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临床试验/NCT02284698
NCT02284698Unknown不适用

Corneal Ulcer Prevention Through Health Education

Aravind Eye Care System0 个研究点目标入组 98,207 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
98,207
主要终点
Incidence of Corneal Ulcer

研究概览

简要总结

A community-randomized trial comparing villages randomized to receive an intervention consisting of a trained community health volunteer who brings patients to the nearest Vision Centers or Primary Health Care Centers for treatment after diagnosing a corneal abrasion to control villages receiving no additional intervention. The primary outcome of corneal ulcer will be measured by baseline and annual population-based census performed in both intervention and control villages by masked examiners from baseline to 24 months. Each resident in the village will be asked about their ocular history and, if suspected of having a corneal ulcer, will be examined for evidence of a corneal opacity. Annual visits will occur, coinciding with the end of the harvest season. In villages randomized to intervention, an active promotion campaign will be undertaken to urge residents to notify the village eye health worker within 24 hours of ocular trauma. In control villages, abrasions and ulcers will be treated if they present to a clinic or are found during the annual monitoring visits, but active promotion of corneal abrasion care will not be offered.

详细描述

Research Question: Can the investigators prevent corneal ulcers on a mass scale?

Aim 1: To determine whether diagnosis and prophylaxis of corneal abrasions by village health workers will reduce the incidence of corneal ulceration in rural South India. The investigators hypothesize that communities in which village eye health workers are available to diagnose and prophylax corneal abrasions will have a significantly lower incidence of corneal ulceration compared to communities without this service.

Aim 2: To determine the cost-effectiveness of a village eye worker program to prevent corneal ulcers. The investigators hypothesize that preventing corneal ulcers through a village eye worker program will be more cost-effective than the current standard of treating corneal ulcers after patients present at health care facilities.

Aim 3: To determine the incidence of corneal ulceration in this South Indian population. The investigators anticipate that the incidence of ulcers is lower than estimated in our 1995 incidence survey, but still far higher than that observed in the developed world.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Presence of a corneal abrasion
  • Willingness to be treated with topical antibiotic and antifungal ointments 3 times a day for 3 days
  • Appropriate consent

排除标准

  • Evidence of a corneal ulcer
  • Evidence of other acute eye disease requiring urgent care
  • Known allergy to study medications
  • Not willing to participate

结局指标

主要结局

Incidence of Corneal Ulcer

时间窗: 2 years

The primary outcome for the trial will be the incidence of corneal ulceration in the two study arms as measured by field examination.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. M.Srinivasan

Prinicpal Investigator

Aravind Eye Care System

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