Vision In Preschoolers Study (VIP Study) - Tabular View

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Vision In Preschoolers Study (VIP Study)

This study is currently recruiting participants.
Information provided by National Eye Institute (NEI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Vision In Preschoolers Study (VIP Study)
Official Title ^†
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, and/or 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 and/or 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.
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Diagnostic
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Amblyopia Strabismus Refractive Error
Intervention ^†	Procedure: Vision Screening
MEDLINE PMIDs
Links	Vision In Preschoolers Study

Recruitment Information Fields
Recruitment Status ^†	Recruiting
Enrollment ^†
Start Date ^†
Completion Date
Eligibility Criteria ^†	Children enrolled in Head Start who are between the ages of 3 years 0 months and 4 years 11 months of age.
Gender	Both
Ages	36 Months to 59 Months
Accepts Healthy Volunteers	Yes
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00038753
Organization ID	NEI-85
Secondary IDs ^††
Study Sponsor ^†	National Eye Institute (NEI)
Collaborators ^††
Investigators ^†
Information Provided By	National Eye Institute (NEI)
Verification Date	May 2006
First Received Date ^†	June 4, 2002
Last Updated Date	May 26, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.