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Abstract：
BACKGROUND: Corneal collagen cross-linking (CXL) is a procedure utilized for halting keratoconus progression with different approved protocols. The current study aimed to assess the corneal endothelial changes following the relatively new accelerated pulsed high-fluence protocol of epithelium-off corneal cross-linking for the treatment of mild to moderate keratoconus.
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).
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).
摘要：
背景：角膜胶原交联（CXL）是一种用于通过不同的批准方案停止圆锥角膜进展的程序。当前的研究旨在评估相对较新的上皮外角膜交联的加速脉冲高通量方案治疗轻度至中度圆锥角膜后的角膜内皮变化。
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）。
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）。
