Recruiting

Blue & Red Light

Sponsor:

Ohio State University

Code:

NCT07606300

Conditions

Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Fixation training using different colored fixation targets

Study Details

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

Study ID

NCT07606300

Start date

Jan, 2005

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Red light first, blue light second

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

experimental: Blue light first, red light second

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

Interventions

Fixation training using different colored fixation targets

Red versus blue targets in light boxes used for fixation training

Primary outcome measure

  • Pupil Responses [ Time Frame: From baseline visit to the end of 3 months of fixation training with each light color ]

Central Contacts and Locations

Central contacts

Andrew Hartwick, OD, PhD

16146888308HARTWICK.4@osu.edu

Locations

College of Optometry

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Andrew Hartwick, OD, PhD

614-688-8308HARTWICK.4@osu.edu

More Information

Sponsor

Ohio State University

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • traumatic brain injury
  • concussion
  • photophobia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-05-26.