One-Year Visual Outcomes and Corneal Higher-Order Aberration Assessment of Small-Incision Lenticule Extraction for the Treatment of Myopia and Myopic Astigmatism

Abstract

We present a retrospective, single-center report of one-year visual outcomes for Small Incision Lenticule Extraction (SMILE) to treat myopia and myopic astigmatism, as well as to compare outcomes with other published literature, including results from the United States Food and Drug Administration (US FDA). A total of 405 eyes with a mean preoperative spherical equivalent of −5.54 diopters (D) underwent SMILE between April 2017 and April 2022. The outcomes measured included visual acuity, manifest refraction, vector analysis, and wavefront aberrometry at various time points, specifically pre-operative and twelve months post-operatively. Results were compared to other similar published studies of SMILE outcomes between 2012 and 2021. A total of 308 and 213 eyes were evaluated at three and twelve months, respectively. At twelve months, 79% of eyes achieved UDVA ≥ 20/20, and 99% had ≥20/40, with no patients losing ≥2 lines of vision. For accuracy, 84% of eyes were within 0.5 D of target SEQ, and 97% were within 1 D. Total corneal higher order aberrations (HOA) increased from 0.33 to 0.61 um. Significant change was found in vertical coma and spherical aberration at twelve months. SMILE remains a safe and effective treatment for myopia and myopic astigmatism. Clinical outcomes are likely to improve with increased surgeon experience and refinement of technology and nomograms.