From the Department of Ophthalmology (S.M.N.), School of Medicine, University of Colorado, Aurora, Colorado, USA.
and the Department of Ophthalmology (B.S.H., I.C.K.), Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Am J Ophthalmol. 2021 Sep;229:274-287. doi: 10.1016/j.ajo.2021.05.009. Epub 2021 May 25.
The purpose of this study was to summarize key findings from a systematic review of the effectiveness and safety of transepithelial corneal crosslinking (CXL) compared with epithelium-off CXL for progressive keratoconus.
Cochrane systematic review.
We included in our review only randomized controlled trials (RCTs) in which transepithelial and epithelium-off CXL had been compared among participants with progressive keratoconus. The primary outcome was keratoconus stabilization based on post-operative maximum keratometry (Kmax). We adhered to Cochrane methods for trial selection, data extraction, risk of bias evaluation, and data synthesis.
Thirteen RCTs with 567 participants (661 eyes) were included; 11 studies compared non-iontophoresis-assisted transepithelial with epithelium-off CXL. Keratoconus stabilization was described as an outcome in 2 studies. The estimated difference in Kmax means (ie, the "mean difference," MD) from meta-analysis of 177 eyes in 5 RCTs indicated that there were no differences between intervention groups in Kmax at 12 months or later (MD: 0.99 diopter [D]; 95% confidence interval: -0.11 to 2.09). Meta-analysis of keratometry and visual acuity outcomes at 12 months or longer after surgery from 2 studies that had compared transepithelial CXL using iontophoresis provided no conclusive evidence of an advantage over epithelium-off CXL.
Lack of precision due to small sample sizes, indeterminate risk of bias due to inadequate reporting, and inconsistency in how outcomes were measured and reported among studies make it difficult to state with confidence whether transepithelial CXL confers an advantage over epithelium-off CXL for patients with progressive keratoconus with respect to stabilization of keratoconus, visual acuity, or patient-reported outcomes based on available data.
本研究旨在总结系统评价中关于经上皮角膜交联(CXL)与去上皮 CXL 在进展性圆锥角膜中的有效性和安全性的关键发现。
Cochrane 系统评价。
我们仅纳入了比较进展性圆锥角膜患者中经上皮和去上皮 CXL 的随机对照试验(RCT)。主要结局是基于术后最大角膜曲率计(Kmax)的圆锥角膜稳定。我们坚持 Cochrane 方法进行试验选择、数据提取、偏倚风险评估和数据综合。
纳入了 13 项 RCT,共 567 名参与者(661 只眼);其中 11 项研究比较了非离子电渗经上皮与去上皮 CXL。2 项研究描述了圆锥角膜稳定作为结局。5 项 RCT 中 177 只眼的荟萃分析估计的 Kmax 均值差异(即“平均差异”,MD)表明,干预组在 12 个月或更长时间后 Kmax 没有差异(MD:0.99 屈光度[D];95%置信区间:-0.11 至 2.09)。2 项比较经上皮离子电渗 CXL 的研究在术后 12 个月或更长时间的角膜曲率和视力结局的荟萃分析没有提供明确证据表明经上皮 CXL 在圆锥角膜稳定、视力或患者报告结局方面优于去上皮 CXL。
由于样本量小导致精确度不足,由于报告不充分导致不确定的偏倚风险,以及研究之间如何测量和报告结局的不一致性,使得根据现有数据很难自信地确定经上皮 CXL 是否优于去上皮 CXL 在进展性圆锥角膜患者的圆锥角膜稳定、视力或患者报告结局方面具有优势。