Ignite Creation Date:
2024-05-06 @ 12:24 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03752840
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2018-11-16
Brief Title:
Village-Integrated Eye Worker Trial II
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Village-Integrated Eye Worker Trial II VIEW IIA Cluster-randomized Trial of the Effectiveness of Community-based Ocular Disease Screening in Nepal
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIEW II
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 progressionThus community screening programs may prevent progression and improve the vision of a populationHowever 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 mobileeasy-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
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 progressionThus community screening programs may prevent progression and improve the vision of a populationHowever 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 mobileeasy-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
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 2060 Metric Snellen worse than 618 logMAR worse than 048 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None