Village-Integrated Eye Worker Trial II - Pilot

Cataract Clinical Trial

— VIEW II Pilot  

Official title:

Village-Integrated Eye Worker Trial II - Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278587
• Other study ID #: 17-22776
• Status: Completed
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: December 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16075
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Cataract
• Diabetic Retinopathy
• Glaucoma
• Macular Degeneration
• Refractive Errors

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Nepal	Bharatpur Eye Hospital	Bharatpur	Chitwan

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Bharatpur Eye Hospital, Seva Foundation

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Primary outcome for specific aim 1, comparison between screening and case detection arms	1 year
Primary	Cataract surgical rate	Primary outcome for specific aim 2, comparison between community health worker program and no program arms	1 year
Secondary	Cost-effectiveness	Cost-effectiveness of all 4 arms will be assessed	1 year
Secondary	Visual acuity	Visual acuity of population 50 years and older in all arms will be compared	1 year
Secondary	Number of cases of ocular disease detected	Number of cases of ocular disease in the screening and case detection arms will be compared	1 year