Keratorefractive Lenticule Extraction for Myopia and Myopic Astigmatism With the VISUMAX 800: 6-Month Outcomes of a Prospective Multi-center Post-market Clinical Follow-up Study

Purpose To report the outcomes of small incision lenticule extraction (SMILE) using the VISUMAX 800 laser (Carl Zeiss Meditec) in a post-market clinical follow-up study. Methods This was a prospective, non-randomized, multi-center, international, post-market clinical follow-up study. The study took place from July 2021 to March 2023 at five sites across Europe and Asia. Patients meeting all inclusion criteria including myopia up to −10.00 diopters (D) and astigmatism up to 5.00 D were enrolled to undergo SMILE using the VISUMAX 800 femtosecond laser (Carl Zeiss Meditec). Patients were examined at 1 day, 1 week, and 1, 3, and 6 months after treatment. Results During the study period, 473 eyes (237 patients) were enrolled, treated, and analyzed. The preoperative spherical equivalent was −4.49 ± 1.87 D (range −0.25 to −10.00 D). Preoperative corrected distance visual acuity (CDVA) was 20/20 or better in 98.3% of eyes. At 6 months postoperatively, uncorrected distance visual acuity was 20/20 or better in 93.2% and 20/25 or better in 98.3% of eyes. Accuracy of spherical equivalent to intended target showed 95.1% of eyes were within ±0.50 D and 99.6% were within ±1.00 D for spherical equivalent and 90.8% of eyes were within ±0.50 D and 99.7% were within ±1.00 D for cylinder. There was a slight increase in monocular mesopic contrast sensitivity across all cycles per degree. There was one reported case of suction loss, which was not due to ocular movement. No eyes lost two or more lines of CDVA compared to baseline. Conclusions SMILE with the VISUMAX 800 provides excellent visual and refractive outcomes for patients with myopia and myopic astigmatism. [ J Refract Surg . 2025;41(3):e264–e271.]