Abstract：
BACKGROUND: Infectious keratitis is a major cause of global blindness. We tested whether standalone photoactivated chromophore corneal cross-linking (PACK-CXL) may be an effective first-line treatment in early to moderate infectious keratitis, compared with standard antimicrobial treatment.
METHODS: This is a randomized, controlled, multinational phase 3 clinical trial. Participants in five centers in Egypt, India, Iran, Israel, and China, aged ≥ 18 years, with infectious keratitis of presumed bacterial, fungal, or mixed origin, were randomly assigned (1:1) to PACK-CXL, or antimicrobial therapy. Outcomes measures included healing, defined as time to re-epithelialization of the corneal epithelial defect in the absence of inflammatory activity in the anterior chamber and clearance of stromal infiltrates. Treatment success was defined as the complete resolution of signs of infection.
RESULTS: Between July 21, 2016, and March 4, 2020, participants were randomly assigned to receive PACK-CXL (n = 18) or antimicrobial therapy per American Academy of Ophthalmology (AAO) guidelines (n = 21). No participants were lost to follow-up. Four eyes were excluded from the epithelialization time analysis due to treatment failure: two in the antimicrobial therapy group, and two in the PACK-CXL group. Success rates were 88.9% (16/18 patients) in the PACK-CXL group and 90.5% (19/21 patients) in the medication group. There was no significant difference in time to complete corneal re-epithelialization (P = 0.828) between both treatment groups.
CONCLUSIONS: PACK-CXL may be an alternative to antimicrobial drugs for first-line and standalone treatment of early to moderate infectious keratitis of bacterial or fungal origin. Trial registration This trial is registered at ClinicalTrials.gov, trial registration number: NCT02717871.
METHODS: This is a randomized, controlled, multinational phase 3 clinical trial. Participants in five centers in Egypt, India, Iran, Israel, and China, aged ≥ 18 years, with infectious keratitis of presumed bacterial, fungal, or mixed origin, were randomly assigned (1:1) to PACK-CXL, or antimicrobial therapy. Outcomes measures included healing, defined as time to re-epithelialization of the corneal epithelial defect in the absence of inflammatory activity in the anterior chamber and clearance of stromal infiltrates. Treatment success was defined as the complete resolution of signs of infection.
RESULTS: Between July 21, 2016, and March 4, 2020, participants were randomly assigned to receive PACK-CXL (n = 18) or antimicrobial therapy per American Academy of Ophthalmology (AAO) guidelines (n = 21). No participants were lost to follow-up. Four eyes were excluded from the epithelialization time analysis due to treatment failure: two in the antimicrobial therapy group, and two in the PACK-CXL group. Success rates were 88.9% (16/18 patients) in the PACK-CXL group and 90.5% (19/21 patients) in the medication group. There was no significant difference in time to complete corneal re-epithelialization (P = 0.828) between both treatment groups.
CONCLUSIONS: PACK-CXL may be an alternative to antimicrobial drugs for first-line and standalone treatment of early to moderate infectious keratitis of bacterial or fungal origin. Trial registration This trial is registered at ClinicalTrials.gov, trial registration number: NCT02717871.
摘要：
背景：感染性角膜炎是全球失明的主要原因。我们测试了独立的光活化发色团角膜交联（PACK-CXL）是否可能是早期至中度感染性角膜炎的有效一线治疗方法。与标准抗菌治疗相比。
方法：这是一个随机的，控制,跨国3期临床试验。埃及五个中心的参与者，印度,伊朗,以色列,和中国,年龄≥18岁，假定细菌的感染性角膜炎，真菌,或混合起源，被随机分配(1:1)到PACK-CXL，或者抗菌治疗.结果措施包括治疗，定义为在前房中没有炎症活动和基质浸润清除的情况下角膜上皮缺损再上皮化的时间。治疗成功被定义为感染迹象的完全解决。
结果：在2016年7月21日至2020年3月4日之间，根据美国眼科学会（AAO）指南（n=21），参与者被随机分配接受PACK-CXL（n=18）或抗菌治疗。没有参与者失去随访。由于治疗失败，4只眼被排除在上皮形成时间分析之外：抗菌治疗组2只眼，和两个在PACK-CXL组中。PACK-CXL组成功率为88.9%（16/18例），药物组为90.5%（19/21例）。两个治疗组之间完成角膜上皮再形成的时间没有显着差异（P=0.828）。
结论：PACK-CXL可能是抗菌药物的替代药物，用于细菌或真菌来源的早期至中度感染性角膜炎的一线和独立治疗。试验注册本试验在ClinicalTrials.gov注册，试验注册号：NCT02717871。
方法：这是一个随机的，控制,跨国3期临床试验。埃及五个中心的参与者，印度,伊朗,以色列,和中国,年龄≥18岁，假定细菌的感染性角膜炎，真菌,或混合起源，被随机分配(1:1)到PACK-CXL，或者抗菌治疗.结果措施包括治疗，定义为在前房中没有炎症活动和基质浸润清除的情况下角膜上皮缺损再上皮化的时间。治疗成功被定义为感染迹象的完全解决。
结果：在2016年7月21日至2020年3月4日之间，根据美国眼科学会（AAO）指南（n=21），参与者被随机分配接受PACK-CXL（n=18）或抗菌治疗。没有参与者失去随访。由于治疗失败，4只眼被排除在上皮形成时间分析之外：抗菌治疗组2只眼，和两个在PACK-CXL组中。PACK-CXL组成功率为88.9%（16/18例），药物组为90.5%（19/21例）。两个治疗组之间完成角膜上皮再形成的时间没有显着差异（P=0.828）。
结论：PACK-CXL可能是抗菌药物的替代药物，用于细菌或真菌来源的早期至中度感染性角膜炎的一线和独立治疗。试验注册本试验在ClinicalTrials.gov注册，试验注册号：NCT02717871。
