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

NCT07606300 | Recruiting

• 1 other identifier: 2023H0291
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury (TBI) Patients

Keywords

traumatic brain injury; concussion; photophobia

Outcome Measures

Primary Outcomes (1)

• Pupil Responses

  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

Secondary Outcomes (5)

• Symptom Survey

  From baseline visit to the end of 3 months of fixation training with each light color

• Vergence facility

  From baseline visit to the end of 3 months of fixation training with each light color

• Stereopsis

  From baseline visit to the end of 3 months of fixation training with each light color

• Phoria magnitude

  From baseline visit to the end of 3 months of fixation training with each light color

• Near Point of Convergence

  From baseline visit to the end of 3 months of fixation training with each light color

Study Arms (2)

Red light first, blue light second

EXPERIMENTAL

Red light first, blue light second for the colored target used in the fixation training

Behavioral: Fixation training using different colored fixation targets

Blue light first, red light second

EXPERIMENTAL

Blue light first, red light second for the colored target used in the fixation training

Behavioral: Fixation training using different colored fixation targets

Interventions

Fixation training using different colored fixation targets BEHAVIORAL

Red versus blue targets in light boxes used for fixation training

Blue light first, red light second; Red light first, blue light second

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University: lead
• Ohio Lions Eye Research Fund: collaborator

Study Sites (1)

College of Optometry

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Photophobia

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrew Hartwick, OD, PhD

CONTACT

16146888308; HARTWICK.4@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will start with one color of light (either red or blue) for the fixation light and switch to the other light halfway through study.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 26, 2026
• Study Start: January 1, 2005
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

US (1)