Hashemi Hassan, Miraftab Mohammad, Seyedian Mohammad Amin, Hafezi Farhad, Bahrmandy Hooman, Heidarian Shahab, Amanzadeh Kazem, Nikbin Hamidreza, Fotouhi Akbar, Asgari Soheila
Noor Ophthalmology Research Center, Noor Eye Hospital, Tehran, Iran.
Center for Applied Biotechnology and Molecular Medicine (CABMM), University of Zurich, Zurich, Switzerland; Medical Faculty, University of Geneva, Geneva, Switzerland; Eye Care & Laboratory Research - Zurich Associates, Zurich, Switzerland; Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, California.
Am J Ophthalmol. 2015 Dec;160(6):1164-1170.e1. doi: 10.1016/j.ajo.2015.08.027. Epub 2015 Aug 24.
To compare the long-term outcomes of accelerated and standard corneal cross-linking protocols in the treatment of progressive keratoconus.
Prospective randomized clinical trial.
Thirty-one eyes with keratoconus were treated with an accelerated protocol (18 mW/cm(2), 5 min) and all contralateral eyes were treated with the standard method (3 mW/cm(2), 30 min) using the same overall fluence of 5.4 J/cm(2).
At 18 months after the procedure, the standard group showed significant improvement in spherical equivalent (P < .05), K-readings (P < .05), Q value (P < .05), index of surface variance (P < .05), and keratoconus index (P = .008) and decline in central corneal thickness (P < .05), but no significant change in visual acuity, corneal hysteresis, corneal resistance factor, P2 area, or endothelial cell density. In the accelerated group, central corneal thickness was the only parameter with statistically significant change. However, neither of these parameters showed significant differences between the standard and the 18 mW/cm(2) accelerated protocol, except K-reading (P = .059) and index surface variance (P = .034).
An accelerated cross-linking protocol, using 18 mW/cm(2) for 5 minutes, shows a comparable outcome and safety profile when compared to the standard protocol, but better corneal flattening is achieved with the standard method than the accelerated method. Overall, both methods stop the disease progression similarly. This study will continue to examine more long-term results.
比较加速角膜交联方案与标准角膜交联方案治疗进行性圆锥角膜的长期疗效。
前瞻性随机临床试验。
对31例圆锥角膜患者的患眼采用加速方案(18 mW/cm²,5分钟)进行治疗,对侧眼采用标准方法(3 mW/cm²,30分钟)进行治疗,两种方案的总辐照量均为5.4 J/cm²。
术后18个月,标准组的等效球镜度(P <.05)、K值(P <.05)、Q值(P <.05)、表面变异指数(P <.05)和圆锥角膜指数(P =.008)有显著改善,中央角膜厚度下降(P <.05),但视力、角膜滞后、角膜阻力因子、P2面积或内皮细胞密度无显著变化。在加速组中,中央角膜厚度是唯一有统计学显著变化的参数。然而,除K值(P =.059)和表面变异指数(P =.034)外,这些参数在标准组和18 mW/cm²加速方案之间均无显著差异。
与标准方案相比,采用18 mW/cm²照射5分钟的加速交联方案显示出相当的疗效和安全性,但标准方法比加速方法能更好地实现角膜平坦化。总体而言,两种方法在阻止疾病进展方面效果相似。本研究将继续观察更多长期结果。