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 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, non-randomized, multicenter, international post-market clinical follow-up study for the VisuMax 800 (Carl Zeiss Meditec). The 12-month follow-up was conducted retrospectively at a single center. Methods: Ninety eyes of 45 patients with myopia up to -10.00 D and astigmatism up to -3.00 D underwent KLEx. Postoperative exams 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 OSDI scores between 3 and 12 months were not statistically significant (p > 0.05), 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.