METHODS: This prospective case series study enrolled 45 eyes of 27 patients with mild to moderate progressive keratoconus who underwent accelerated pulsed high-fluence CXL (pl-ACXL, 30 mW/ cm2 UVA at 365 nm wavelength, 8 min pulsed mode 1 s on / 1 s off with a total energy of 7.2 J/ cm2). The main outcome measures were corneal endothelial changes assessed by specular microscopy at 3 and 6 months postoperatively including endothelial cell density (ECD), coefficient of variation, percentage of hexagonal cells, average, minimum and maximum endothelial cell sizes. Demarcation line depth was assessed 1 month following surgery.
RESULTS: The mean age of the studied sample was 24.89 ± 7.21. The mean preoperative ECD (2944.6 ± 247.41 cell/mm2) showed non-significant reduction at 3 and 6 months postoperatively (2931.03 ± 253.82 and 2924.7 ± 224.88 cell/mm2, respectively, P-value = 0.361). There were no significant changes in the mean coefficient of variation, percentage of hexagonal cells, average, minimum and maximum endothelial cell sizes at 3 and 6 months following pl-ACXL (P-value > 0.05). The mean demarcation line depth 1 month after pl-ACXL was 214 ± 17.43 μm.
CONCLUSIONS: Corneal endothelial changes following accelerated pulsed high-fluence CXL were minimal with stability of endothelial cell count and non-significant morphological changes.
BACKGROUND: Clinicaltrials.gov: NCT04160338 (13/11/2019).
方法:这项前瞻性病例系列研究纳入了27例轻度至中度进行性圆锥角膜患者的45只眼睛,这些患者接受了加速脉冲高通量CXL(pl-ACXL,365nm波长下的30mW/cm2UVA,8分钟脉冲模式1s开/1s关,总能量为7.2J/cm2)。主要结果指标为术后3个月和6个月通过镜面反射显微镜评估的角膜内皮变化,包括内皮细胞密度(ECD),变异系数,六边形细胞的百分比,平均,最小和最大内皮细胞大小。手术后1个月评估分界线深度。
结果:研究样本的平均年龄为24.89±7.21。术前平均ECD(2944.6±247.41细胞/mm2)在术后3个月和6个月时无明显减少(分别为2931.03±253.82和2924.7±224.88细胞/mm2,P值=0.361)。平均变异系数没有显著变化,六边形细胞的百分比,平均,pl-ACXL后3个月和6个月的最小和最大内皮细胞大小(P值>0.05)。pl-ACXL后1个月的平均分界线深度为214±17.43μm。
结论:加速脉冲高通量CXL后角膜内皮变化最小,内皮细胞计数稳定,形态学变化不明显。
背景:临床试验:NCT04160338(2019年11月13日)。