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

2026년 5월 21일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Andrew Hartwick, OD, PhD
  • 전화번호: 16146888308
  • 이메일: HARTWICK.4@osu.edu

연구 장소

    • Ohio
      • Columbus, Ohio, 미국, 43210
        • 모병
        • College of Optometry
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
실험적: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pupil Responses
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Symptom Survey
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2005년 1월 1일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 5월 21일

처음 게시됨 (실제)

2026년 5월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 21일

마지막으로 확인됨

2026년 5월 1일

추가 정보

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미정

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아니

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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