evaluation of the interface and corneal surface by slit-lamp examination. Late side effects such as corneal scarring, corneal ectasia, persistent dry eye symptoms, or cataract were documented. RESULTS: At 10 years postoperatively, there was no significant change from the 6-month results. Spherical equivalent was −0.35 ± 0.66 diopters and therefore close to target refraction. Sixteen of the 56 eyes (29%) had gained one to two Snellen lines. There was no loss of two or more lines in the long term. Regression was −0.35 ± 0.66 diopters over the 10-year period. CONCLUSIONS: This 10-year long-term study demonstrates SMILE to be an effective, stable, and safe procedure for the treatment of myopia and myopic astigmatism. [ J Refract Surg. 2019;35(10):618–623.]