{"title":"Comparative Validation of a VISULYZE-Based Nomogram for Predicting Visual Outcomes and Higher-Order Aberrations After SMILE in High Myopia.","authors":"Lingling Zhao, Nannan Gao, Enze Liu, Xinliang Cheng, Juehan Li, Haixia Ji, Ying Yu","doi":"10.1155/joph/1918446","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To validate a novel VISULYZE-based nomogram for high myopia in small incision lenticule extraction (SMILE) surgery.</p><p><strong>Methods: </strong>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 (<i>n</i> = 71 eyes) and the VISULYZE-based nomogram group (<i>n</i> = 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).</p><p><strong>Results: </strong>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 (<i>p</i> < 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 (<i>p</i> < 0.05). The safety indexes were 1.15 ± 0.10 in the conventional group and 1.15 ± 0.15 in the VISULYZE group (<i>p</i> > 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.</p><p><strong>Conclusions: </strong>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. <b>Trial Registration:</b> ClinicalTrials.gov: NCT06982807.</p>","PeriodicalId":16674,"journal":{"name":"Journal of Ophthalmology","volume":"2026 ","pages":"1918446"},"PeriodicalIF":2.2000,"publicationDate":"2026-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13277769/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Ophthalmology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1155/joph/1918446","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Journal of Ophthalmology is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies related to the anatomy, physiology and diseases of the eye. Submissions should focus on new diagnostic and surgical techniques, instrument and therapy updates, as well as clinical trials and research findings.
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