Village-Integrated Eye Worker Trial II

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    60000
  • sponsor
    Francis I. Proctor Foundation
Updated on 28 March 2021
angiography
cataract
blindness
retinopathy
diabetic retinopathy
visual impairment
glaucoma
fundus photography
optical coherence tomography
brimonidine tartrate ophthalmic solution
refractive error
intraocular pressure
visual loss
eye disease
age-related macular degeneration
macular degeneration
eye disorder

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.

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.

Details
Condition Ocular Hypertension, Glaucoma, age-related macular degeneration, Diabetic Retinopathy, Diabetic Macular Edema, Macular Degeneration
Treatment Optical Coherence Tomography (OCT), Visual acuity (presenting and pinhole), Intraocular pressure, Intraocular pressure, Active linkage to care
Clinical Study IdentifierNCT03752840
SponsorFrancis I. Proctor Foundation
Last Modified on28 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 60 yrs?
Gender: Male or Female
Do you have any of these conditions: Macular Degeneration or Diabetic Macular Edema or Glaucoma or Ocular Hypertension or age-related macular degeneration or Diabetic Retinopathy?
Do you have any of these conditions: Diabetic Macular Edema or age-related macular degeneration or Diabetic Retinopathy or Macular Degeneration or Glaucoma or Ocular Hypertension?
Do you have any of these conditions: Macular Degeneration or age-related macular degeneration or Diabetic Retinopathy or Diabetic Macular Edema or Glaucoma or Ocular Hypertension?
Do you have any of these conditions: Diabetic Retinopathy or Macular Degeneration or Glaucoma or Ocular Hypertension or age-related macular degeneration or Diabetic Macular Edema?
years or older
Residing in the community during the time of the census

Exclusion Criteria

Unwilling to participate
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