Village Integrated Eye Workers Trial

NCT ID: NCT01969786

Last Updated: 2025-04-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 223671 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2026-01-31

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.

Conditions

Corneal Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Corneal ulcer prevention program

Intervention Type: OTHER

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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Corneal ulcer prevention program

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.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Seva Foundation

OTHER

Sponsor Role: collaborator

Bharatpur Eye Hospital

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom M Lietman

Role: PRINCIPAL_INVESTIGATOR

University of California San Francisco Proctor Foundation

Krisianne M Aromin

Role: STUDY_DIRECTOR

University of California San Francisco Proctor Foundation

Locations

Bharatpur Eye Hospital - Seva Foundation

Bharatpur, , Nepal

Countries

Nepal

References

O'Brien KS, Byanju R, Kandel RP, Poudyal B, Gautam M, Gonzales JA, Porco TC, Whitcher JP, Srinivasan M, Upadhyay M, Lietman TM, Keenan JD; Village-Integrated Eye Worker Trial Group. Village-Integrated Eye Worker trial (VIEW): rationale and design of a cluster-randomised trial to prevent corneal ulcers in resource-limited settings. BMJ Open. 2018 Aug 10;8(8):e021556. doi: 10.1136/bmjopen-2018-021556.

Reference Type: BACKGROUND

PMID: 30099393 (View on PubMed)

O'Brien KS, Byanju R, Kandel RP, Poudyal B, Gonzales JA, Porco TC, Whitcher JP, Srinivasan M, Upadhyay M, Lietman TM, Keenan JD; Village-Integrated Eye Worker Trial Group. Village-integrated eye workers for prevention of corneal ulcers in Nepal (VIEW study): a cluster-randomised controlled trial. Lancet Glob Health. 2022 Apr;10(4):e501-e509. doi: 10.1016/S2214-109X(21)00596-9.

Reference Type: DERIVED

PMID: 35303460 (View on PubMed)

Other Identifiers

5U10EY022880

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10EY02280

Identifier Type: -

Identifier Source: org_study_id