Village Integrated Eye Workers Trial

描述（由申请方提供）：本研究的目的是评估抗生素软膏预防性治疗对降低角膜溃疡和随后失明发生率的有效性。我们比较社区随机接受密集的健康促进工作，旨在早期预防角膜擦伤的社区接受标准护理（无积极干预）。角膜溃疡是全球失明的主要原因，并且一旦感染存在，就难以实质性地改善眼睛的视觉潜能。个体随机对照试验未能成功证明不同抗菌药物或抗生素治疗的临床结局存在较大差异。前瞻性队列研究表明，抗生素预防 有效减少角膜溃疡，但社区随机临床试验是必要的，以提供明确的证据，干预措施的有效性与抗生素预防在社区一级。我们希望这项研究将通过以下具体目标为这种干预提供证据基础：1）确定抗生素预防是否 在一项社区随机试验中，角膜擦伤后使用抗生素可降低角膜溃疡的发生率。2)评估微生物性角膜炎预防性干预的成本和成本效益。3)确定印度Taml Nadu地区角膜溃疡和擦伤的发病率。还没有针对微生物性角膜炎进行的社区随机试验。由于基础设施和后勤要求以及道德方面的考虑，这些审判很难进行。我们通过建立在加州大学旧金山弗朗西斯科和印度马杜赖的Aravind眼科医院之间的合作来解决这个问题。Aravind拥有社区外展和视力中心的现有基础设施，可以大规模完成本研究。对照社区的患者如果寻求治疗将得到治疗，因为不提供治疗是不道德的，但这些社区将不会得到积极的健康促进活动。如果被证明是有效的，这项研究将提供一个具有成本效益的，可扩展的干预措施，可以大大减少失明的负担，特别是在发展中国家的农村社区的明确证据。

DESCRIPTION (provided by applicant): The objective of this study is to assess the efficacy of antibiotic ointment prophylaxis to reduce incidence of corneal ulceration and subsequent blindness. We compare communities randomized to receive an intensive health promotion effort aimed at early prophylaxis for corneal abrasion to communities receiving standard-of care (no active intervention). Corneal ulceration is a leading cause of blindness globally, and once infection is present it is difficult to substantially improve visual potential of the eye. Individully randomized controlled trials have been unsuccessful at demonstrating large differences in clinical outcomes with different antimicrobial or adjunctive therapies. Prospective cohort studies have suggested that antibiotic prophylaxis Is effective at reducing corneal ulceration, but a community randomized clinical trial is necessary to provide definitive evidence of the efficacy of interventions with antibiotic prophylaxis at the community level. We expect that this study will provide an evidence base for such an intervention through the following specific aims: 1) to determine if antibiotic prophylaxis after corneal abrasion reduces the incidence of corneal ulceration in a community randomized trial. 2) To assess the costs and cost-effectiveness of a preventative intervention for microbial keratitis. 3) To determine the incidence of corneal ulceration and abrasion in this district of Taml Nadu, India. No community-randomized trial has ever been performed for microbial keratitis. These trials are difficult to conduct, because of infrastructure and logistical requirements as wel as ethical considerations. We address this by building on our collaborations between the University of California, San Francisco and the Aravind Eye Hospital in Madurai, India. Aravind has an existing infrastructure of community outreach and vision centers that will allow for this study to be completed at a large scale. Patients in control communities will receive treatment should they seek it, as it would be unethical not to provide treatment, but these communities will not receive active health promotion activities. If proven to be effective, this study will provide definitive evidence on a cost-effective, scalable intervention that could substantially reduce the burden of blindness particularly in rural communities in the developing world.