CataractVIEW II PilotNCT03278587
Village-Integrated Eye Worker Trial II - Pilot
A study testing Community-based screening program, Cataract camp program and Community health worker program in people with Cataract and Glaucoma, run by University of California, San Francisco at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Glaucoma, Age Related Macular Degeneration
- What is being tested?
- Community-based screening program, Cataract camp program and Community health worker program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87,992 participants
- Where
- 1 siteNepal
- Study dates
- 31 May 2018to 12 Feb 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Specific Aim 1: to determine whether screening leads to increased visual acuity compared to the cataract camp approach.
Specific Aim 2: to determine whether a community health volunteer program increases the rate of cataract surgery compared to a no program.
- Conditions
- Cataract, Glaucoma, Age Related Macular Degeneration, Diabetic Retinopathy, Refractive Errors
- Being tested
- Community-based screening program, Cataract camp program, Community health worker program
- Medical subject headings
- Cataract, Glaucoma, Macular Degeneration, Diabetic Retinopathy, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based screening programOther
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.
Cataract camp programOther
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.
Community health worker programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Community-based screening | Active comparator | Not described Receives: Other: Community-based screening program |
| Cataract camp program | Active comparator | Not described Receives: Other: Cataract camp program |
| Community health worker program | Active comparator | Not described Receives: Other: Community health worker program |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Primary outcome for specific aim 1, comparison between screening and case detection arms
Measured: 1 year
Cataract surgical rate
Primary outcome for specific aim 2, comparison between community health worker program and no program arms
Measured: 1 year
Secondary outcomes (3)
Cost-effectiveness
Cost-effectiveness of all 4 arms will be assessed
Measured: 1 year
Visual acuity
Visual acuity of population 50 years and older in all arms will be compared
Measured: 1 year
Number of cases of ocular disease detected
Number of cases of ocular disease in the screening and case detection arms will be compared
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start31 May 2018
- Primary completion12 Feb 2023
- Study completion12 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87,992 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Seva Foundation
- Responsible party
- Sponsor
- Investigators
- Jeremy D Keenan, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278587
- Sponsor's protocol ID
- 17-22776
- Acronym
- VIEW II Pilot
- Status last verified
- Apr 2026
- First submitted
- 8 Sep 2017
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No