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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Village-Integrated Eye Worker Trial II - Pilot
- ClinicalTrials.gov ID
- NCT03278587
- Acronym / sponsor ID
- VIEW II Pilot / 17-22776
- Conditions
- Cataract, Glaucoma, Age Related Macular Degeneration, Diabetic Retinopathy, Refractive Errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87,992 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Seva Foundation
- Study start
- 31 May 2018 (actual)
- Primary completion
- 12 Feb 2023 (actual)
- Study completion
- 12 Feb 2023 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Community-based screening | Active comparator | Other: Community-based screening program |
| Cataract camp program | Active comparator | Other: Cataract camp program |
| Community health worker program | Active comparator | Other: Community health worker program |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based screening programIn 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. | Other | Community-based screening |
| Cataract camp programIn 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. | Other | Cataract camp program |
| Community health worker programIn 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. | Other | Community health worker program |
Primary outcome
Visual acuity
Time frame: 1 year
Primary outcome for specific aim 1, comparison between screening and case detection arms
Cataract surgical rate
Time frame: 1 year
Primary outcome for specific aim 2, comparison between community health worker program and no program arms
3 secondary outcomes
Cost-effectiveness
Time frame: 1 year
Visual acuity
Time frame: 1 year
Number of cases of ocular disease detected
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy D Keenan, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.