Abstract：
OBJECTIVE: The aim of this study was to evaluate the 1-year outcomes of using processed amniotic fluid (pAF) postoperatively after photorefractive keratectomy (PRK).
METHODS: Sixty-one participants were randomized to receive either placebo or pAF drops. The drops were instilled 4 times daily for 1 week after PRK along with routine postoperative medications. The primary outcome measures included uncorrected visual acuity, topographic corneal irregularity measurement, and surface staining over 1 year.
RESULTS: A statistically significant difference in uncorrected distance visual acuity between the placebo and treatment groups was seen at 1 month post-PRK, with a visual advantage evident in the pAF group. A suggestive difference in corneal irregularity measurement was also seen between the placebo and treatment groups at 1 month postsurgery, with less irregularity noted in the pAF group. No differences in uncorrected distance visual acuity or corneal irregularity measurement were found at 3, 6, and 12 months. There was also no significant difference in corneal staining scores between the 2 groups at any of the measured time points.
CONCLUSIONS: This 1-year study evaluating the safety and efficacy of pAF as an additional postoperative topical medication after PRK demonstrated that pAF offered a mild visual advantage at 1 month post-PRK. There were no late adverse events, and the intervention proved safe at 1 year.
METHODS: Sixty-one participants were randomized to receive either placebo or pAF drops. The drops were instilled 4 times daily for 1 week after PRK along with routine postoperative medications. The primary outcome measures included uncorrected visual acuity, topographic corneal irregularity measurement, and surface staining over 1 year.
RESULTS: A statistically significant difference in uncorrected distance visual acuity between the placebo and treatment groups was seen at 1 month post-PRK, with a visual advantage evident in the pAF group. A suggestive difference in corneal irregularity measurement was also seen between the placebo and treatment groups at 1 month postsurgery, with less irregularity noted in the pAF group. No differences in uncorrected distance visual acuity or corneal irregularity measurement were found at 3, 6, and 12 months. There was also no significant difference in corneal staining scores between the 2 groups at any of the measured time points.
CONCLUSIONS: This 1-year study evaluating the safety and efficacy of pAF as an additional postoperative topical medication after PRK demonstrated that pAF offered a mild visual advantage at 1 month post-PRK. There were no late adverse events, and the intervention proved safe at 1 year.
摘要：
目的：本研究的目的是评估屈光性角膜切削术（PRK）术后使用羊水处理（pAF）的1年结局。
方法：61名参与者随机接受安慰剂或pAF滴剂。PRK后，每天滴注4次，持续1周，同时使用常规术后药物。主要结果指标包括未矫正视力，地形角膜不规则测量，和表面染色超过1年。
结果：在PRK后1个月，安慰剂组和治疗组之间的未矫正视力差异具有统计学意义，在pAF组中具有明显的视觉优势。在术后1个月时，安慰剂组和治疗组之间也观察到角膜不规则测量的暗示性差异，在pAF组中的不规则性较少。在3、6和12个月时，未矫正的远距视力或角膜不规则性测量均未发现差异。在任何测量的时间点，两组之间的角膜染色评分也没有显着差异。
结论：这项为期1年的研究评估了pAF作为PRK后额外的术后局部用药的安全性和有效性，表明pAF在PRK后1个月具有轻微的视觉优势。没有晚期不良事件，干预措施在1年时被证明是安全的。
方法：61名参与者随机接受安慰剂或pAF滴剂。PRK后，每天滴注4次，持续1周，同时使用常规术后药物。主要结果指标包括未矫正视力，地形角膜不规则测量，和表面染色超过1年。
结果：在PRK后1个月，安慰剂组和治疗组之间的未矫正视力差异具有统计学意义，在pAF组中具有明显的视觉优势。在术后1个月时，安慰剂组和治疗组之间也观察到角膜不规则测量的暗示性差异，在pAF组中的不规则性较少。在3、6和12个月时，未矫正的远距视力或角膜不规则性测量均未发现差异。在任何测量的时间点，两组之间的角膜染色评分也没有显着差异。
结论：这项为期1年的研究评估了pAF作为PRK后额外的术后局部用药的安全性和有效性，表明pAF在PRK后1个月具有轻微的视觉优势。没有晚期不良事件，干预措施在1年时被证明是安全的。
