Corneal UlcerVIEWNCT01969786
Village Integrated Eye Workers Trial
A study testing Corneal ulcer prevention program in people with Corneal Ulcer, run by University of California, San Francisco at 1 site in Nepal.
Trial summary
VIEW is a community-randomized trial designed to determine whether it is possible to prevent corneal ulcers on a large scale. The study compares the incidence of corneal ulceration between villages in which volunteers are trained to diagnose and treat corneal abrasions and villages which receive no intervention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corneal Ulcer
- What is being tested?
- Corneal ulcer prevention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223,671 participants
- Where
- 1 siteNepal
- Study dates
- Feb 2014to Mar 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of a corneal abrasion
- Willingness to be treated with topical antibiotic and antifungal ointments 3 times a day for 3 days
- Appropriate consent
Who cannot join
- Evidence of a corneal ulcer
- Evidence of other acute eye disease requiring urgent care
- Known allergy to study medications
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
VIEW is a community-randomized trial designed to determine whether it is possible to prevent corneal ulcers on a large scale. The study compares the incidence of corneal ulceration between villages in which volunteers are trained to diagnose and treat corneal abrasions and villages which receive no intervention.
Read the detailed description
Corneal ulceration is a leading cause of visual impairment globally, with a disproportionate burden in developing countries. Corneal opacity after ulceration is responsible for a significant proportion of blinding eye disease in Africa and Asia. While antimicrobial treatment is generally effective in eradicating infection, "successful" treatment is often associated with a poor visual outcome. The scarring that accompanies the resolution of infection leaves many eyes blind. It has been difficult to discern differences between different antimicrobials in a randomized controlled trial (RCT). In fact, only a single RCT with more than 50 subjects has found any significant difference between ulcer treatments. Thus, prevention of corneal ulceration may be our best opportunity to reduce morbidity associated with corneal ulceration.
Several non-randomized prevention studies in Nepal, Myanmar, and Bhutan have suggested that antibiotic ointment applied promptly after a corneal abrasion could dramatically lower the incidence of ulcers, relative to neighboring or historic controls. In Madurai, South India, a clinical trial demonstrated that abrasions randomized to topical antibacterial and antifungal prophylaxis were not significantly less likely to develop fungal ulcers than those randomized to antibacterial ointment alone, even though the region had a high incidence of fungal infection. This same trial also found that the incidence of ulcers in villages outside the prophylaxis program was far higher; these control villages were neighboring but not randomized, and it is possible that they were in some way different from the villages included in the program.
VIEW was designed to determine whether we can prevent corneal ulcers on a large scale. VIEW is a community-randomized trial comparing villages randomized to receive an intervention consisting of a trained community health volunteer providing antimicrobial ointment after a corneal abrasion to control villages receiving no additional intervention. The primary outcome of corneal ulcer will be measured by baseline and annual population-based census performed in both intervention and control villages by masked examiners from baseline to 36 months. The examiners will photograph corneas of all residents who are suspected of having a corneal ulcer, with photographs later read by masked examiners. Each resident in the village will be examined for evidence of a corneal opacity and asked about their ocular history. In villages randomized to intervention, the trained community health volunteers will actively promote their services through regular meetings with local women's groups by encouraging residents to notify the village eye health worker within 24 hours of ocular trauma. In control villages, abrasions and ulcers will be treated if they present to a clinic or are found during the annual monitoring visits, but active promotion of corneal abrasion care will not be offered.
- Conditions
- Corneal Ulcer
- Being tested
- Corneal ulcer prevention program
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal ulcer prevention programOther
The corneal ulcer prevention intervention consists of training female community health volunteers to diagnose corneal abrasions and to treat the abrasions with 1% itraconazole and 1% chloramphenicol ointments 3 times a day for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Corneal ulcer prevention program | Experimental | Female community health volunteers (FCHV) residing in Village Development Committees (VDC) randomized to the corneal ulcer prevention arm will be trained to diagnose and treat corneal abrasions with antifungal (itraconazole) and antibiotic (chloramphenicol) ointments. FCHVs will promote their new services to their communities and encourage villagers who experience ocular trauma to present to them within 24 hours. Receives: Other: Corneal ulcer prevention program |
| Control | No intervention | Female community health volunteers (FCHV) residing in Village Development Committees (VDC) randomized to control (no intervention) will not receive additional training and will not undertake a promotional campaign in their communities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of corneal ulceration in the two study arms as measured by corneal photography
Measured: 3 years
Secondary outcomes (1)
Trial-based cost effectiveness analysis to determine the incremental cost per corneal ulcer prevented
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startFeb 2014
- Primary completionMar 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corneal UlcerStudies 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
- 223,671 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Seva Foundation, Bharatpur Eye Hospital
- Responsible party
- Sponsor
- Investigators
- Tom M Lietman, Principal investigator, University of California San Francisco Proctor FoundationKrisianne M Aromin, Study director, University of California San Francisco Proctor Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969786
- Sponsor's protocol ID
- U10EY02280
- Other IDs
- 5U10EY022880
- Acronym
- VIEW
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2013
- Last updated
- 14 Sep 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. 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, Byanju R, Kandel RP, Poudyal B, Gautam M, Gonzales JA, Porco TC, Whitcher JP, Srinivasan M, Upadhyay M, Lietman TM, Keenan JD; Village-Integrated Eye Worker Trial Group. Village-Integrated Eye Worker trial (VIEW): rationale and design of a cluster-randomised trial to prevent corneal ulcers in resource-limited settings. BMJ Open. 2018 Aug 10;8(8):e021556. doi: 10.1136/bmjopen-2018-021556.
PubMed 30099393O'Brien KS, Byanju R, Kandel RP, Poudyal B, Gonzales JA, Porco TC, Whitcher JP, Srinivasan M, Upadhyay M, Lietman TM, Keenan JD; Village-Integrated Eye Worker Trial Group. Village-integrated eye workers for prevention of corneal ulcers in Nepal (VIEW study): a cluster-randomised controlled trial. Lancet Glob Health. 2022 Apr;10(4):e501-e509. doi: 10.1016/S2214-109X(21)00596-9.
PubMed 35303460
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Village Integrated Eye Workers Trial
- ClinicalTrials.gov ID
- NCT01969786
- Acronym / sponsor ID
- VIEW / U10EY02280
- Conditions
- Corneal Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223,671 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Seva Foundation, Bharatpur Eye Hospital
- Study start
- Feb 2014 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 25 Oct 2013 (estimated)
- 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.
VIEW is a community-randomized trial designed to determine whether it is possible to prevent corneal ulcers on a large scale. The study compares the incidence of corneal ulceration between villages in which volunteers are trained to diagnose and treat corneal abrasions and villages which receive no intervention.
Detailed description
Corneal ulceration is a leading cause of visual impairment globally, with a disproportionate burden in developing countries. Corneal opacity after ulceration is responsible for a significant proportion of blinding eye disease in Africa and Asia. While antimicrobial treatment is generally effective in eradicating infection, "successful" treatment is often associated with a poor visual outcome. The scarring that accompanies the resolution of infection leaves many eyes blind. It has been difficult to discern differences between different antimicrobials in a randomized controlled trial (RCT). In fact, only a single RCT with more than 50 subjects has found any significant difference between ulcer treatments. Thus, prevention of corneal ulceration may be our best opportunity to reduce morbidity associated with corneal ulceration.
Several non-randomized prevention studies in Nepal, Myanmar, and Bhutan have suggested that antibiotic ointment applied promptly after a corneal abrasion could dramatically lower the incidence of ulcers, relative to neighboring or historic controls. In Madurai, South India, a clinical trial demonstrated that abrasions randomized to topical antibacterial and antifungal prophylaxis were not significantly less likely to develop fungal ulcers than those randomized to antibacterial ointment alone, even though the region had a high incidence of fungal infection. This same trial also found that the incidence of ulcers in villages outside the prophylaxis program was far higher; these control villages were neighboring but not randomized, and it is possible that they were in some way different from the villages included in the program.
VIEW was designed to determine whether we can prevent corneal ulcers on a large scale. VIEW is a community-randomized trial comparing villages randomized to receive an intervention consisting of a trained community health volunteer providing antimicrobial ointment after a corneal abrasion to control villages receiving no additional intervention. The primary outcome of corneal ulcer will be measured by baseline and annual population-based census performed in both intervention and control villages by masked examiners from baseline to 36 months. The examiners will photograph corneas of all residents who are suspected of having a corneal ulcer, with photographs later read by masked examiners. Each resident in the village will be examined for evidence of a corneal opacity and asked about their ocular history. In villages randomized to intervention, the trained community health volunteers will actively promote their services through regular meetings with local women's groups by encouraging residents to notify the village eye health worker within 24 hours of ocular trauma. In control villages, abrasions and ulcers will be treated if they present to a clinic or are found during the annual monitoring visits, but active promotion of corneal abrasion care will not be offered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corneal ulcer prevention program | Experimental | Other: Corneal ulcer prevention programFemale community health volunteers (FCHV) residing in Village Development Committees (VDC) randomized to the corneal ulcer prevention arm will be trained to diagnose and treat corneal abrasions with antifungal (itraconazole) and antibiotic (chloramphenicol) ointments. FCHVs will promote their new services to their communities and encourage villagers who experience ocular trauma to present to them within 24 hours. |
| Control | No intervention | –Female community health volunteers (FCHV) residing in Village Development Committees (VDC) randomized to control (no intervention) will not receive additional training and will not undertake a promotional campaign in their communities. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of a corneal abrasion
- Willingness to be treated with topical antibiotic and antifungal ointments 3 times a day for 3 days
- Appropriate consent
Key exclusion criteria (4 listed)
- Evidence of a corneal ulcer
- Evidence of other acute eye disease requiring urgent care
- Known allergy to study medications
- Not willing 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 |
|---|---|---|
| Corneal ulcer prevention programThe corneal ulcer prevention intervention consists of training female community health volunteers to diagnose corneal abrasions and to treat the abrasions with 1% itraconazole and 1% chloramphenicol ointments 3 times a day for 3 days. | Other | Corneal ulcer prevention program |
Primary outcome
Incidence of corneal ulceration in the two study arms as measured by corneal photography
Time frame: 3 years
1 secondary outcome
Trial-based cost effectiveness analysis to determine the incremental cost per corneal ulcer prevented
Time frame: 3 years
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 14 Sep 2026.
- Background: PubMed 30099393O'Brien KS, Byanju R, Kandel RP, Poudyal B, Gautam M, Gonzales JA, Porco TC, Whitcher JP, Srinivasan M, Upadhyay M, Lietman TM, Keenan JD; Village-Integrated Eye Worker Trial Group. Village-Integrated Eye Worker trial (VIEW): rationale and design of a cluster-randomised trial to prevent corneal ulcers in resource-limited settings. BMJ Open. 2018 Aug 10;8(8):e021556. doi: 10.1136/bmjopen-2018-021556.
- Results publication: PubMed 35303460O'Brien KS, Byanju R, Kandel RP, Poudyal B, Gonzales JA, Porco TC, Whitcher JP, Srinivasan M, Upadhyay M, Lietman TM, Keenan JD; Village-Integrated Eye Worker Trial Group. Village-integrated eye workers for prevention of corneal ulcers in Nepal (VIEW study): a cluster-randomised controlled trial. Lancet Glob Health. 2022 Apr;10(4):e501-e509. doi: 10.1016/S2214-109X(21)00596-9.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other investigators upon request after the conclusion of the study. 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. This study is not recruiting at the moment.
Tom M Lietman principal investigator
University of California San Francisco Proctor Foundation
Krisianne M Aromin study director
University of California San Francisco Proctor Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal ulcer prevention program in people with Corneal Ulcer, 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 3 inclusion and 4 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 14 Sep 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?
Incidence of corneal ulceration in the two study arms as measured by corneal photography (time frame: 3 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 NCT01969786, which also lists 2 linked publications.
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 14 Sep 2026.