Skip to main content
OpenTrials
Completed

NCT Number: NCT03278587

Village-Integrated Eye Worker Trial II - Pilot

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.

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Age Related Macular Degeneration Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glaucoma Lens Diseases Macular Degeneration Ocular Hypertension Refractive Errors Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bharatpur Eye Hospital

Bharatpur, Chitwan, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community-based screening program

Other

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.

Cataract camp program

Other

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.

Community health worker program

Other

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 outcomes

  1. Visual acuity

    Time frame: 1 year

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

  2. Cataract surgical rate

    Time frame: 1 year

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

Secondary outcomes

  1. Cost-effectiveness

    Time frame: 1 year

    Cost-effectiveness of all 4 arms will be assessed

  2. Visual acuity

    Time frame: 1 year

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

  3. Number of cases of ocular disease detected

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Seva Foundation

Registry information

Acronym: VIEW II Pilot

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 11, 2017
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.