Kandel Himal, Nguyen Vuong, Ferdi Alex C, Gupta Aanchal, Abbondanza Marco, Sullivan Laurence, Apel Andrew, Watson Stephanie L
The University of Sydney, Faculty of Medicine and Health, Save Sight Institute, Sydney, NSW, Australia.
Adelaide Eye & Laser Centre, Adelaide, SA, Australia.
Cornea. 2021 Dec 1;40(12):1581-1589. doi: 10.1097/ICO.0000000000002747.
The aim of this study was to compare the efficacy and safety of standard [Ultraviolet (UV) light power: 3 mW/cm2, duration: 30 minutes] versus accelerated (UV power: 9 mW/cm2, duration: 10 minutes) corneal crosslinking (CXL) for stabilizing keratoconus.
A total of 684 eyes (555 patients; mean age ± SD, 25.0 ± 7.9 years; women, 30.6%) from 24 international sites with epithelium-off CXL for keratoconus had follow-up data at 1-year and met the inclusion criteria. Two hundred sixty-six eyes (228 patients) had undergone standard CXL, and 418 eyes (327 patients) had undergone accelerated CXL. The outcome measures included changes in visual acuity, keratometry, minimum corneal thickness, and frequency of adverse events. The outcomes were compared using mixed-effects regression models adjusted for age, sex, visual acuity, keratometry, pachymetry, doctor, practice, and eye laterality.
The adjusted mean changes (95% confidence interval) in outcomes were similar in standard and accelerated CXL in visual acuity [6.5 (2.0, 11.1) versus 5.5 (0.4, 10.6) logMAR letters, respectively], Kmax [-0.9 (-1.4, -0.3) D versus -1.2 (-1.9, -0.4) D, respectively], K2 [-0.4 (-0.9, 0.2) D versus -0.4 (-1.1, 0.3), D respectively], or minimum corneal thickness [-13.3 (-20.3, -6.3) μm versus -16.6 (-24.5, -8.6) μm, respectively] (all P > 0.05). The frequency of adverse events at the 12-month visit was also similar between the CXL groups (standard, 8.3% vs. accelerated, 5.5%; P = 0.21).
This real-world observational study found that both standard and accelerated CXL were similarly safe and effective in stabilizing keratoconus at 1-year postsurgery in the real-world setting. The findings support the adoption of accelerated CXL for time and convenience.
本研究旨在比较标准（紫外线（UV）光功率：3 mW/cm²，持续时间：30分钟）与加速（UV功率：9 mW/cm²，持续时间：10分钟）角膜交联术（CXL）治疗圆锥角膜的疗效和安全性。
来自24个国际研究点的684只眼（555例患者；平均年龄±标准差，25.0±7.9岁；女性占30.6%）接受了去上皮CXL治疗圆锥角膜，并具有1年的随访数据且符合纳入标准。其中266只眼（228例患者）接受了标准CXL，418只眼（327例患者）接受了加速CXL。观察指标包括视力、角膜曲率、最小角膜厚度的变化以及不良事件的发生频率。采用混合效应回归模型对年龄、性别、视力、角膜曲率、角膜厚度、医生、医疗机构和眼别进行校正后比较结果。
标准CXL和加速CXL在视力（分别为6.5（2.0，11.1）与5.5（0.4，10.6）logMAR字母）、最大角膜曲率（分别为-0.9（-1.4，-0.3）D与-1.2（-1.9，-0.4）D）、第二角膜曲率（分别为-0.4（-0.9，0.2）D与-0.4（-1.1，0.3）D）或最小角膜厚度（分别为-13.3（-20.3，-6.3）μm与-16.6（-24.5，-8.6）μm）方面的校正后平均变化（95%置信区间）相似（所有P>0.05）。CXL组在12个月随访时不良事件的发生频率也相似（标准组为8.3%，加速组为5.5%；P = 0.21）。
这项真实世界观察性研究发现，在真实世界环境中，标准CXL和加速CXL在术后1年稳定圆锥角膜方面同样安全有效。这些发现支持采用加速CXL以节省时间和方便操作。
