Vision In Preschoolers Study (VIP Study) - Full Text View

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 III

Genetics Home Reference related topics:

Eye Diseases

MedlinePlus related topics:

Refractive Errors

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038753

Locations


United States, California
	University of California, Berkeley School of Optometry	Recruiting
	Berkeley, California, United States, 94720-2020
	Contact: Deborah Orel-Bixler, PhD, OD 510-642-2402 dob@spectacle.berkeley.edu
	Principal Investigator: Deborah Orel-Bixler, PhD, OD

United States, Massachusetts
	New England College of Optometry	Recruiting
	Boston, Massachusetts, United States, 02215
	Contact: Bruce Moore, OD 617-236-6309 mooreb@ne-optometry.edu
	Principal Investigator: Bruce Moore, OD

United States, Ohio
	The Ohio State University College of Optometry	Recruiting
	Columbus, Ohio, United States, 43218-2342
	Contact: Paulette P Schmidt, OD, MS 614-292-3189 pschmidt@optometry.ohio-state.edu
	Principal Investigator: Paulette P Schmidt, OD, MS

United States, Oklahoma
	Oklahoma Northeastern State University College of Optometry	Recruiting
	Tahlequah, Oklahoma, United States, 74464
	Contact: Lynn Cyert, OD, PhD 918-456-5511 ext 4007 cyert@nsuok.edu
	Principal Investigator: Lynn Cyert, PhD, OD

United States, Pennsylvania
	Pennsylvania College of Optometry	Recruiting
	Philadelphia, Pennsylvania, United States, 19141
	Contact: Elise Ciner, OD 215-276-6059 Eciner@pco.edu
	Principal Investigator: Elise Ciner, OD

Sponsors and Collaborators

National Eye Institute (NEI)

More Information

Vision In Preschoolers Study This link exits the ClinicalTrials.gov site

Study ID Numbers:	NEI-85
First Received:	June 4, 2002
Last Updated:	May 26, 2006
ClinicalTrials.gov Identifier:	NCT00038753
Health Authority:	United States: Federal Government

Keywords provided by National Eye Institute (NEI):

vision screening

Study placed in the following topic categories:

Ocular Motility Disorders

Sensation Disorders

Motor neuro-ophthalmic disorders

Vision Disorders

Amblyopia

Strabismus

Neurologic Manifestations

Central Nervous System Diseases

Brain Diseases

Ocular motility disorders

Refractive Errors

Additional relevant MeSH terms:

Signs and Symptoms

Eye Diseases

Nervous System Diseases

Cranial Nerve Diseases

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00038753