VIEW II Pilot: Village-Integrated Eye Worker Trial II - Pilot

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT03278587
Collaborator
Seva Foundation (Other), Bharatpur Eye Hospital (Other)
15,000
Enrollment
1
Location
4
Arms
54
Anticipated Duration (Months)
277.5
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Community-based screening program
  • Other: Cataract camp program
  • Other: Community health worker program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Village-Integrated Eye Worker Trial II - Pilot
Actual Study Start Date :
May 31, 2018
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Community-based screening

Other: Community-based screening program
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.

Active Comparator: Cataract camp program

Other: Cataract camp program
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.

Active Comparator: Community health worker program

Other: Community health worker program
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.

No Intervention: No intervention

Outcome Measures

Primary Outcome Measures

  1. Visual acuity [1 year]

    Primary outcome for specific aim 1, comparison between screening and case detection arms

  2. Cataract surgical rate [1 year]

    Primary outcome for specific aim 2, comparison between community health worker program and no program arms

Secondary Outcome Measures

  1. Cost-effectiveness [1 year]

    Cost-effectiveness of all 4 arms will be assessed

  2. Visual acuity [1 year]

    Visual acuity of population 50 years and older in all arms will be compared

  3. Number of cases of ocular disease detected [1 year]

    Number of cases of ocular disease in the screening and case detection arms will be compared

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Bharatpur Eye HospitalBharatpurChitwanNepal

Sponsors and Collaborators

  • University of California, San Francisco
  • Seva Foundation
  • Bharatpur Eye Hospital

Investigators

  • Principal Investigator: Jeremy D Keenan, MD, MPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT03278587
Other Study ID Numbers:
  • 17-22776
First Posted:
Sep 11, 2017
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021