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

Overview

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 cases early 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 predisposed to 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 approaches to these identification methods, including screening using telemedicine and case detection via cataract camps or 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, mass 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 regional 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 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 mobile screening programs. The investigators propose a large cluster-randomized trial to compare two population level 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 clusters 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.

Interventions

• 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.
• Other Fundus Photography
  Fundus cameras will be used to image the macula and optic nerve. The images will be assessed for abnormalities and participants meeting referral criteria will be referred to the local eye hospital.

Primary outcome measures

• Pinhole visual acuity (logMAR) in people aged 60 years and older [Time frame: 9 years]

Secondary outcome measures (4)

• Incidence of visual impairment due to AMD, DR, or glaucoma [Time frame: 9 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 [Time frame: 9 years]
• Presenting visual acuity (logMAR) in people aged 60 years and older [Time frame: 9 years]
• Cost-effectiveness of the screening intervention [Time frame: 9 years]

Eligibility criteria

Community level

Inclusion criteria

• Located in catchment area of Bharatpur Eye Hospital or Lumbini Eye Institute
• Reachable 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Screening

Study locations

United States · 1 center

• University of California, San Francisco — San Francisco

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. PMID 33060092

Identifiers

NCT: NCT03752840 · 17-22776-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗