Village-Integrated Eye Worker Trial II - Pilot
VIEW II Pilot
1 other identifier
interventional
87,992
1 country
1
Brief Summary
The vast majority of blindness is avoidable. The World Health Organization (WHO) estimates that 80% of cases of visual impairment could be prevented or reversed with early diagnosis and treatment. The leading causes of visual impairment are cataract and refractive error, followed by glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy (DR). Loss of vision from these conditions is not inevitable; however, identifying at-risk cases and linking cases with appropriate care remain significant challenges. Eye health care systems must determine optimal strategies for reaching people outside of their immediate orbit in order to reduce visual impairment. Visual impairment can be reduced by case detection of prevalent disease like cataract and refractive error, or by screening for early disease like glaucoma, AMD, and DR and preventing progression. Systems around the world have developed numerous approaches to both case detection and screening but there is very little research to support the choice of allocating resources to case detection or screening and little data exists on the cost effectiveness of the various approaches to each. VIEW II Pilot is a cluster-randomized trial to determine the effectiveness of different approaches to community-based case detection and screening for ocular disease. Communities will be randomized to one of four arms: 1) a comprehensive ocular screening program, 2) a cataract camp-based program, 3) a community health worker-based program, and 4) no program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2017
CompletedFirst Posted
Study publicly available on registry
September 11, 2017
CompletedStudy Start
First participant enrolled
May 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2023
CompletedMay 4, 2026
April 1, 2026
4.7 years
September 8, 2017
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Visual acuity
Primary outcome for specific aim 1, comparison between screening and case detection arms
1 year
Cataract surgical rate
Primary outcome for specific aim 2, comparison between community health worker program and no program arms
1 year
Secondary Outcomes (3)
Cost-effectiveness
1 year
Visual acuity
1 year
Number of cases of ocular disease detected
1 year
Study Arms (4)
Community-based screening
ACTIVE COMPARATORCataract camp program
ACTIVE COMPARATORCommunity health worker program
ACTIVE COMPARATORNo intervention
NO INTERVENTIONInterventions
In communities randomized to receive the screening program, all adults aged 50 and older will be eligible to receive screening for ocular disease. Screening assessments include visual acuity, refraction, intra-ocular pressure, fundus photography, and anterior segment photography. Participants meeting criteria for referral based on screening assessments will be referred to the nearest eye care center or eye hospital for further evaluation.
In communities randomized to receive the cataract camp program, all adults aged 50 and older will be eligible to participate in a routine cataract camp run by Bharatpur Eye Hospital. Trained ophthalmic personnel and assistants will perform case detection for cataract via visual acuity, pen light exam, and indirect ophthalmoscope exam per Bharatpur Eye Hospital's standard cataract camp program. Participants with cataracts will be referred to the nearest eye care center or eye hospital for further evaluation.
In communities randomized to receive the community health worker program, all adults aged 50 and older will be eligible to participate. Existing community health workers will be trained to perform case detection for cataract via visual acuity assessment. Participants with cataracts will be referred to the nearest eye care center or eye hospital for further evaluation.
Eligibility Criteria
You may qualify if:
- Wards in the Chitwan and Nawalparasi districts that participated in the VIEW trial and have not received a cataract camp in the past 6 months.
- Individuals aged 50 and older will be eligible to participate in the screening program, cataract camp programs, and the FCHV program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Seva Foundationcollaborator
Study Sites (1)
Bharatpur Eye Hospital
Bharatpur, Chitwan, Nepal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy D Keenan, MD, MPH
University of California, San Francisco
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
September 8, 2017
First Posted
September 11, 2017
Study Start
May 31, 2018
Primary Completion
February 12, 2023
Study Completion
February 12, 2023
Last Updated
May 4, 2026
Record last verified: 2026-04