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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07606300
Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A growing number of clinicians are regularly using fixation training, in which patients undergo daily sessions fixating on colored light targets on light boxes, to treat symptoms including photophobia associated with traumatic brain injury (TBI). While fixation training using various colored light targets is reported, blue light targets specifically appear to be used in this patient population more often than other light target colors. The College of Syntonic Optometry (www.csovision.org) estimates that there are roughly 500 practicing optometrists that utilize fixation training in the USA alone. However, evidence supporting this approach is primarily anecdotal, and there are no controlled, masked clinical trials published that evaluate the efficacy of this therapy against a control group.
Therefore, the goal of this study is to assess whether daily 20 min fixation training sessions using a blue light target alleviates symptoms of light sensitivity and alters pupil response more than daily 20 min fixation training sessions using red light targets in a masked cross-over clinical trial involving participants with chronic TBI-associated photophobia. In addition, we will determine if any improvement in symptomology correlates to any changes in pupil responses to red, blue and white light pulses and potential changes in other standard clinical measures of visual function. In short, this study will compare the effect of fixation training using a blue light target to the effect of fixation training using a red light target in participants with chronic TBI-associated photophobia.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Andrew Hartwick, OD, PhD
- Número de teléfono: 16146888308
- Correo electrónico: HARTWICK.4@osu.edu
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Reclutamiento
- College of Optometry
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Contacto:
- Andrew Hartwick, OD, PhD
- Número de teléfono: 614-688-8308
- Correo electrónico: HARTWICK.4@osu.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 18 to 80 years old and subjects able to consent for themselves
- Completion of first session in entirety (participants who cannot complete the entire first visit will be considered as a screen fail)
- Best-corrected visual acuity of at least 20/32 in both the right and left eyes, and 20/25 using both eyes
- Prior head injury with current photophobia - A mild or moderate TBI occurring at least 3 months prior to visit, verified by a score of 2, 3 or 4 on OSU-TBI survey, and participant reports having experienced greater light sensitivity since their head injury
Exclusion Criteria:
- Pregnancy or suspected pregnancy - based on self-report
- Previous history of neurodegenerative disease (e.g. Alzheimer's, Parkinson's, multiple sclerosis, myasthenia gravis, seizures)
- History of pathology of the retina and optic nerve (includes retinal tears, diabetic retinopathy, glaucoma, macular degeneration, optic nerve atrophy)
- Currently on cholinergic medications, which affect pupil responses
- Prior participation in fixation training sessions within the past 2 years
- Experiencing a migraine during visit
- Prior history of severe TBI (score of 5 or 6 on OSU-TBI survey)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Red light first, blue light second
Red light first, blue light second for the colored target used in the fixation training
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Red versus blue targets in light boxes used for fixation training
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Experimental: Blue light first, red light second
Blue light first, red light second for the colored target used in the fixation training
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Red versus blue targets in light boxes used for fixation training
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pupil Responses
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
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Pupil responses to red, blue and white light stimuli
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From baseline visit to the end of 3 months of fixation training with each light color
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Symptom Survey
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
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Symptom survey
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From baseline visit to the end of 3 months of fixation training with each light color
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Vergence facility
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
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Measurement of vergence range (how well eyes work together) with loose prisms
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From baseline visit to the end of 3 months of fixation training with each light color
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Stereopsis
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
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Measurement of local stereopsis (depth perception) with Randot test
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From baseline visit to the end of 3 months of fixation training with each light color
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Phoria magnitude
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
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Measure of phorias (how well eyes are aligned) using cover test and loose prisms
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From baseline visit to the end of 3 months of fixation training with each light color
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Near Point of Convergence
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
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Measure of ability for eyes to converge (how well eyes turn in when reading up close)
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From baseline visit to the end of 3 months of fixation training with each light color
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- Manifestaciones neurológicas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Enfermedades de los ojos
- Trastornos de la visión
- Trastornos sensoriales
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Traumatismos craneales, Cerrado
- Heridas No Penetrantes
- Lesiones Cerebrales
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Lesiones Cerebrales Traumáticas
- Contusión cerebral
- Fotofobia
Otros números de identificación del estudio
- 2023H0291
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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