Keratorefractive lenticule extraction for myopia and myopic astigmatism using a 2 MHz femtosecond laser: 12-month refractive outcomes.

PURPOSE: To report refractive changes between 3 months and 12 months after keratorefractive lenticule extraction (KLEx) using the VisuMax 800 femtosecond laser in a retrospective monocenter study.

SETTING

University Hospital Gießen and Marburg, Department of Ophthalmology, Philipps University of Marburg, Germany.

DESIGN

The 3-month data were collected as part of a prospective, nonrandomized, multicenter, international postmarket clinical follow-up study for the VisuMax 800. The 12-month follow-up was conducted retrospectively at a single center.

METHODS

90 eyes of 45 patients with myopia up to -10.00 diopters (D) and astigmatism up to -3.00 D underwent KLEx. Postoperative examinations were performed at 3 and 12 months.

RESULTS

At 12 months, 36 patients (80%) completed follow-up. Mean preoperative spherical equivalent (SEQ) was -4.08 ± 2.04 D. Preoperative corrected distance visual acuity (CDVA) was ≥20/20 in 97% of eyes. At 3 months, uncorrected distance visual acuity (UDVA) was ≥20/20 in 89% and ≥20/25 in 99%. SEQ accuracy was within ±0.50 D in 94% and ±1.00 D in 100% of eyes (mean SEQ: 0.11 D). At 12 months, UDVA remained ≥20/20 in 89%, and SEQ accuracy within ±0.50 D in 96% (mean SEQ: 0.06 D). No significant CDVA loss was observed. Minor variations in astigmatism, satisfaction, and ocular surface disease index scores between 3 months and 12 months were not statistically significant ( P > .05), confirming overall refractive and subjective stability.

CONCLUSIONS

KLEx with the VisuMax 800 yields excellent and stable visual and refractive outcomes with high patient satisfaction and spectacle independence for myopia and myopic astigmatism.