- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02157025
Una prueba de campo visual más atractiva para aumentar el uso y la confiabilidad en pediatría
The majority of young children do not think that visual field (VF) testing of peripheral vision is similar to a game; therefore, it is not surprising that they have difficulty maintaining attention during VF testing and thus the test reliability suffers as a consequence. Poor VF reliability has been a longstanding, major issue since it leads to an increased number of tests and/or longer duration of time needed to determine when there are true vision losses. Providers are less likely to obtain VF tests in children since the results are of doubtful value and challenging to interpret when they are inconsistent. Effectively this means that children with untreated, slowly progressive eye diseases may go undiagnosed and incur greater visual losses. The investigators aim to create a prototype device that the investigators hypothesize will make VF testing more engaging for young children, thus increasing their attention and consistency of their responses to the test stimuli, which in turn should improve VF reliability. The components include a microdisplay video screen (1.5" diameter) as the fixation target (instead of the standard LED light) displaying video clips of popular cartoon characters, and audio clips of impersonated cartoon character voices presented by the test operator to provide instructional feedback based on the child's performance during testing. Improved VF reliability from the investigators intervention would translate to improved diagnosis and care for young childrens' peripheral vision loss through widespread implementation of the investigators innovative, affordable and readily adoptable system at eye care providers' offices.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33328
- The Eye Care Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Ages 5-8
- Seen previously in the clinics at Nova Southeastern University's The Eye Care Institute with a diagnosis for glaucoma suspect or optic nerve abnormalities
- Able and willing to complete VF testing at 2 study visits about a week apart
- Provide informed consent
Exclusion Criteria:
- History of having previously completed a VF test using Humphrey static perimetry
- Inability to understand study or communicate responses (cognitive impairment)
- Unable to understand, read and speak English fluently
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cartoon Intervention
Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry |
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Comparador activo: Usual Care
Usual care procedures for Humphrey perimetry in young children |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB)
Periodo de tiempo: 1 week
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Within subject, the investigators will determine the coefficient of variation in the mean deviation scores obtained at the two sessions a week apart (dB). The investigators will test for significant differences between subjects who receive the intervention versus the usual care control group for the test-retest variability. |
1 week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Humphrey Visual Field Reliability Indices and Ratings
Periodo de tiempo: 1 week
|
The investigators will test for significant differences between subjects who receive the intervention versus the usual care control group for the visual field reliability criteria (false negatives, false positives and fixation losses; expressed as %), and operator ratings (subjects' fixation, cooperation and fatigue; scale 1 to 5). |
1 week
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Ava Bittner, University of California, Los Angeles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KID_VF
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