Ansah Derick O, Wang Jiangxia, Lu Kevin, Jabbour Samir, Bower Kraig S, Soiberman Uri S
The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Department of Biostatistics, Johns Hopkins Biostatistics Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Ophthalmol Ther. 2020 Dec;9(4):1023-1040. doi: 10.1007/s40123-020-00306-1. Epub 2020 Oct 7.
The purpose of this non-comparative, prospective, observational study was to evaluate the post-US Food and Drug Administration approval outcomes of epithelium-off, full-fluence, Dresden protocol corneal collagen crosslinking (CXL) for the treatment of progressive keratoconus (KCN) and post-refractive corneal ectasia at a US academic tertiary medical center.
This study involved 125 eyes of 97 patients with KCN and 13 eyes of 12 patients with post-refractive ectasia which underwent CXL between November 2016 and September 2019. Best spectacle-corrected visual acuity (BSCVA) and corneal topographic parameters were measured preoperatively, at postoperative month 1 (POM-1), and between postoperative months 3 and 24 (POM 3-24).
Best spectacle-corrected visual acuity, flat keratometry, steep keratometry, and mean corneal power worsened at POM-1 (p < 0.01) with a return to preoperative values at POM 3-24. Maximum keratometry (Kmax) steepened at POM-1 and then improved beyond preoperative levels at POM 3-24 (p < 0.01 and p = 0.03, respectively). Pachymetry at the apex and pupil decreased at POM-1 and POM 3-24 (p = 0.03). Pachymetry at the thinnest point decreased at POM-1 and trended toward reduction at POM 3-24 (p < 0.001 and p = 0.06, respectively). Visual and tomographic outcomes were similar between pediatric and adult populations, and between KCN and post-refractive ectasia patients.
Real-world results of CXL in the USA are similar to those reported in prior studies, demonstrating an initial worsening of BSCVA, pachymetry, and keratometry followed by corneal flattening and preservation of visual acuity. Improvements in Kmax and stability in visual acuity were observed over 24 months in children and adults with progressive KCN or post-refractive ectasia.
这项非对比性、前瞻性观察性研究的目的是在美国一家学术性三级医疗中心评估美国食品药品监督管理局（FDA）批准后，采用上皮去除、全能量、德累斯顿方案角膜胶原交联（CXL）治疗进展性圆锥角膜（KCN）和屈光性角膜扩张后的效果。
本研究纳入了125只眼睛的97例KCN患者以及13只眼睛的12例屈光性角膜扩张患者，这些患者于2016年11月至2019年9月期间接受了CXL治疗。术前、术后第1个月（POM-1）以及术后第3至24个月（POM 3-24）测量最佳矫正视力（BSCVA）和角膜地形图参数。
最佳矫正视力、平坦角膜曲率、陡峭角膜曲率和平均角膜屈光力在POM-1时恶化（p < 0.01），在POM 3-24时恢复到术前值。最大角膜曲率（Kmax）在POM-1时变陡，然后在POM 3-24时改善至超过术前水平（分别为p < 0.01和p = 0.03）。角膜顶点和瞳孔处的角膜厚度在POM-1和POM 3-24时降低（p = 0.03）。最薄点处的角膜厚度在POM-1时降低，在POM 3-24时有降低趋势（分别为p < 0.001和p = 0.06）。儿童和成人人群之间以及KCN和屈光性角膜扩张患者之间的视觉和断层扫描结果相似。
美国CXL的实际应用结果与先前研究报告的结果相似，表明最初BSCVA、角膜厚度和角膜曲率会恶化，随后角膜变平并保持视力。在患有进展性KCN或屈光性角膜扩张的儿童和成人中，观察到Kmax在24个月内有所改善，视力保持稳定。
