Age-related Macular DegenerationVIEW IINCT03752840
Village-Integrated Eye Worker Trial II
A study testing Visual acuity (presenting and pinhole), Optical coherence tomography (OCT) and Intraocular pressure in people with Age-related Macular Degeneration and Diabetic Retinopathy, run by University of California, San Francisco at 1 site in United States.
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 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration, Diabetic Retinopathy, Glaucoma
- What is being tested?
- Visual acuity (presenting and pinhole), Optical coherence tomography (OCT) and Intraocular pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60,200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2019to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Located in catchment area of Bharatpur Eye Hospital or Lumbini Eye Institute
- Reachable by non-4WD vehicle
- Urban or peri-urban
- 60 years and older
- Residing in the community during the time of the census
Who cannot join
- Local leaders unwilling to participate
- Person level
- Unwilling to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
Jeremy Keenan, MD, MPH, 415-936-3164, jeremy.keenan@ucsf.edu
Atnasia Mekonnen, MS, 8186186681, atnasia.mekonnen@ucsf.edu
About this study
Official title: Village-Integrated Eye Worker Trial II (VIEW II):A Cluster-randomized Trial of the Effectiveness of Community-based Ocular Disease Screening
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.
Read more
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).
Read the detailed description
The research will consist of a large cluster-randomized trial in which all clusters receive visual acuity screening during a baseline census, and then half subsequently receive screening with OCT, fundus photography, and intraocular pressure testing with an iCare tonometer. Participants with abnormal results will be referred to the local eye hospital for examination and treatment. Repeat visual acuity assessment will be performed 9 years later. Those with visual impairment at the time of the final census, defined as visual acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48), will receive a comprehensive eye exam to determine the cause of visual impairment.
Specific Aim 1 - Visual Acuity: To determine whether an intensive screening program results in better visual acuity at 9 years than screening with visual acuity testing alone. The investigators hypothesize that individuals from clusters randomized to the intensive screening program will have better visual acuity compared to those receiving visual acuity testing alone.
Specific Aim 2 - Eye Disease: To determine whether an intensive screening program reduces the incidence of visual impairment due to AMD, DR, or glaucoma. The investigators hypothesize that incident visual impairment due to AMD, DR, or glaucoma will be less common in clusters randomized to the intensive screening program.
- Being tested
- Visual acuity (presenting and pinhole), Optical coherence tomography (OCT), Intraocular pressure, Active linkage to care, Fundus Photography
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual acuity (presenting and pinhole)Other
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.
Optical coherence tomography (OCT)Other
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 pressureOther
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.
Active linkage to careOther
Referred participants will be followed closely by study staff to ensure completion of follow-up visits.
Fundus PhotographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening | Experimental | Not described Receives: Other: Visual acuity (presenting and pinhole); Other: Optical coherence tomography (OCT); Other: Intraocular pressure; Other: Active linkage to care; Other: Fundus Photography |
| Case detection | Active comparator | Not described Receives: Other: Visual acuity (presenting and pinhole) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pinhole visual acuity (logMAR) in people aged 60 years and older
Visual acuity will be assessed using the Peek Acuity mobile application during the final census.
Measured: 9 years
Secondary outcomes (4)
Incidence of visual impairment due to AMD, DR, or glaucoma
Participants with incident visual impairment, defined as Snellen worse than 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48), at the time of the final census will receive a comprehensive eye exam to determine the cause of visual impairment
Measured: 9 years
Bilateral blindness in people aged 60 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
Visual acuity will be assessed using the Peek Acuity mobile application during the final census.
Measured: 9 years
Presenting visual acuity (logMAR) in people aged 60 years and older
Visual acuity will be assessed using the Peek Acuity mobile application during the final census.
Measured: 9 years
Cost-effectiveness of the screening intervention
Costs associated with the screening intervention will be actively recorded during the study period and number of cases of AMD, DR, and glaucoma diagnosed and visual acuity as assessed with Peek Acuity during the final census will be used to evaluate effectiveness.
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start21 Apr 2019
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular DegenerationStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Seva Foundation
- Responsible party
- Sponsor
- Investigators
- Jeremy Keenan, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752840
- Sponsor's protocol ID
- 17-22776-2
- Acronym
- VIEW II
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2018
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33060092
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Village-Integrated Eye Worker Trial II (VIEW II):A Cluster-randomized Trial of the Effectiveness of Community-based Ocular Disease Screening
- ClinicalTrials.gov ID
- NCT03752840
- Acronym / sponsor ID
- VIEW II / 17-22776-2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60,200 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Seva Foundation
- Study start
- 21 Apr 2019 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 26 Nov 2018 (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 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).
Detailed description
The research will consist of a large cluster-randomized trial in which all clusters receive visual acuity screening during a baseline census, and then half subsequently receive screening with OCT, fundus photography, and intraocular pressure testing with an iCare tonometer. Participants with abnormal results will be referred to the local eye hospital for examination and treatment. Repeat visual acuity assessment will be performed 9 years later. Those with visual impairment at the time of the final census, defined as visual acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48), will receive a comprehensive eye exam to determine the cause of visual impairment.
Specific Aim 1 - Visual Acuity: To determine whether an intensive screening program results in better visual acuity at 9 years than screening with visual acuity testing alone. The investigators hypothesize that individuals from clusters randomized to the intensive screening program will have better visual acuity compared to those receiving visual acuity testing alone.
Specific Aim 2 - Eye Disease: To determine whether an intensive screening program reduces the incidence of visual impairment due to AMD, DR, or glaucoma. The investigators hypothesize that incident visual impairment due to AMD, DR, or glaucoma will be less common in clusters randomized to the intensive screening program.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening | Experimental | Other: Visual acuity (presenting and pinhole), Other: Optical coherence tomography (OCT), Other: Intraocular pressure, Other: Active linkage to care, Other: Fundus Photography |
| Case detection | Active comparator | Other: Visual acuity (presenting and pinhole) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Located in catchment area of Bharatpur Eye Hospital or Lumbini Eye Institute
- Reachable by non-4WD vehicle
- Urban or peri-urban
- 60 years and older
- Residing in the community during the time of the census
Key exclusion criteria (3 listed)
- Local leaders unwilling to participate
- Person level
- Unwilling to participate
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 |
|---|---|---|
| Visual acuity (presenting and pinhole)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. | Other | Case detection, Screening |
| Optical coherence tomography (OCT)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. | Other | Screening |
| Intraocular pressureIntraocular pressure will be measured using an iCare tonometer. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital. | Other | Screening |
| Active linkage to careReferred participants will be followed closely by study staff to ensure completion of follow-up visits. | Other | Screening |
| Fundus PhotographyFundus 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. | Other | Screening |
Primary outcome
Pinhole visual acuity (logMAR) in people aged 60 years and older
Time frame: 9 years
Visual acuity will be assessed using the Peek Acuity mobile application during the final census.
4 secondary outcomes
Incidence of visual impairment due to AMD, DR, or glaucoma
Time frame: 9 years
Bilateral blindness in people aged 60 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
Time frame: 9 years
Presenting visual acuity (logMAR) in people aged 60 years and older
Time frame: 9 years
Cost-effectiveness of the screening intervention
Time frame: 9 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Derived from this study: PubMed 33060092O'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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Jeremy Keenan 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 Visual acuity (presenting and pinhole), Optical coherence tomography (OCT) and Intraocular pressure in people with Age-related Macular Degeneration and Diabetic Retinopathy, run by University of California, San Francisco at 1 site in United States.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Jun 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krisianne M Aromin, BS ((415) 476-1442, krisianne.aromin@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pinhole visual acuity (logMAR) in people aged 60 years and older (time frame: 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03752840, which also lists 1 linked publication.
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 9 Jun 2026.