Village-Integrated Eye Worker Trial II - Pilot

Not Applicable

Completed

• Conditions: Diabetic Retinopathy; Refractive Errors; Glaucoma; Cataract; Age Related Macular Degeneration
• Interventions: Other: Community-based screening program; Other: Cataract camp program; Other: Community health worker program

• Registration Number: NCT03278587
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Study Start: 2018-05-31
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16075

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community-based screening	Community-based screening program	-
Cataract camp program	Cataract camp program	-
Community health worker program	Community health worker program	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	1 year	Cost-effectiveness of all 4 arms will be assessed
Visual acuity	1 year	Visual acuity of population 50 years and older in all arms will be compared
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

Trial Locations

Locations (1)

Bharatpur Eye Hospital; 🇳🇵 Bharatpur, Chitwan, Nepal