Saad Amr, Steinberg Johannes, Frings Andreas
Department of Ophthalmology, Medical Faculty, University Hospital Düsseldorf, Heinrich Heine University, Moorenstraße 5, 40225, Dusseldorf, Germany.
Department of Ophthalmology, Stadtspital Zurich, Zurich, Switzerland.
Sci Rep. 2025 Jan 6;15(1):961. doi: 10.1038/s41598-024-83757-x.
To assess the efficacy, safety, and stability of refractive outcomes in hyperopic Laser-Assisted in Situ Keratomileusis (LASIK) with and without the application of Mitomycin C (MMC). This randomized, parallel group, controlled multicenter trial included 140 hyperopic eyes. The participants were randomly assigned to two groups: one receiving LASIK with mitomycin C (MMC) (n = 70) and the other receiving LASIK without MMC (n = 70). The primary outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and safety parameters at six months postoperatively. The statistical analysis employed t-tests, Mann-Whitney tests, and Fisher's Exact Test, with a significance level of p < 0.05. All 140 eyes (70 per group) were analyzed. No statistically significant differences were identified between the two groups in postoperative UDVA, CDVA, or safety parameters (p > 0.05). Both groups demonstrated highly effective and safe refractive outcomes. No intraoperative complications or postoperative adverse events were observed. Age and preoperative spherical equivalent did not significantly affect outcomes. Hyperopic LASIK with and without MMC showed comparable efficacy, safety, and stability of refractive outcomes at the six-month postoperative interval. Although MMC use in hyperopic LASIK appears to be a safe procedure, it was not found to be significantly superior to conventional LASIK. Further investigation with longer follow-up periods and larger cohorts is necessary to confirm these results.
评估应用与不应用丝裂霉素C（MMC）的远视性准分子原位角膜磨镶术（LASIK）屈光结果的有效性、安全性和稳定性。这项随机、平行组、对照多中心试验纳入了140只远视眼。参与者被随机分为两组：一组接受含丝裂霉素C（MMC）的LASIK手术（n = 70），另一组接受不含MMC的LASIK手术（n = 70）。主要观察指标为术后6个月时的裸眼远视力（UDVA）、矫正远视力（CDVA）和安全参数。统计分析采用t检验、曼-惠特尼检验和费舍尔精确检验，显著性水平为p < 0.05。对全部140只眼（每组70只）进行了分析。两组在术后UDVA、CDVA或安全参数方面未发现统计学显著差异（p > 0.05）。两组均显示出高效且安全的屈光结果。未观察到术中并发症或术后不良事件。年龄和术前等效球镜度数对结果无显著影响。应用与不应用MMC的远视性LASIK在术后6个月时屈光结果的有效性、安全性和稳定性相当。尽管在远视性LASIK中使用MMC似乎是一种安全的手术方法，但未发现其明显优于传统LASIK。需要进行更长随访期和更大样本量的进一步研究以证实这些结果。
