Clinical Trial: Corneal Ulcer Prevention Through Health Education
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Corneal Ulcer Prevention Through Health Education
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Aravind Eye Care System
Current Primary Outcome: Incidence of Corneal Ulcer [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Aravind Eye Care System
Dates:
Date Received: November 4, 2014
Date Started: December 2014
Date Completion: December 2017
Last Updated: November 5, 2014
Last Verified: November 2014
