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Village-Integrated Eye Worker Trial II - Pilot (VIEW II Pilot)

Primary Purpose

Cataract, Glaucoma, Age Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Community-based screening program
Cataract camp program
Community health worker 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 Cataract

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria(community-level):

  • 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.

Inclusion Criteria (individual-level):

  • Individuals aged 50 and older will be eligible to participate in the screening program, cataract camp programs, and the FCHV program

Sites / Locations

  • Bharatpur Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Community-based screening

Cataract camp program

Community health worker program

No intervention

Arm Description

Outcomes

Primary Outcome Measures

Visual acuity
Primary outcome for specific aim 1, comparison between screening and case detection arms
Cataract surgical rate
Primary outcome for specific aim 2, comparison between community health worker program and no program arms

Secondary Outcome Measures

Cost-effectiveness
Cost-effectiveness of all 4 arms will be assessed
Visual acuity
Visual acuity of population 50 years and older in all arms will be compared
Number of cases of ocular disease detected
Number of cases of ocular disease in the screening and case detection arms will be compared

Full Information

First Posted
September 8, 2017
Last Updated
December 15, 2022
Sponsor
University of California, San Francisco
Collaborators
Seva Foundation, Bharatpur Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03278587
Brief Title
Village-Integrated Eye Worker Trial II - Pilot
Acronym
VIEW II Pilot
Official Title
Village-Integrated Eye Worker Trial II - Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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. Worldwide, 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 in Nepal 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Glaucoma, Age Related Macular Degeneration, Diabetic Retinopathy, Refractive Errors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16075 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community-based screening
Arm Type
Active Comparator
Arm Title
Cataract camp program
Arm Type
Active Comparator
Arm Title
Community health worker program
Arm Type
Active Comparator
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Community-based screening program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cataract camp program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Community health worker program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual acuity
Description
Primary outcome for specific aim 1, comparison between screening and case detection arms
Time Frame
1 year
Title
Cataract surgical rate
Description
Primary outcome for specific aim 2, comparison between community health worker program and no program arms
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Description
Cost-effectiveness of all 4 arms will be assessed
Time Frame
1 year
Title
Visual acuity
Description
Visual acuity of population 50 years and older in all arms will be compared
Time Frame
1 year
Title
Number of cases of ocular disease detected
Description
Number of cases of ocular disease in the screening and case detection arms will be compared
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria(community-level): 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. Inclusion Criteria (individual-level): Individuals aged 50 and older will be eligible to participate in the screening program, cataract camp programs, and the FCHV program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy D Keenan, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bharatpur Eye Hospital
City
Bharatpur
State/Province
Chitwan
Country
Nepal

12. IPD Sharing Statement

Learn more about this trial

Village-Integrated Eye Worker Trial II - Pilot

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