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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Age Related Macular Degeneration
Refractive Errors
Cataract
Glaucoma
Diabetic Retinopathy

Treatments

Other: Community health worker program
Other: Cataract camp program
Other: Community-based screening program

Study type

Interventional

Funder types

Other

Identifiers

NCT03278587
17-22776

Details and patient eligibility

About

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.

Full 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.

Enrollment

16,075 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

16,075 participants in 4 patient groups

Community-based screening
Active Comparator group
Treatment:
Other: Community-based screening program
Cataract camp program
Active Comparator group
Treatment:
Other: Cataract camp program
Community health worker program
Active Comparator group
Treatment:
Other: Community health worker program
No intervention
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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