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.