Corneal Ulcer Prevention Through Health Education (CUP)

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.

Study Overview

• Status: Unknown
• Conditions: Corneal Ulcer
• Intervention / Treatment: Other: Health Education

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.

• Study Type: Observational
• Enrollment (Anticipated): 98207

Contacts and Locations

• Study Contact: Name: Srinivasan M, MS, DO; Phone Number: 311 +914524356100; Email: m.srinivasan@aravind.org
• Study Contact Backup: Name: Vijayakumar V, MA; Phone Number: 529 +914524356500; Email: vijay@aravind.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

42 villages eligible for the study will comprise a total population of 98,207

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; Study Group will have the field workers and active health education with referral mechanism	Other: Health Education; Heath education will be given through awareness creation & pamphlet distribution
Control Group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Aravind Eye Care System
• Collaborators: Proctor Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 4, 2014
• First Submitted That Met QC Criteria: November 5, 2014
• First Posted (Estimate): November 6, 2014

Study Record Updates

• Last Update Posted (Estimate): November 6, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Eye Diseases; Keratitis; Corneal Diseases; Eye Infections; Ulcer; Corneal Ulcer
• Other Study ID Numbers: Aravind-RES2013064CLI