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Vision In Preschoolers Study (VIP Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Eye Institute (NEI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00038753
First received: June 4, 2002
Last updated: October 15, 2009
Last verified: October 2009

June 4, 2002
October 15, 2009
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Complete list of historical versions of study NCT00038753 on ClinicalTrials.gov Archive Site
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Vision In Preschoolers Study (VIP Study)
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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.

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.

Interventional
Phase 3
Primary Purpose: Diagnostic
  • Amblyopia
  • Strabismus
  • Refractive Error
Procedure: Vision Screening
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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Children enrolled in Head Start who are between the ages of 3 years 0 months and 4 years 11 months of age.

Both
36 Months to 59 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038753
NEI-85
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National Eye Institute (NEI)
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National Eye Institute (NEI)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP