Cornea and Laser Eye Institute- Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, New Jersey, and the Department of Ophthalmology, Rutgers Medical School, Newark, New Jersey.
Stulting Research Center, Woolfson Eye Institute, Atlanta, Georgia.
Ophthalmology. 2017 Sep;124(9):1259-1270. doi: 10.1016/j.ophtha.2017.03.052. Epub 2017 May 7.
To evaluate the safety and efficacy of corneal collagen crosslinking (CXL) for the treatment of progressive keratoconus.
Prospective, randomized, multicenter, controlled clinical trial.
Patients with progressive keratoconus (n = 205).
The treatment group underwent standard CXL and the sham control group received riboflavin alone without removal of the epithelium.
The primary efficacy criterion was the change over 1 year of topography-derived maximum keratometry value, comparing treatment with control group. Secondary outcomes evaluated were corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), manifest refraction spherical equivalent, endothelial cell count, and adverse events.
In the CXL treatment group, the maximum keratometry value decreased by 1.6 diopters (D) from baseline to 1 year, whereas keratoconus continued to progress in the control group. In the treatment group, the maximum keratometry value decreased by 2.0 D or more in 28 eyes (31.5%) and increased by 2.0 D or more in 5 eyes (5.6%). The CDVA improved by an average of 5.7 logarithm of the minimum angle of resolution (logMAR) units. Twenty-three eyes (27.7%) gained and 5 eyes lost (6.0%) 10 logMAR or more. The UDVA improved 4.4 logMAR. Corneal haze was the most frequently reported CXL-related adverse finding. There were no significant changes in endothelial cell count 1 year after treatment.
Corneal collagen crosslinking was effective in improving the maximum keratometry value, CDVA, and UCVA in eyes with progressive keratoconus 1 year after treatment, with an excellent safety profile. Corneal collagen crosslinking affords the keratoconic patient an important new option to decrease progression of this ectatic corneal process.
评估角膜胶原交联（CXL）治疗进行性圆锥角膜的安全性和有效性。
前瞻性、随机、多中心、对照临床试验。
进展性圆锥角膜患者（n = 205）。
治疗组行标准 CXL，假手术对照组仅给予核黄素，不去除上皮。
主要疗效标准为治疗组与对照组 1 年时基于地形图的最大角膜曲率值变化。次要观察指标为矫正视力（CDVA）、未矫正视力（UDVA）、角膜曲率等效球镜、内皮细胞计数和不良事件。
CXL 治疗组的最大角膜曲率值从基线到 1 年下降了 1.6 屈光度（D），而对照组的圆锥角膜仍在进展。在治疗组中，28 只眼（31.5%）最大角膜曲率值下降 2.0 D 或更多，5 只眼（5.6%）增加 2.0 D 或更多。CDVA 平均提高 5.7 个最小分辨角对数（logMAR）单位。23 只眼（27.7%）提高 10 logMAR 或更多，5 只眼（6.0%）下降 10 logMAR 或更多。UDVA 提高 4.4 logMAR。最常报告的 CXL 相关不良事件是角膜混浊。治疗 1 年后内皮细胞计数无明显变化。
CXL 治疗 1 年后可有效改善进行性圆锥角膜的最大角膜曲率值、CDVA 和 UCVA，安全性良好。CXL 为圆锥角膜患者提供了一种新的重要选择，可减缓这种扩张性角膜病变的进展。
