Village Integrated Eye Workers Trial

Village Integrated Eye Workers Trial

Sponsors

Lead Sponsor: University of California, San Francisco

Collaborator: National Eye Institute (NEI)
Seva Foundation
Bharatpur Eye Hospital

Source 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.

Overall Status Recruiting
Start Date 2014-02-01
Completion Date 2021-07-01
Primary Completion Date 2021-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of corneal ulceration in the two study arms as measured by corneal photography 3 years
Secondary Outcome
Measure Time Frame
Trial-based cost effectiveness analysis to determine the incremental cost per corneal ulcer prevented 3 years
Enrollment 275000
Condition
Intervention

Intervention Type: Other

Intervention Name: Corneal ulcer prevention program

Description: The corneal ulcer prevention intervention consists of training female community health volunteers to diagnose corneal abrasions and to treat the abrasions with 1% itraconazole and 1% chloramphenicol ointments 3 times a day for 3 days.

Arm Group Label: Corneal ulcer prevention program

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

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Tom M Lietman

Phone: 4155142163

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Bharatpur Eye Hospital - Seva Foundation Ram P Kandel [email protected] Ram P Kandel Principal Investigator
Location Countries

Nepal

Verification Date

2021-03-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Corneal ulcer prevention program

Type: Experimental

Description: 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.

Label: Control

Type: No Intervention

Description: Female community health volunteers (FCHV) residing in Village Development Committees (VDC) randomized to control (no intervention) will not receive additional training and will not undertake a promotional campaign in their communities.

Acronym VIEW
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Outcomes Assessor)

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