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
  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

Ages Eligible for Study:   36 Months to 59 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00038753     History of Changes
Other Study ID Numbers: NEI-85
Study First Received: June 4, 2002
Last Updated: October 15, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Refractive Errors
Strabismus
Cranial Nerve Diseases
Eye Diseases
Nervous System Diseases
Ocular Motility Disorders

ClinicalTrials.gov processed this record on October 23, 2014