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Village Integrated Eye Workers Trial (VIEW)

Primary Purpose

Corneal Ulcer

Status
Active
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Corneal ulcer prevention program
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Corneal Ulcer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bharatpur Eye Hospital - Seva Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Corneal ulcer prevention program

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of corneal ulceration in the two study arms as measured by corneal photography

Secondary Outcome Measures

Trial-based cost effectiveness analysis to determine the incremental cost per corneal ulcer prevented

Full Information

First Posted
October 21, 2013
Last Updated
June 28, 2023
Sponsor
University of California, San Francisco
Collaborators
National Eye Institute (NEI), Seva Foundation, Bharatpur Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01969786
Brief Title
Village Integrated Eye Workers Trial
Acronym
VIEW
Official Title
Village Integrated Eye Workers Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Eye Institute (NEI), Seva Foundation, Bharatpur Eye Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Ulcer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
223671 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corneal ulcer prevention program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Corneal ulcer prevention program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of corneal ulceration in the two study arms as measured by corneal photography
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Trial-based cost effectiveness analysis to determine the incremental cost per corneal ulcer prevented
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Incidence of corneal ulceration in the non-intervention arm corrected by passive surveillance
Time Frame
3 years
Title
Long-term follow-up of incidence of corneal ulceration in the two study arms as measured by corneal photography
Time Frame
5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom M Lietman
Organizational Affiliation
University of California San Francisco Proctor Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Krisianne M Aromin
Organizational Affiliation
University of California San Francisco Proctor Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Bharatpur Eye Hospital - Seva Foundation
City
Bharatpur
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Access Criteria
De-identified data will be available upon request.
Citations:
PubMed Identifier
30099393
Citation
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.
Results Reference
background
PubMed Identifier
35303460
Citation
O'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.
Results Reference
derived

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Village Integrated Eye Workers Trial

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