ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 107 for:    ( Map: Nepal )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03278587
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : June 19, 2018
Sponsor:
Collaborators:
Seva Foundation
Bharatpur Eye Hospital
Information provided by (Responsible Party):
Jeremy Keenan, Francis I. Proctor Foundation

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.


Condition or disease Intervention/treatment Phase
Cataract Glaucoma Age Related Macular Degeneration Diabetic Retinopathy Refractive Errors Other: Community-based screening program Other: Cataract camp program Other: Community health worker program Not Applicable

Detailed Description:

Specific Aim 1: to determine whether screening detects more cases of glaucoma, DR, and AMD 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Village-Integrated Eye Worker Trial II - Pilot
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: Community-based screening 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.

Active Comparator: Cataract camp program Other: 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.

Active Comparator: Community health worker program Other: 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.

No Intervention: No intervention



Primary Outcome Measures :
  1. Number of cases of ocular disease detected [ 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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278587


Contacts
Contact: Kieran S O'Brien, MPH 415-514-2163 kieran.obrien@ucsf.edu

Locations
Nepal
Bharatpur Eye Hospital Recruiting
Bharatpur, Chitwan, Nepal
Contact: Byanju Raghunandan       raghunandanbyanju@gmail.com   
Sponsors and Collaborators
Francis I. Proctor Foundation
Seva Foundation
Bharatpur Eye Hospital
Investigators
Principal Investigator: Jeremy D Keenan, MD, MPH Francis I. Proctor Foundation, University of California, San Francisco

Responsible Party: Jeremy Keenan, Director, International Programs; Associate Professor, Francis I. Proctor Foundation
ClinicalTrials.gov Identifier: NCT03278587     History of Changes
Other Study ID Numbers: 17-22776
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Cataract
Diabetic Retinopathy
Refractive Errors
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lens Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases