Clinical trial NCT03752840: Village-Integrated Eye Worker Trial II
Official title: Village-Integrated Eye Worker Trial II (VIEW II):A Cluster-randomized Trial of the Effectiveness of Community-based Ocular Disease Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age-related Macular Degeneration
Diabetic Retinopathy
Glaucoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Seva Foundation
First posted: 2018-11-26
Enrollment: 60200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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, fundus photography, 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 9 years later (primary outcome).

Detailed description: The research will consist of a large cluster-randomized trial in which all communities receive visual acuity screening during a baseline census, and then half subsequently receive screening with OCT, fundus photography, 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 9 years later. Those with 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 9 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.

Eligibility criteria: 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:

* 50 years and older
* Residing in the community during the time of the census

Exclusion Criteria:

- Unwilling to participate

Primary outcomes:
measure: Pinhole visual acuity (logMAR) in people aged 50 years and older
timeFrame: 9 years
Secondary outcomes:
measure: Incidence of visual impairment due to AMD, DR, or glaucoma
timeFrame: 9 years
measure: Bilateral blindness in people aged 50 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
timeFrame: 9 years
measure: Presenting visual acuity (logMAR) in people aged 50 years and older
timeFrame: 9 years
measure: Cost-effectiveness of the screening intervention
timeFrame: 9 years
Other outcomes:
measure: Bilateral visual impairment in people aged 50 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
timeFrame: 9 years
measure: Bilateral presenting visual impairment in people aged 50 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
timeFrame: 9 years
measure: Bilateral presenting blindness in people aged 50 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
timeFrame: 9 years
Locations:
city: Bharatpur
country: Nepal
facility: Bharatpur Eye Hospital
state: Chitwan
Study officials:
affiliation: University of California, San Francisco
name: Jeremy Keenan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.