Village Integrated Eye Workers Trial

村综合眼科工作者试验

基本信息

批准号：
8737261
负责人：
THOMAS M LIETMAN
金额：
$ 59.35万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-30 至 2018-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8737261
关键词：
Address Africa Anti-Bacterial Agents Antibiotic Prophylaxis Antibiotics Antifungal Agents Area Asia Bhutan Blindness California Caring Censuses Chloramphenicol Cicatrix Clinic Clinical Clinical Trials Cohort Studies Collaborations Communities Community Health Community Outreach Cornea Corneal Abrasion Corneal Diseases Corneal Opacity Corneal Ulcer Developing Countries Diagnosis Epidemiology Ethics Eye Eye diseases Harvest Health Health Promotion Health Status Health care facility Healthcare Hospitals Hour Incidence Incidence Study India Infection Intervention Keratitis Lead Leprosy Masks Measures Methods Monitor Morbidity - disease rate Myanmar Mycoses Nepal Ointments Onchocerciasis Outcome Patients Persons Policies Population Prevention Prevention program Prophylactic treatment Randomized Randomized Clinical Trials Randomized Controlled Trials Reading Recording of previous events Relative (related person)Research Research Infrastructure Resolution Rural Rural Community San Francisco Seasons Services Surveys Trachoma Training Treatment Efficacy Ulcer United States Universities Village Health Workers Vision Visit Visual Visual impairment Wages antimicrobial blind cost cost effective cost effectiveness effective intervention effective therapy evidence base improved microbial population based prevent primary outcome programs prospective randomized trial scale up topical antibacterial treatment program trial comparing uptake volunteer

项目摘要

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.

描述（由申请人提供）：这项研究的目的是评估预防抗生素软膏的功效，以减少角膜溃疡的发生率和随后的失明。我们将随机的社区进行比较，以接受旨在早期预防角膜磨损的密集促进努力，以获得获得标准护理的社区（无积极干预）。角膜溃疡是全球失明的主要原因，一旦存在感染，就很难实质上提高眼睛的视觉潜力。个体随机对照试验未成功证明不同抗菌或辅助疗法的临床结果差异很大。前瞻性队列研究表明抗生素预防有效地减少了角膜溃疡，但是社区随机临床试验对于提供了在社区层面提供抗生素预防的干预措施有效性的明确证据。我们预计这项研究将通过以下特定目的为这种干预提供证据基础：1）确定是否预防抗生素角膜磨损后，在社区随机试验中降低了角膜溃疡的发生率。 2）评估微生物角膜炎预防性干预的成本和成本效益。 3）确定印度塔姆·纳杜（Taml Nadu）该地区的角膜溃疡和磨损的发生率。从未对微生物角膜炎进行过社区随机试验。这些试验很难进行，因为基础设施和后勤要求是道德考虑。我们通过建立加利福尼亚大学，旧金山大学和印度马杜赖的Aravind眼科医院之间的合作来解决这一问题。 Aravind拥有社区外展和视觉中心的现有基础设施，可以大规模完成这项研究。对照社区中的患者寻求治疗将获得治疗，因为不提供治疗是不道德的，但是这些社区不会接受积极的健康促进活动。如果被证明是有效的，这项研究将提供有关一种具有成本效益，可扩展干预措施的明确证据，该证据可能会大大减轻盲人负担，尤其是在发展中国家的农村社区中。