Village-Integrated Eye Worker Trial II
VIEW II
1 other identifier
interventional
60,200
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 cases early and linking cases with appropriate care remain significant challenges. To address the global burden of avoidable blindness, eye care systems must determine optimal strategies for identifying people with or predisposed to visual impairment beyond opportunistic screening. Outreach programs can prevent blindness both by screening for asymptomatic disease like age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma and case detection of symptomatic disease like cataract and refractive error. Eye care systems have developed numerous approaches to these identification methods, including screening using telemedicine and case detection via cataract camps or health worker models, but no studies have been conducted on the comparative effectiveness or cost effectiveness of these various approaches. Technology promises to greatly improve access to sophisticated eye care. AMD, DR, and glaucoma can result in irreversible vision loss, and early diagnosis and effective treatment can prevent progression. Thus, mass screening programs may prevent progression and improve the vision of a population. However, mass screening for eye disease is currently not recommended. Although self-evident that early detection can prevent blindness for an individual, no randomized controlled trial has been able to demonstrate that screening improves visual acuity at the regional level. However, recent technological advances promise to dramatically change the equation by allowing non-medical personnel to use mobile, easy-to-use retinal imaging devices to diagnose screenable eye diseases such as AMD, DR, and glaucoma. Mobile technology could also transform the way clinics communicate with their patients, improving linkage to and retention in care. Optical coherence tomography (OCT) is an ideal test for screening. OCT can be performed through an undilated pupil and is less subject to optical aberrations due to cataract than is fundus photography. OCT machines have pre-installed algorithms to screen for glaucoma, and major anatomical abnormalities can easily be detected even by novice technicians. The infrared image allows detection of referable diabetic retinopathy, and newer OCT angiography machines offer even more discrimination of early diabetic retinopathy. OCT machines are ever more portable, and could be feasibly used in mobile screening programs. The investigators propose a large cluster-randomized trial to compare two population level blindness prevention programs: (1) a state-of-the-art screening program employing OCT, fundus photography, and intraocular pressure testing to screen for glaucoma, DR, and AMD followed by enhanced linkage-to-care to the local eye hospital, and (2) a screening program involving only visual acuity assessment. An initial door-to-door census will assess baseline visual acuity in both study arms. The investigators will compare visual acuity between the two arms through a second door-to-door census 9 years later (primary outcome).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2019
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
November 16, 2018
CompletedFirst Posted
Study publicly available on registry
November 26, 2018
CompletedStudy Start
First participant enrolled
April 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2029
July 11, 2025
July 1, 2025
10.4 years
November 16, 2018
July 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Pinhole visual acuity (logMAR) in people aged 50 years and older
Visual acuity will be assessed using the Peek Acuity mobile application during the final census.
9 years
Secondary Outcomes (4)
Incidence of visual impairment due to AMD, DR, or glaucoma
9 years
Bilateral blindness in people aged 50 years and older, defined as pinhole visual acuity worse than Snellen 20/400 (Metric Snellen worse than 6/120; logMAR worse than 1.3) in the better-seeing eye
9 years
Presenting visual acuity (logMAR) in people aged 50 years and older
9 years
Cost-effectiveness of the screening intervention
9 years
Other Outcomes (3)
Bilateral visual impairment in people aged 50 years and older, defined as pinhole visual acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48) in the better-seeing eye
9 years
Bilateral presenting visual impairment in people aged 50 years and older, defined as presenting visual acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48) in the better-seeing eye
9 years
Bilateral presenting blindness in people aged 50 years and older, defined as presenting visual acuity worse than Snellen 20/400 (Metric Snellen worse than 6/120; logMAR worse than 1.3) in the better-seeing eye
9 years
Study Arms (2)
Screening
EXPERIMENTALCase detection
ACTIVE COMPARATORInterventions
Presenting and pinhole visual acuity will be assessed using the Peek Acuity mobile application. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital.
OCT will be used to image the anterior segment, the macula, and the retinal nerve fiber layer. The images will be assessed for abnormalities and participants meeting referral criteria will be referred to the local eye hospital.
Intraocular pressure will be measured using an iCare tonometer. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital.
Referred participants will be followed closely by study staff to ensure completion of follow-up visits.
Fundus cameras will be used to image the macula and optic nerve. The images will be assessed for abnormalities and participants meeting referral criteria will be referred to the local eye hospital.
Eligibility Criteria
You may qualify if:
- Located in catchment area of Bharatpur Eye Hospital or Lumbini Eye Institute
- Reachable by non-4WD vehicle
- Urban or peri-urban
You may not qualify if:
- \- Local leaders unwilling to participate
- Person level
- years and older
- Residing in the community during the time of the census
- \- Unwilling to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Seva Foundationcollaborator
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94158, United States
Related Publications (1)
O'Brien KS, Stevens VM, Byanju R, Kandel RP, Bhandari G, Bhandari S, Melo JS, Porco TC, Lietman TM, Keenan JD; Group Information for the VIEW II Study Group. Cluster-randomised trial of community-based screening for eye disease in adults in Nepal: the Village-Integrated Eye Worker Trial II (VIEW II) trial protocol. BMJ Open. 2020 Oct 15;10(10):e040219. doi: 10.1136/bmjopen-2020-040219.
PMID: 33060092DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy Keenan
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2018
First Posted
November 26, 2018
Study Start
April 21, 2019
Primary Completion (Estimated)
August 31, 2029
Study Completion (Estimated)
August 31, 2029
Last Updated
July 11, 2025
Record last verified: 2025-07
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. A request form will be available on Open Science Framework (https://osf.io/fgvrt/); all requests will be approved by the executive committee of the trial before sharing data. GPS data will not be shared.