Village-Integrated Eye Worker Trial II (VIEW II)

Village-Integrated Eye Worker Trial II (VIEW II):A Cluster-randomized Trial of the Effectiveness of Community-based Ocular Disease Screening in Nepal

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.

To address the global burden of avoidable blindness, eye care systems must determine optimal strategies for identifying people with or at risk for visual impairment beyond opportunistic screening. Outreach programs can prevent blindness both by screening for asymptomatic disease like age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma and case detection of symptomatic disease like cataract and refractive error. Eye care systems have developed numerous community-based approaches to these identification methods, including screening using telemedicine and case detection via cataract camps or community health worker models, but no studies have been conducted on the comparative effectiveness or cost effectiveness of these various approaches.

Technology promises to greatly improve access to sophisticated eye care. AMD, DR, and glaucoma can result in irreversible vision loss, and early diagnosis and effective treatment can prevent progression.Thus, community screening programs may prevent progression and improve the vision of a population.However, mass screening for eye disease is currently not recommended. Although self-evident that early detection can prevent blindness for an individual, no randomized controlled trial has been able to demonstrate that screening improves visual acuity at the community level. However, recent technological advances promise to dramatically change the equation by allowing non-medical personnel to use mobile,easy-to-use retinal imaging devices to diagnose screenable eye diseases such as AMD, DR, and glaucoma. Mobile technology could also transform the way clinics communicate with their patients, improving linkage to and retention in care.

Optical coherence tomography (OCT) is an ideal test for community-based screening. OCT can be performed through an undilated pupil and is less subject to optical aberrations due to cataract than is fundus photography. OCT machines have pre-installed algorithms to screen for glaucoma, and major anatomical abnormalities can easily be detected even by novice technicians. The infrared image allows detection of referable diabetic retinopathy, and newer OCT angiography machines offer even more discrimination of early diabetic retinopathy. OCT machines are ever more portable, and could be feasibly used in community-based screening programs.

The investigators propose a large cluster-randomized trial in Nepal to compare two community-based blindness prevention programs: (1) a state-of-the-art screening program employing OCT and intraocular pressure testing to screen for glaucoma, DR, and AMD followed by enhanced linkage-to-care to the local eye hospital, and (2) a screening program involving only visual acuity assessment. An initial door-to-door census will assess baseline visual acuity in both study arms. The investigators will compare visual acuity between the two arms through a second door-to-door census 4 years later (primary outcome). The investigators maximize their chances of finding an effect by conducting the study in Nepal, where the burden of undiagnosed eye diseases is high. If successful in Nepal, future studies could assess the generalizability of such a program to other settings, such as rural communities in the industrialized world.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Diabetic Retinopathy; Age-related Macular Degeneration
• Intervention / Treatment: Other: Visual acuity (presenting and pinhole); Other: Optical coherence tomography (OCT); Other: Intraocular pressure; Other: Active linkage to care

Detailed Description

The research will consist of a large cluster-randomized trial in Nepal in which all communities receive visual acuity screening during a baseline census, and then half subsequently receive screening with OCT and intraocular pressure testing with an iCare tonometer. Participants with abnormal results will be referred to the local eye hospital for examination and treatment. Repeat visual acuity assessment will be performed 4 years later. Those with incident visual impairment at the time of the final census, defined as visual acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48), will receive a comprehensive eye exam to determine the cause of visual impairment.

Specific Aim 1 - Visual Acuity: To determine whether an intensive screening program results in better visual acuity at 4 years than screening with visual acuity testing alone. The investigators hypothesize that individuals from clusters randomized to the intensive screening program will have better visual acuity compared to those receiving visual acuity testing alone.

Specific Aim 2 - Eye Disease: To determine whether an intensive screening program reduces the incidence of visual impairment due to AMD, DR, or glaucoma. The investigators hypothesize that incident visual impairment due to AMD, DR, or glaucoma will be less common in clusters randomized to the intensive screening program.

• Study Type: Interventional
• Enrollment (Estimated): 60000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Krisianne M Aromin, BS; Phone Number: 4154761442; Email: krisianne.aromin@ucsf.edu

Study Locations

• Nepal
  • Bhairahawa, Nepal
    • Not yet recruiting
    • Lumbini Eye Institute
    • Contact: Salma Rai
  • Chitwan
    • Bharatpur, Chitwan, Nepal
      • Recruiting
      • Bharatpur Eye Hospital
      • Contact: Raghunandan Byanju

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Community level

Inclusion Criteria:

• Located in catchment area of Bharatpur Eye Hospital or Lumbini Eye Institute
• Accessible by non-4WD vehicle
• Urban or peri-urban

Exclusion Criteria:

- Local leaders unwilling to participate

Person level

Inclusion Criteria:

• 60 years and older
• Residing in the community during the time of the census

Exclusion Criteria:

- Unwilling to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening	Other: Visual acuity (presenting and pinhole); Presenting and pinhole visual acuity will be assessed using the Peek Acuity mobile application. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital.; Other: Optical coherence tomography (OCT); OCT will be used to image the anterior segment, the macula, and the retinal nerve fiber layer. The images will be assessed for abnormalities and participants meeting referral criteria will be referred to the local eye hospital.; Other: Intraocular pressure; Intraocular pressure will be measured using an iCare tonometer. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital.; Other: Active linkage to care; Referred participants will be followed closely by study staff to ensure completion of follow-up visits.
Active Comparator: Case detection	Other: Visual acuity (presenting and pinhole); Presenting and pinhole visual acuity will be assessed using the Peek Acuity mobile application. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pinhole visual acuity (logMAR) in people aged 60 years and older	Visual acuity will be assessed using the Peek Acuity mobile application during the final census.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of visual impairment due to AMD, DR, or glaucoma	Participants with incident visual impairment, defined as Snellen worse than 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48), at the time of the final census will receive a comprehensive eye exam to determine the cause of visual impairment	4 years
Bilateral blindness in people aged 60 years and older, defined as pinhole visual acuity worse than Snellen 20/400 (Metric Snellen worse than 6/120; logMAR worse than 1.3) in the better-seeing eye	Visual acuity will be assessed using the Peek Acuity mobile application during the final census.	4 years
Presenting visual acuity (logMAR) in people aged 60 years and older	Visual acuity will be assessed using the Peek Acuity mobile application during the final census.	4 years
Cost-effectiveness of the screening intervention	Costs associated with the screening intervention will be actively recorded during the study period and number of cases of AMD, DR, and glaucoma diagnosed and visual acuity as assessed with Peek Acuity during the final census will be used to evaluate effectiveness.	4 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bilateral visual impairment in people aged 60 years and older, defined as pinhole visual acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48) in the better-seeing eye	Visual acuity will be assessed using the Peek Acuity mobile application during the final census.	4 years
Bilateral presenting visual impairment in people aged 60 years and older, defined as presenting visual acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48) in the better-seeing eye	Visual acuity will be assessed using the Peek Acuity mobile application during the final census.	4 years
Bilateral presenting blindness in people aged 60 years and older, defined as presenting visual acuity worse than Snellen 20/400 (Metric Snellen worse than 6/120; logMAR worse than 1.3) in the better-seeing eye	Visual acuity will be assessed using the Peek Acuity mobile application during the final census.	4 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Seva Foundation; Bharatpur Eye Hospital; Lumbini Eye Institute and Hospital
• Investigators: Principal Investigator: Jeremy Keenan, University of California, San Francisco

Publications and helpful links

General Publications

• O'Brien KS, Stevens VM, Byanju R, Kandel RP, Bhandari G, Bhandari S, Melo JS, Porco TC, Lietman TM, Keenan JD; Group Information for the VIEW II Study Group. Cluster-randomised trial of community-based screening for eye disease in adults in Nepal: the Village-Integrated Eye Worker Trial II (VIEW II) trial protocol. BMJ Open. 2020 Oct 15;10(10):e040219. doi: 10.1136/bmjopen-2020-040219.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2019
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Diabetic Retinopathy
• Other Study ID Numbers: 17-22776-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared with other investigators upon request after the conclusion of the study. A request form will be available on Open Science Framework (https://osf.io/fgvrt/); all requests will be approved by the executive committee of the trial before sharing data. GPS data will not be shared.
• IPD Sharing Time Frame: De-identified data will be shared after publication of the major findings of the study, which we anticipate will occur around 6 months after the study conclusion.
• IPD Sharing Access Criteria: De-identified data will be available upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No