Village-integrated eye workers for prevention of corneal ulcers in Nepal (VIEW study): a cluster-randomised controlled trial.
Village-integrated eye workers for prevention of corneal ulcers in Nepal (VIEW study): a cluster-randomised controlled trial.
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DOI：
10.1016/s2214-109x(21)00596-9
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发表时间：
2022-04
影响因子：
34.3
通讯作者：
Keenan, Jeremy D.
中科院分区：
文献类型：
--
作者：
O'Brien, Kieran S.;Byanju, Raghunandan;Kandel, Ram P.;Poudyal, Bimal;Gonzales, John A.;Porco, Travis C.;Whitcher, John P.;Srinivasan, Muthiah;Upadhyay, Madan;Lietman, Thomas M.;Keenan, Jeremy D.
在低收入和中等收入国家，角膜溃疡是导致失明的常见原因，通常是由农业工作中的创伤性角膜擦伤引起的。角膜擦伤的抗菌预防可能有助于预防角膜溃疡，但治疗开始的延迟是经常发生的。尼泊尔进行了一项整群随机试验，以确定以社区为基础的角膜溃疡预防计划(Clinicaltrials.gov#NCT01969786)的有效性。随机单位是乡村发展委员会(VDC)。研究区域内有15,000人的VDC有资格被纳入。在干预组中，预先存在的女性社区卫生志愿者(FCHV)接受了诊断角膜擦伤的培训，并提供了为期三天的眼科抗菌药疗程。主要结果是意外的角膜溃疡，通过对角膜照片的遮盖评估来确定。在2014年2月4日至2017年10月20日期间，12名VDC随机接受干预，12名对照VDC不接受干预。213697人被包括在基线普查中。FCHV对4777例角膜擦伤进行了诊断并提供了抗菌剂。自行报告的药物过敏发生率为0.2%。普查发现干预组246,893人年发生角膜混浊289例，对照组239,170人年发生262例混浊(干预组发病率1.21，95%可信区间0.85~1.74/1000人年，对照组1.18，95%可信区间0.82~1.70)，意向治疗发生率比(IRR)1.03，95%可信区间0.63~1.67；P=0.93。探索性亚组分析表明，有效性可能取决于地理位置(例如，农村地区的IRR为0.50，95%CI为0.19-1.30；城市周边或城市地区的IRR为1.31，95%CI为0.86-1.99；亚组交互作用的P=0.04)。这项试验未能检测到社区角膜溃疡预防计划的前三年角膜溃疡发生率的减少。在更多没有基本眼科护理设施的农村地区，可能需要进行进一步的研究。
Corneal ulcers are a common cause of blindness in low- and middle-income countries, usually resulting from traumatic corneal abrasions during agricultural work. Antimicrobial prophylaxis of corneal abrasions may help prevent corneal ulcers, but delays in initiation of therapy are frequent. A cluster-randomized trial was performed in Nepal to determine the effectiveness of a community-based corneal ulcer prevention program (clinicaltrials.gov #NCT01969786). The randomization unit was the Village Development Committee (VDC). VDCs in the study area with <15,000 people were eligible for inclusion. In the intervention arm, pre-existing Female Community Health Volunteers (FCHVs) were trained to diagnose corneal abrasions and provide a three-day course of ophthalmic antimicrobials. The primary outcome was incident corneal ulceration, determined by masked assessment of corneal photographs. Between February 4, 2014 and October 20, 2017, 12 VDCs were randomized to receive the intervention and 12 control VDCs to receive no intervention. 213,697 individuals were included on the baseline census. FCHVs diagnosed and provided antimicrobials for 4,777 corneal abrasions. Medication allergy was self-reported in 0.2%. The census identified 289 incident corneal opacities among 246,893 person-years in the intervention arm and 262 opacities among 239,170 person-years in the control arm (incidence 1.21, 95%CI 0.85–1.74 per 1000 person-years in the intervention arm and 1.18, 95%CI 0.82–1.70 in the control arm); intention-to-treat incidence rate ratio (IRR) 1.03, 95%CI 0.63–1.67; P=0.93. Exploratory subgroup analyses suggested the effectiveness might depend on geography (e.g., IRR 0.50, 95%CI 0.19–1.30 in rural areas versus IRR 1.31, 95%CI 0.86–1.99 in peri-urban or urban areas; P=0.04 for subgroup interaction). This trial failed to detect a reduction in incident corneal ulceration during the first three years of a community-based corneal ulcer prevention program. Further study may be warranted in more rural areas where basic eye care facilities are not available.