Vision In Preschoolers Study (VIP Study)
Recruitment status was Active, not recruiting
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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 |
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 |
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| 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 | |
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:
|
Amblyopia Refractive Errors Strabismus Brain Diseases Central Nervous System Diseases Nervous System Diseases Vision Disorders |
Sensation Disorders Neurologic Manifestations Eye Diseases Signs and Symptoms Ocular Motility Disorders Cranial Nerve Diseases |
ClinicalTrials.gov processed this record on May 23, 2013