NCT07606300 · Ohio State University
Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Fixation training using different colored fixation targets
Red versus blue targets in light boxes used for fixation training
Primary outcome measures
Pupil Responses
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Columbus, Ohio
Collaborators
Ohio Lions Eye Research Fund
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 26, 2026 · Source of record for eligibility and locations