Clinical trial NCT03278587: Village-Integrated Eye Worker Trial II - Pilot
Official title: Village-Integrated Eye Worker Trial II - Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Glaucoma
Age Related Macular Degeneration
Diabetic Retinopathy
Refractive Errors
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Seva Foundation
name: Bharatpur Eye Hospital
First posted: 2017-09-11
Enrollment: 16075
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Visual acuity
timeFrame: 1 year
measure: Cataract surgical rate
timeFrame: 1 year
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 1 year
measure: Visual acuity
timeFrame: 1 year
measure: Number of cases of ocular disease detected
timeFrame: 1 year
Other outcomes:
Locations:
city: Bharatpur
country: Nepal
facility: Bharatpur Eye Hospital
state: Chitwan
Study officials:
affiliation: University of California, San Francisco
name: Jeremy D Keenan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: