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Vision In Preschoolers Study (VIP Study)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by National Eye Institute (NEI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00038753
First Posted: June 5, 2002
Last Update Posted: October 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Eye Institute (NEI)
  Purpose
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.

Condition Intervention Phase
Amblyopia Strabismus Refractive Error Procedure: Vision Screening Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Children enrolled in Head Start who are between the ages of 3 years 0 months and 4 years 11 months of age.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038753


Locations
United States, California
University of California, Berkeley School of Optometry
Berkeley, California, United States, 94720-2020
United States, Massachusetts
New England College of Optometry
Boston, Massachusetts, United States, 02215
United States, Ohio
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43218-2342
United States, Oklahoma
Oklahoma Northeastern State University College of Optometry
Tahlequah, Oklahoma, United States, 74464
United States, Pennsylvania
Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
National Eye Institute (NEI)
  More Information

ClinicalTrials.gov Identifier: NCT00038753     History of Changes
Other Study ID Numbers: NEI-85
First Submitted: June 4, 2002
First Posted: June 5, 2002
Last Update Posted: October 16, 2009
Last Verified: October 2009

Keywords provided by National Eye Institute (NEI):
vision screening

Additional relevant MeSH terms:
Amblyopia
Refractive Errors
Strabismus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases