Vision In Preschoolers Study (VIP Study)

Amblyopia Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00038753
• Other study ID #: NEI-85
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 4, 2002
• Last updated: October 15, 2009

Study information

• Verified date: October 2009
• Source: National Eye Institute (NEI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 36 Months to 59 Months

Eligibility

Children enrolled in Head Start who are between the ages of 3 years 0 months and 4 years 11 months of age.

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Amblyopia
• Refractive Error
• Refractive Errors
• Strabismus

Intervention

Procedure:
• Vision Screening

Locations

Country	Name	City	State
United States	University of California, Berkeley School of Optometry	Berkeley	California
United States	New England College of Optometry	Boston	Massachusetts
United States	The Ohio State University College of Optometry	Columbus	Ohio
United States	Pennsylvania College of Optometry	Philadelphia	Pennsylvania
United States	Oklahoma Northeastern State University College of Optometry	Tahlequah	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States,