Initial Single-Site Surgical Experience with SMILE: A Comparison of Results to FDA SMILE, and the Earliest and Latest Generation of LASIK.

INTRODUCTION

The primary objective was to show our initial surgical single-site experience with small incision lenticule extraction (SMILE) after the official enrollment in March 2017 following Food and Drug Administration (FDA) approval for simple myopia in late 2016 in the United States and, subsequently, compare our results to the earliest and most advanced generation of excimer platforms for laser-assisted in situ keratomileusis (LASIK) surgery.

METHODS

This was a retrospective single-site study of 68 eyes from 35 patients who had SMILE surgery. The patients' preoperative and postoperative uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest sphere, manifest cylinder, intraoperative complications, and preoperative and postoperative visual symptoms were collected. We compared our findings to the results from the FDA SMILE study, and to the three earliest (1999-2000) and three of the most updated (2013-2016) platforms for LASIK.

RESULTS

The cumulative UDVA was 20/20 and 20/40 or better in 74% and 100% of patients, respectively. The intended target refraction was within ± 0.5 and ± 1.00 D in 80% and 93% of cases, respectively. The prevalence of dry eyes decreased by nearly half from 1-week to the 6-month postoperative interval. Patients noted improvement in glare (17%), halos (17%), fluctuation (25%), and depth perception (8%) at the 6-month interval compared to preoperative levels.

CONCLUSIONS

This study's findings are consistent with current SMILE reports. Notably, the results are superior to the earliest generation of LASIK, however inferior to the latest excimer platforms. SMILE does meet the efficacy and safety criteria met by FDA; however, there is a definite need for further improvement to reach the superior refractive outcomes produced by the latest generation of LASIK platforms.