Ignite Creation Date:
2024-05-06 @ 10:29 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03278587
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2017-09-08
Brief Title:
Village-Integrated Eye Worker Trial II - Pilot
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Village-Integrated Eye Worker Trial II - Pilot
Status:
COMPLETED
Status Verified Date:
2022-12
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 Pilot
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
Worldwide eye health care systems must determine optimal strategies for reaching people outside of their immediate orbit in order to reduce visual impairment Visual impairment can be reduced by case detection of prevalent disease like cataract and refractive error or by screening for early disease like glaucoma AMD and DR and preventing progression Systems around the world have developed numerous approaches to both case detection and screening but there is very little research to support the choice of allocating resources to case detection or screening and little data exists on the cost effectiveness of the various approaches to each
VIEW II Pilot is a cluster-randomized trial to determine the effectiveness of different approaches to community-based case detection and screening for ocular disease Communities in Nepal will be randomized to one of four arms 1 a comprehensive ocular screening program 2 a cataract camp-based program 3 a community health worker-based program and 4 no program
Worldwide eye health care systems must determine optimal strategies for reaching people outside of their immediate orbit in order to reduce visual impairment Visual impairment can be reduced by case detection of prevalent disease like cataract and refractive error or by screening for early disease like glaucoma AMD and DR and preventing progression Systems around the world have developed numerous approaches to both case detection and screening but there is very little research to support the choice of allocating resources to case detection or screening and little data exists on the cost effectiveness of the various approaches to each
VIEW II Pilot is a cluster-randomized trial to determine the effectiveness of different approaches to community-based case detection and screening for ocular disease Communities in Nepal will be randomized to one of four arms 1 a comprehensive ocular screening program 2 a cataract camp-based program 3 a community health worker-based program and 4 no program
Detailed Description:
Specific Aim 1 to determine whether screening leads to increased visual acuity compared to the cataract camp approach
Specific Aim 2 to determine whether a community health volunteer program increases the rate of cataract surgery compared to a no program
Specific Aim 2 to determine whether a community health volunteer program increases the rate of cataract surgery compared to a no 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