- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00038753
Vision In Preschoolers Study (VIP Study)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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California
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Berkeley, California, Forenede Stater, 94720-2020
- University of California, Berkeley School of Optometry
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- New England College of Optometry
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Ohio
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Columbus, Ohio, Forenede Stater, 43218-2342
- The Ohio State University College of Optometry
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Oklahoma
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Tahlequah, Oklahoma, Forenede Stater, 74464
- Oklahoma Northeastern State University College of Optometry
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19141
- Pennsylvania College of Optometry
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NEI-85
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