Village Integrated Eye Workers Trial

Not Applicable

Active, not recruiting

• Conditions: Corneal Ulcer
• Interventions: Other: Corneal ulcer prevention program

• Registration Number: NCT01969786
• Lead Sponsor: University of California, San Francisco

Brief Summary

VIEW is a community-randomized trial designed to determine whether it is possible to prevent corneal ulcers on a large scale. The study compares the incidence of corneal ulceration between villages in which volunteers are trained to diagnose and treat corneal abrasions and villages which receive no intervention.

Detailed Description

Corneal ulceration is a leading cause of visual impairment globally, with a disproportionate burden in developing countries. Corneal opacity after ulceration is responsible for a significant proportion of blinding eye disease in Africa and Asia. While antimicrobial treatment is generally effective in eradicating infection, "successful" treatment is often associated with a poor visual outcome. The scarring that accompanies the resolution of infection leaves many eyes blind. It has been difficult to discern differences between different antimicrobials in a randomized controlled trial (RCT). In fact, only a single RCT with more than 50 subjects has found any significant difference between ulcer treatments. Thus, prevention of corneal ulceration may be our best opportunity to reduce morbidity associated with corneal ulceration.

Several non-randomized prevention studies in Nepal, Myanmar, and Bhutan have suggested that antibiotic ointment applied promptly after a corneal abrasion could dramatically lower the incidence of ulcers, relative to neighboring or historic controls. In Madurai, South India, a clinical trial demonstrated that abrasions randomized to topical antibacterial and antifungal prophylaxis were not significantly less likely to develop fungal ulcers than those randomized to antibacterial ointment alone, even though the region had a high incidence of fungal infection. This same trial also found that the incidence of ulcers in villages outside the prophylaxis program was far higher; these control villages were neighboring but not randomized, and it is possible that they were in some way different from the villages included in the program.

VIEW was designed to determine whether we can prevent corneal ulcers on a large scale. VIEW is a community-randomized trial comparing villages randomized to receive an intervention consisting of a trained community health volunteer providing antimicrobial ointment after 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 36 months. The examiners will photograph corneas of all residents who are suspected of having a corneal ulcer, with photographs later read by masked examiners. Each resident in the village will be examined for evidence of a corneal opacity and asked about their ocular history. In villages randomized to intervention, the trained community health volunteers will actively promote their services through regular meetings with local women's groups by encouraging 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 Timeline

• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-25
• Study Start: 2014-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 223671

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corneal ulcer prevention program	Corneal ulcer prevention program	Female community health volunteers (FCHV) residing in Village Development Committees (VDC) randomized to the corneal ulcer prevention arm will be trained to diagnose and treat corneal abrasions with antifungal (itraconazole) and antibiotic (chloramphenicol) ointments. FCHVs will promote their new services to their communities and encourage villagers who experience ocular trauma to present to them within 24 hours.

Primary Outcome Measures

Name	Time	Method
Incidence of corneal ulceration in the two study arms as measured by corneal photography	3 years

Secondary Outcome Measures

Name	Time	Method
Trial-based cost effectiveness analysis to determine the incremental cost per corneal ulcer prevented	3 years

Trial Locations

Locations (1)

Bharatpur Eye Hospital - Seva Foundation; 🇳🇵 Bharatpur, Nepal