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

RecruitingNAAges 18 Years - 80 YearsAllOhio State University
NCT07606300 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Fixation training using different colored fixation targets
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Where

1 site
College of Optometry
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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