One-Year Clinical Outcomes Following a High-Volume Series of Small Incision Lenticule Extraction (SMILE) Procedures

Purpose: To assess the 12-month performance and safety outcomes of small incision lenticule extraction (SMILE) procedures performed on 193 eyes in a single day. Design: Retrospective, investigator-initiated, and single-centre study. Methods: All SMILE procedures were performed using the VisuMax 500 femtosecond laser (Carl Zeiss Meditec, Jena, Germany). Participants included all subjects eligible for the SMILE procedure who underwent surgery on 13 October 2021. Ocular measurements included uncorrected distance visual acuity (UDVA), refractive cylinder, and spherical equivalent refraction (SER). Measurements were obtained at baseline and at 1, 3, 6, and 12 months postoperatively. Results: The VisuMax 500 device was used intermittently from 7:15 AM to 11:30 PM, with a cumulative operating time of 12 hours and 15 min. A total of 193 SMILE procedures were successfully completed, while three eyes experienced suction loss and were excluded from analysis. Mean age ± SD was 26.93 ± 4.04 years, and 57.14% (56/98) of participants were female. Overall, 97.92% of eyes achieved UDVA of 20/20 or better at 12 months. No postoperative adverse events were reported. Conclusion: This study demonstrates that high-volume SMILE surgery can be performed safely and effectively in this single-centre setting using the VisuMax 500 platform, with excellent visual outcomes, high refractive predictability, and no significant postoperative complications at 12 months.