Village Integrated Eye Workers Trial
VIEW
2 other identifiers
interventional
223,671
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2013
CompletedFirst Posted
Study publicly available on registry
October 25, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedApril 7, 2025
April 1, 2025
11.9 years
October 21, 2013
April 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of corneal ulceration in the two study arms as measured by corneal photography
3 years
Secondary Outcomes (1)
Trial-based cost effectiveness analysis to determine the incremental cost per corneal ulcer prevented
3 years
Other Outcomes (2)
Incidence of corneal ulceration in the non-intervention arm corrected by passive surveillance
3 years
Long-term follow-up of incidence of corneal ulceration in the two study arms as measured by corneal photography
5 years
Study Arms (2)
Corneal ulcer prevention program
EXPERIMENTALFemale 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.
Control
NO INTERVENTIONFemale 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.
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- National Eye Institute (NEI)collaborator
- Seva Foundationcollaborator
- Bharatpur Eye Hospitalcollaborator
Study Sites (1)
Bharatpur Eye Hospital - Seva Foundation
Bharatpur, Nepal
Related Publications (2)
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.
PMID: 30099393BACKGROUNDO'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.
PMID: 35303460DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tom M Lietman
University of California San Francisco Proctor Foundation
- STUDY DIRECTOR
Krisianne M Aromin
University of California San Francisco Proctor Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2013
First Posted
October 25, 2013
Study Start
February 1, 2014
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
April 7, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- De-identified data will be shared after publication of the major findings of the study, which we anticipate will occur around 6 months after the study conclusion.
- Access Criteria
- De-identified data will be available upon request.
De-identified data will be shared with other investigators upon request after the conclusion of the study. All requests will be approved by the executive committee of the trial before sharing data. GPS data will not be shared.