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Village Integrated Eye Workers Trial (VIEW)

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ClinicalTrials.gov Identifier: NCT01969786
Recruitment Status : Recruiting
First Posted : October 25, 2013
Last Update Posted : January 15, 2021
Sponsor:
Collaborators:
National Eye Institute (NEI)
Seva Foundation
Bharatpur Eye Hospital
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Corneal Ulcer Other: Corneal ulcer prevention program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Village Integrated Eye Workers Trial
Study Start Date : February 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Corneal ulcer prevention program
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.
Other: Corneal ulcer prevention program
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.

No Intervention: Control
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.



Primary Outcome Measures :
  1. Incidence of corneal ulceration in the two study arms as measured by corneal photography [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Trial-based cost effectiveness analysis to determine the incremental cost per corneal ulcer prevented [ Time Frame: 3 years ]

Other Outcome Measures:
  1. Incidence of corneal ulceration in the non-intervention arm corrected by passive surveillance [ Time Frame: 3 years ]
  2. Long-term follow-up of incidence of corneal ulceration in the two study arms as measured by corneal photography [ Time Frame: 5 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of a corneal abrasion
  • Willingness to be treated with topical antibiotic and antifungal ointments 3 times a day for 3 days
  • Appropriate consent

Exclusion Criteria:

  • Evidence of a corneal ulcer
  • Evidence of other acute eye disease requiring urgent care
  • Known allergy to study medications
  • Not willing to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969786


Contacts
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Contact: Tom M Lietman 4155142163 tom.lietman@ucsf.edu

Locations
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Nepal
Bharatpur Eye Hospital - Seva Foundation Recruiting
Bharatpur, Nepal
Contact: Ram P Kandel       seva.kandel@lei.org.np   
Principal Investigator: Ram P Kandel         
Sponsors and Collaborators
University of California, San Francisco
National Eye Institute (NEI)
Seva Foundation
Bharatpur Eye Hospital
Investigators
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Principal Investigator: Tom M Lietman University of California San Francisco Proctor Foundation
Study Director: Kieran S O'Brien University of California San Francisco Proctor Foundation
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01969786    
Other Study ID Numbers: U10EY02280
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.
Additional relevant MeSH terms:
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Corneal Ulcer
Eye Infections
Infection
Keratitis
Corneal Diseases
Eye Diseases