Clinical trial NCT02284698: Corneal Ulcer Prevention Through Health Education
Official title: Corneal Ulcer Prevention Through Health Education
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corneal Ulcer
Lead sponsor: Aravind Eye Care System
Sponsor class: OTHER
Collaborators: name: Proctor Foundation
First posted: 2014-11-06
Enrollment: 98207
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 42 villages eligible for the study will comprise a total population of 98,207

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 description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of Corneal Ulcer
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Srinivasan M, Ravilla T, Vijayakumar V, Yesunesan D, Mani I, Whitcher JP, Oldenburg CE, O'Brien KS, Lietman TM, Keenan JD. Community Health Workers for Prevention of Corneal Ulcers in South India: A Cluster-Randomized Trial. Am J Ophthalmol. 2022 May;237:259-266. doi: 10.1016/j.ajo.2021.12.010. Epub 2021 Dec 21.