Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038753
Status:
UNKNOWN
Last Update Posted:
2009-10-16
First Post:
2002-06-04
Brief Title:
Vision In Preschoolers Study VIP Study
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2009-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
To identify vision-screening tests that can accurately predict those three- and four-year old preschoolers who would benefit from a comprehensive vision examination because of signs of amblyopia strabismus andor significant refractive error
Detailed Description:
The Vision In Preschoolers VIP Study is a multi-center multidisciplinary prospective clinical study to evaluate screening tests for identifying preschool children in need of comprehensive eye examinations The primary goal of the VIP Study is to identify an effective and efficient battery of screening tests that has high sensitivity and specificity in identifying preschoolers in need of further evaluation for amblyopia strabismus andor significant refractive error
The VIP Study is designed in three-phases
Phase I activities will establish which screening tests perform well when administered by licensed eye care professionals pediatric optometrists and pediatric ophthalmologists in a population of 1000 Head Start preschoolers at high risk for the targeted vision disorders
Phase II activities will provide evaluation of the tests performance when administered by pediatric nurses and lay people on a high risk population of 1000 Head Start preschoolers Each child will be tested twice with each screening test - once by a pediatric nurse and once by a lay screener Tests selected for Phase II will be determined by the outcome of Phase I
Phase III activities will evaluate the performance of the tests in identifying individuals with specific vision disorders in a general population of 6400 Head Start preschoolers The category of screening personnel and the specific screening tests used in Phase III will be determined by the outcome of Phases I and II
The VIP Study is designed in three-phases
Phase I activities will establish which screening tests perform well when administered by licensed eye care professionals pediatric optometrists and pediatric ophthalmologists in a population of 1000 Head Start preschoolers at high risk for the targeted vision disorders
Phase II activities will provide evaluation of the tests performance when administered by pediatric nurses and lay people on a high risk population of 1000 Head Start preschoolers Each child will be tested twice with each screening test - once by a pediatric nurse and once by a lay screener Tests selected for Phase II will be determined by the outcome of Phase I
Phase III activities will evaluate the performance of the tests in identifying individuals with specific vision disorders in a general population of 6400 Head Start preschoolers The category of screening personnel and the specific screening tests used in Phase III will be determined by the outcome of Phases I and II
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None