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Vision In Preschoolers Study (VIP Study)

Primary Purpose

Amblyopia, Strabismus, Refractive Error

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vision Screening
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amblyopia focused on measuring vision screening

Eligibility Criteria

36 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, Berkeley School of Optometry
  • New England College of Optometry
  • The Ohio State University College of Optometry
  • Oklahoma Northeastern State University College of Optometry
  • Pennsylvania College of Optometry

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 4, 2002
Last Updated
October 15, 2009
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00038753
Brief Title
Vision In Preschoolers Study (VIP Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia, Strabismus, Refractive Error
Keywords
vision screening

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Vision Screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Children enrolled in Head Start who are between the ages of 3 years 0 months and 4 years 11 months of age.
Facility Information:
Facility Name
University of California, Berkeley School of Optometry
City
Berkeley
State/Province
California
ZIP/Postal Code
94720-2020
Country
United States
Facility Name
New England College of Optometry
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
The Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43218-2342
Country
United States
Facility Name
Oklahoma Northeastern State University College of Optometry
City
Tahlequah
State/Province
Oklahoma
ZIP/Postal Code
74464
Country
United States
Facility Name
Pennsylvania College of Optometry
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States

12. IPD Sharing Statement

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Vision In Preschoolers Study (VIP Study)

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