Vision In Preschoolers Study (VIP Study)

NCT ID: NCT00038753

Last Updated: 2009-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Amblyopia Strabismus Refractive Error

Study Design

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Primary Study Purpose

DIAGNOSTIC

Interventions

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Vision Screening

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

36 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role lead

Locations

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University of California, Berkeley School of Optometry

Berkeley, California, United States

Site Status

New England College of Optometry

Boston, Massachusetts, United States

Site Status

The Ohio State University College of Optometry

Columbus, Ohio, United States

Site Status

Oklahoma Northeastern State University College of Optometry

Tahlequah, Oklahoma, United States

Site Status

Pennsylvania College of Optometry

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NEI-85

Identifier Type: -

Identifier Source: org_study_id

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