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

21 de maio de 2026 atualizado 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.

Visão geral do estudo

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Andrew Hartwick, OD, PhD
  • Número de telefone: 16146888308
  • E-mail: HARTWICK.4@osu.edu

Locais de estudo

    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Recrutamento
        • College of Optometry
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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)

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Pupil Responses
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Symptom Survey
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2005

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de maio de 2026

Primeira postagem (Real)

26 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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