Comparative Validation of a VISULYZE‐Based Nomogram for Predicting Visual Outcomes and Higher‐Order Aberrations After SMILE in High Myopia

Purpose To validate a novel VISULYZE‐based nomogram for high myopia in small incision lenticule extraction (SMILE) surgery. Methods This prospective, nonrandomized controlled trial included 118 eyes of 71 high‐myopia patients treated with SMILE using a VisuMax 500‐kHz femtosecond laser. High myopia was defined as a spherical equivalent refraction ≤ −6.00 D. Treated eyes were divided into two groups, according to different nomograms received: the conventional surgeon‐adjusted nomogram group ( n = 71 eyes) and the VISULYZE‐based nomogram group ( n = 47 eyes). The VISULYZE nomogram was generated by the data from 108 myopic eyes that underwent SMILE surgery at 3 months. The visual outcomes followed up for 3 months for both groups were compared for efficacy, safety, predictability, stability, and higher‐order aberrations (HOAs). Results Preop‐SE was −6.58 ± 0.50 D in the conventional group and −6.79 ± 0.61 D in the VISULYZE group. At 3 months postoperatively, the SE in the conventional group and the VISULYZE group was −0.16 ± 0.34 D and 0.05 ± 0.40 D ( p < 0.05), respectively. It was found that 72% and 100% had a UDVA of 20/20 in the conventional group and VISULYZE group, respectively, while 89% and 99% had an SE within ±0.5 D and ±1.0 D in the conventional group and 89% and 100% in the VISULYZE group. The efficacy indexes were 0.97 ± 0.07 in the conventional group and 1.02 ± 0.06 in the VISULYZE group ( p < 0.05). The safety indexes were 1.15 ± 0.10 in the conventional group and 1.15 ± 0.15 in the VISULYZE group ( p > 0.05), respectively. The VISULYZE‐based nomogram was associated with lower induction of 3rd‐order vertical/horizontal coma, total coma, 4th‐order spherical aberration, and root mean square (RMS) HOAs. Conclusions The VISULYZE‐based nomogram demonstrated comparable safety to the conventional nomogram while achieving significantly superior efficacy and predictability. Additionally, it provided a supportive condition for reducing RMS HOAs after SMILE compared to the conventional approach. Trial Registration: ClinicalTrials.gov: NCT06982807