To assess clinical results of the 9 mW/5.4 J/cm2 accelerated crosslinking (ACXL) in the treatment of progressive keratoconus (KC) over a span of 5 years. The prospective open non-randomized interventional study (Siena Eye-Cross Study 2) included 156 eyes of 112 patients with early progressive KC undergoing the Epi-Off 9 mW/5.4 J/cm2 ACXL at the Siena Crosslinking Centre, Italy. The mean age was 18.05 ± 5.6 years. The 20-min treatments were performed using the New KXL I (Avedro, Waltham, USA), 10 min of 0.1% HPMC Riboflavin soaking (VibeX Rapid, Avedro, Waltham, USA) and 10 min of continuous-light UV-A irradiation. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), Kmax, coma, minimum corneal thickness (MCT), surface asymmetry index (SAI), endothelial cell count (ECC) were measured, and corneal OCT performed. UDVA and CDVA improved significantly at the 3rd (P = 0.028), Δ + 0.17 Snellen lines and 6th postoperative month, respectively (P < 0.001), Δ + 0.23 Snellen lines. Kmax improved at the 6th postoperative month (P = 0.03), Δ − 1.49 diopters from the baseline value. Also, coma aberration value improved significantly (P = 0.004). A mild temporary haze was recorded in 14.77% of patients without affecting visual acuity and without persistent complications. Corneal OCT revealed a mean demarcation line depth at 332.6 ± 33.6 μm. The 5-year results of Epi-Off 9 mW/5.4 J/cm2 ACXL demonstrated statistically significant improvements in UCVA and CDVA, corneal curvature and corneal higher-order aberrations which confers a long-term stability for progressive ectasia. Based on the results of the Siena Eye-Cross Study 2, the 9 mW/5.4 J/cm2 ACXL is a candidate to be the natural evolution of Epi-Off CXL treatment for the management of early progressive corneal ectasia, and thus optimize clinic workflow.

中文翻译：

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早期进行性圆锥角膜加速9 mW角膜交联的长期结果：Siena交叉研究2

为了评估9 mW / 5.4 J / cm2加速交联（ACXL）在5年内进行性圆锥角膜（KC）的临床效果。这项前瞻性开放非随机干预研究（Siena交叉研究2）包括在意大利锡耶纳交联中心接受Epi-Off 9 mW / 5.4 J / cm2 ACXL的112例早期进行性KC患者的156眼。平均年龄为18.05±5.6岁。使用New KXL I（Avedro，沃尔瑟姆，美国），10％0.1％HPMC核黄素浸泡（VibeX Rapid，Avedro，沃尔瑟姆，美国）和10分钟连续光UV-A照射进行20分钟的处理。测量未矫正的远视力（UDVA），矫正的远视力（CDVA），Kmax，昏迷，最小角膜厚度（MCT），表面不对称指数（SAI），内皮细胞计数（ECC），并进行角膜OCT。UDVA和CDVA分别在第3天（P = 0.028），Δ+ 0.17 Snellen线和术后6个月显着改善（P <0.001），Δ+ 0.23 Snellen线。术后第6个月Kmax改善（P = 0.03），相对于基线值Δ− 1.49屈光度。同样，彗形像差值也显着提高（P = 0.004）。在14.77％的患者中记录到轻微的暂时性混浊，不影响视敏度，也没有持续的并发症。角膜OCT显示平均分界线深度为332.6±33.6μm。Epi-Off 9 mW / 5.4 J / cm2 ACXL的5年结果表明，UCVA和CDVA，角膜曲率和角膜高阶像差在统计学上有显着改善，这为进行性扩张期提供了长期稳定性。根据Siena交叉研究2的结果，其功率为9 mW / 5。