An observational study in Corneal Ulcer, sponsored by Aravind Eye Care System. Status unknown. Per ClinicalTrials.gov, last updated 2014-11-06.
Sponsored by Aravind Eye Care System · Observational
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.
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.
60 studies on the registry are indexed under Corneal Ulcer; 8 are open to participants now.
This study's planned enrollment of 98,207 is above the median of 65 across 11 observational studies indexed under Corneal Ulcer.
Browse Corneal Ulcer studies →Aravind Eye Care System is the lead sponsor of 4 studies on the registry; none are open to participants now.
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42 villages eligible for the study will comprise a total population of 98,207
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Exclusion Criteria:
Study Group will have the field workers and active health education with referral mechanism
Other: Health Education
Control group will not have field workers and active health education. They will follow routine health care
Other: Health Education
Heath education will be given through awareness creation \& pamphlet distribution
Incidence of Corneal Ulcer
The primary outcome for the trial will be the incidence of corneal ulceration in the two study arms as measured by field examination.
Time frame: 2 years
No study locations are listed for this record.
This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Aravind Eye Care System