Actively Recruiting
Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia
Led by Ohio State University · Updated on 2026-05-26
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
O
Ohio Lions Eye Research Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how daily fixation training using colored light targets affects light sensitivity in people who have had a traumatic brain injury (TBI). Many people with TBI develop intolerance to ambient light, but it is unclear why and how best to treat this symptom. This clinical trial aims to compare the effects of blue light versus red light targets in reducing light intolerance and altering pupil responses in individuals with chronic TBI-related photophobia. Participants will use an at-home fixation device for daily 20-minute sessions over 12 weeks, starting with either a blue or red light target. After the first 12 weeks, participants will switch to the other colored light target for another 12 weeks. This crossover design allows comparison of the two light colors. Masked examiners will evaluate vision and eye function every 6 weeks during the study, including reading ability, pupil responses, side vision, eye alignment, and focusing ability. Throughout the study, participants will complete symptom surveys and undergo several vision tests to assess the effect of the training. The primary outcome measured is the change in pupil responses from baseline to the end of each 12-week training period. Secondary outcomes include symptom changes and various measures of visual function. The total participation time covers both 12-week treatment periods with evaluations at regular intervals, aiming to understand if blue light fixation training offers greater benefits than red light for TBI-associated light sensitivity.
CONDITIONS
Brief Title
Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years and able to consent for themselves
- Completion of the entire first training session
- Best-corrected visual acuity of at least 20/32 in each eye and 20/25 binocularly
- History of mild or moderate traumatic brain injury at least 3 months prior with increased light sensitivity since injury verified by OSU-TBI survey score 2, 3, or 4
You will not qualify if you...
- Pregnancy or suspected pregnancy
- History of neurodegenerative diseases such as Alzheimer's, Parkinson's, multiple sclerosis, myasthenia gravis, or seizures
- Eye diseases including retinal tears, diabetic retinopathy, glaucoma, macular degeneration, or optic nerve atrophy
- Use of cholinergic medications affecting pupil response
- Participation in fixation training sessions within the past 2 years
- Experiencing a migraine during visits
- History of severe traumatic brain injury with OSU-TBI survey score 5 or 6
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months with each light color
Participants undergo daily 20-minute fixation training sessions using colored light targets, alternating between red and blue lights in a crossover design to assess effects on light sensitivity and pupil response.
Daily sessions for 3 months per light color
Trial Site Locations
Total: 1 location
1
College of Optometry
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
A
Andrew Hartwick, OD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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