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Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia

21 de mayo de 2026 actualizado por: Ohio State University
Many people develop intolerance to light after a head injury, leading to ambient light levels causing discomfort. We do not fully understand why this occurs and how it should be treated. A growing number of clinicians have reported improvement in TBI related symptoms reported by patients that undergo daily fixation training with a dim light target. 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. However, the effectiveness of this approach has yet to be assessed in a well-controlled clinical study. In this work, we will recruit individuals who had a recent brain injury and developed increased light sensitivity. Participants will be divided into two groups: one that first uses daily 20 minute sessions for 12 weeks with the at-home fixation device set to display a blue light target; and another that will undergo similar sessions for 12 weeks using a red light target. Every 6 weeks, masked examiners will measure how well participants can read letters on an eye chart, record pupil responses to light, measure the side vision, measure eye alignment and focusing ability when viewing a near target, and collect information about participants' symptoms. In a cross-over study design, the participants will then switch to sessions involving the other colored fixation light target for another 12 weeks, with data being again collected every 6 weeks. Potential differences in pupil responses to light between the treatment groups will be assessed as an objective outcome measure and compared to subjective symptom survey information. Thus, this work will test the hypothesis that daily fixation training using a blue light target can alleviate light intolerance in participants after head injury more than fixation training with a red light target, and this improvement is associated with altered pupil responses to light. As a significant minority of eye care clinicians currently utilize this approach in this population of patients, this study has the potential to influence clinical practice patterns whether the fixation training is shown to be effective or not.

Descripción general del estudio

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

Intervencionista

Inscripción (Estimado)

20

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Andrew Hartwick, OD, PhD
  • Número de teléfono: 16146888308
  • Correo electrónico: HARTWICK.4@osu.edu

Ubicaciones de estudio

    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Reclutamiento
        • College of Optometry
        • Contacto:
          • Andrew Hartwick, OD, PhD
          • Número de teléfono: 614-688-8308
          • Correo electrónico: HARTWICK.4@osu.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: Red light first, blue light second
Red light first, blue light second for the colored target used in the fixation training
Red versus blue targets in light boxes used for fixation training
Experimental: Blue light first, red light second
Blue light first, red light second for the colored target used in the fixation training
Red versus blue targets in light boxes used for fixation training

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pupil Responses
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
Pupil responses to red, blue and white light stimuli
From baseline visit to the end of 3 months of fixation training with each light color

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Symptom Survey
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
Symptom survey
From baseline visit to the end of 3 months of fixation training with each light color
Vergence facility
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
Measurement of vergence range (how well eyes work together) with loose prisms
From baseline visit to the end of 3 months of fixation training with each light color
Stereopsis
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
Measurement of local stereopsis (depth perception) with Randot test
From baseline visit to the end of 3 months of fixation training with each light color
Phoria magnitude
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
Measure of phorias (how well eyes are aligned) using cover test and loose prisms
From baseline visit to the end of 3 months of fixation training with each light color
Near Point of Convergence
Periodo de tiempo: From baseline visit to the end of 3 months of fixation training with each light color
Measure of ability for eyes to converge (how well eyes turn in when reading up close)
From baseline visit to the end of 3 months of fixation training with each light color

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2005

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de mayo de 2026

Publicado por primera vez (Actual)

26 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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