Corneal Ulcer Prevention Through Health Education

Corneal Ulcer Clinical Trial

— CUP  

Official title:

Corneal Ulcer Prevention Through Health Education

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02284698
• Other study ID #: Aravind-RES2013064CLI
• Status: Not yet recruiting
• Phase: N/A
• First received: November 4, 2014
• Last updated: November 5, 2014
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2014
• Source: Aravind Eye Care System
• Contact: Srinivasan M, MS, DO
• Phone: +914524356100
• Email: m.srinivasan[@]aravind.org
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98207
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Corneal Ulcer
• Ulcer

Intervention

Other:
• Health Education
Heath education will be given through awareness creation & pamphlet distribution

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aravind Eye Care System	Proctor Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No