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Village-Integrated Eye Worker Trial II (VIEW II)

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ClinicalTrials.gov Identifier: NCT03752840
Recruitment Status : Not yet recruiting
First Posted : November 26, 2018
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
Seva Foundation
Bharatpur Eye Hospital
Lumbini Eye Institute and 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.

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.


Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Diabetic Retinopathy Glaucoma Other: Visual acuity (presenting and pinhole) Other: Optical coherence tomography (OCT) Other: Intraocular pressure Other: Active linkage to care Not Applicable

Detailed Description:

The research will consist of a large cluster-randomized trial in Nepal in which all communities receive visual acuity screening by community health workers, 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.

Specific Aim 1 - Visual Acuity: To determine whether the intensive screening program reduces visual impairment relative to a program involving only visual acuity assessment. The investigators hypothesize that communities randomized to the intensive screening program will have better presenting visual acuity at 4 years compared to those randomized to case detection via visual acuity assessment alone.

Specific Aim 2 - Eye Disease: To determine whether an intensive screening program detects more screen-able eye disease than a screening program involving visual acuity assessment alone. The investigators hypothesize that the number of cases of AMD, DR, and glaucoma will be higher in communities randomized to the intensive screening program than in those receiving visual acuity screening only.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Village-Integrated Eye Worker Trial II (VIEW II):A Cluster-randomized Trial of the Effectiveness of Community-based Ocular Disease Screening in Nepal
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Visual acuity (logMAR) in people aged 60 years and older [ Time Frame: 4 years ]
    Visual acuity will be assessed using the Peek Acuity mobile application during the final census.


Secondary Outcome Measures :
  1. Number of cases of glaucoma, DR, and AMD per randomization unit seen at the study [ Time Frame: 4 years ]
    Cases of glaucoma, DR, and AMD in people aged 60 years and older will be extracted from each hospital's electronic medical record

  2. Bilateral visual impairment in people aged 60 years and older, defined as Snellen worse than 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.477) in the better-seeing eye [ Time Frame: 4 years ]
    Visual acuity will be assessed using the Peek Acuity mobile application during the final census.

  3. Bilateral blindness in people aged 60 years and older, defined as Snellen worse than 20/400 (Metric Snellen worse than 6/120; logMAR worse than 1.3) in the better-seeing eye [ Time Frame: 4 years ]
    Visual acuity will be assessed using the Peek Acuity mobile application during the final census.

  4. Number of cataract surgeries performed per randomization unit at the study hospitals [ Time Frame: Surgery in the time from screening through 4 years after screening ]
    Cataract surgeries performed during the study period will be extracted from each hospital's electronic medical record.

  5. Cost-effectiveness of the screening intervention [ Time Frame: 4 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

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

Exclusion Criteria:

- Unwilling to participate


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): NCT03752840


Contacts
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Contact: Kieran S O'Brien 4155142163 kieran.obrien@ucsf.edu

Locations
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Nepal
Bharatpur Eye Hospital Not yet recruiting
Bharatpur, Chitwan, Nepal
Contact: Raghunandan Byanju         
Lumbini Eye Institute Not yet recruiting
Bhairahawa, Nepal
Contact: Salma Rai         
Sponsors and Collaborators
Francis I. Proctor Foundation
Seva Foundation
Bharatpur Eye Hospital
Lumbini Eye Institute and Hospital
Investigators
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Principal Investigator: Jeremy Keenan Francis I. Proctor Foundation

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Responsible Party: Jeremy Keenan, Professor, Francis I. Proctor Foundation
ClinicalTrials.gov Identifier: NCT03752840     History of Changes
Other Study ID Numbers: 17-22776-2
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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