Visual and Refractive Outcomes of Small Incision Lenticule Extraction With VisuMax 800 in 1,500 Eyes.

Purpose: To assess visual and refractive outcomes of 1,500 eyes that underwent small incision lenticule extraction (SMILE) with the VisuMax 800 femtosecond laser (Carl Zeiss Meditec AG).

Methods: This retrospective study includes 1,500 eyes of 770 patients younger than 45 years with corrected distance visual acuity (CDVA) of 20/20 or better who were treated with SMILE using the VisuMax 800. The surgery was performed by an experienced surgeon using a standard technique and 3-month follow up data were analyzed.

Results: A total of 1,500 eyes of patients with a mean age of 27.25 ± 4.746 years (39.5% men and 60.52% women) were included in this study. At 3 months, 98% of eyes had uncorrected distance visual acuity (UDVA) of 20/20 or better with an efficacy index of 1.011. Mean preoperative spherical equivalent (SE) was -4.170 ± 1.860 and -0.025 ± 0.120 diopters (D) at 3 months (P < .001). A total of 18.4% gained one line of CDVA and 9.2% lost one line with a safety index of 1.085. Postoperative SE was within ±0.50 and ±1.00 D in 99% and 100% of eyes, respectively. A total of 98.4% and 100% of eyes showed astigmatism of 0.50 and 1.00 D or less, respectively. No eyes lost two or more lines of CDVA. At 3 months, the Objective Scatter Index score was 0.844 ± 0.486, which was close to preoperative values (0.733 ± 0.871), with a mean change of 0.11. Subgroup analysis was done based on grade of myopia and age.

Conclusion: The VisuMax 800, with centration guidance (CentraLign) and cyclotorsion adjustment features (OcuLign), showed safe and effective outcomes for the treatment of myopia and myopic astigmatism in a large cohort of 1,500 eyes.