Corneal Ulcer Prevention Through Health Education

NCT02284698 | Unknown

• 1 other identifier: Aravind-RES2013064CLI
• Study Type: observational
• Target: 98,207
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Corneal Ulcer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Study Group

Study Group will have the field workers and active health education with referral mechanism

Other: Health Education

Control Group

Control group will not have field workers and active health education. They will follow routine health care

Other: Health Education

Interventions

Health Education OTHER

Heath education will be given through awareness creation \& pamphlet distribution

Control Group; Study Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aravind Eye Care System: lead
• Proctor Foundation: collaborator

Related Publications (1)

• 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.

  PMID: 34942106 DERIVED

MeSH Terms

Conditions

Corneal Ulcer

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases

Central Study Contacts

Srinivasan M, MS, DO

CONTACT

+914524356100; m.srinivasan@aravind.org

Vijayakumar V, MA

CONTACT

+914524356500; vijay@aravind.org

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 6, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 6, 2014

Record last verified: 2014-11