Randomized controlled trial of corneal collagen cross-linking in progressive keratoconus: Preliminary results
Randomized controlled trial of corneal collagen cross-linking in progressive keratoconus: Preliminary results
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DOI：
10.3928/1081597x-20080901-15
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发表时间：
2008-09-01
影响因子：
2.4
通讯作者：
Snibson, Grant R.
中科院分区：
文献类型：
--
作者：
Wittig-Silva, Christine;Whiting, Mark;Snibson, Grant R.
目的：这项前瞻性、随机、对照试验旨在为角膜胶原交联剂(CXL)治疗进行性圆锥角膜的有效性和安全性提供证据。使用0.1%核黄素(在20%葡聚糖T500中)和紫外线(UVA)照射(370 nm，3 mW/cm(2)，30min)按照先前发表的方案进行胶原交联。在每一次回顾中，都进行了全面的临床眼科检查，包括内皮细胞计数和共聚焦显微镜。结果：到目前为止，已有49名有记录的圆锥角膜进展患者的66只眼被纳入并随机分组。治疗眼的中期分析显示，最陡的模拟角膜曲率测量值(K-max)在3个月时平均平坦0.74 D(P=0.004)，6个月时平均平坦0.92D(P=0.002)，12个月时平均平坦1.45D(P=0.002)。最佳矫正眼镜视力的改善趋势也被观察到。对照组3个月后平均K-max增加0.60 D(P=0.041)，6个月后增加0.60 D(P=0.013)，6个月后增加1.28 D(P=0.05)。
PURPOSE: This prospective, randomized, controlled trial aims to provide evidence in relation to the efficacy and safety of corneal collagen cross-linking (CXL) in the management of progressive keratoconus.METHODS: Eligible eyes were separately randomized into either treatment or control groups. Collagen cross-linking was performed using 0.1% riboflavin (in 20% dextran T500) and ultraviolet A (UVA) irradiation (370 nm, 3 mW/cm(2), 30 min) in accordance with a previously published protocol. At each review, a full clinical ophthalmic examination was performed including endothelial cell count and confocal microscopy.RESULTS: To date, 66 eyes of 49 patients with documented progression of keratoconus have been enrolled and randomized. Interim analysis of treated eyes showed a flattening of the steepest simulated keratometry value (K-max) by an average of 0.74 diopters (D) (P=.004) at 3 months, 0.92 D (P=.002) at 6 months, and 1.45 D (P=.002) at 12 months. A trend toward improvement in best spectacle-corrected visual acuity was also observed. In the control eyes, mean K-max steepened by 0.60 D (P=.041) after 3 months by 0 60 D (P=.013) after 6 months, and by 1.28 D (P