Blue vs red fixation training for light sensitivity after brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares two fixation training regimens using colored light targets in adults with chronic TBI-associated photophobia. Participants undergo 12 weeks of at-home sessions, alternating between blue and red light targets in a masked cross-over design. Outcomes include changes in light sensitivity, pupil responses to light pulses, and other visual function measures. The trial addresses the lack of controlled evidence for fixation training as a treatment for photophobia after brain injury. The study is sponsored by Ohio State University in collaboration with the Ohio Lions Eye Research Fund and conducted at the College of Optometry in Columbus, Ohio.

Why it matters

Who can join: the full rules

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 it's running

• College of Optometry
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Andrew Hartwick, OD, PhD
• Email: HARTWICK.4@osu.edu
• Phone: 16146888308

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Smartphone-based EEG to detect hidden awareness in ICU patients with brain injuries

  Researchers will test a smartphone-enabled EEG to see if it can reveal Cognitive Motor Dissociation in ICU patients who can’t show commands at bedside.

  Recruiting Columbia University · Miami, Florida and 8 other locations · NCT07917728

• Propranolol for Severe Traumatic Brain Injury in the ICU

  A randomized, triple-blind trial tests whether propranolol helps adults with moderate to severe TBI in the ICU.

  Recruiting at 5 sites Phase 3 Fundació d'investigació Sanitària de les Illes Balears · Palma de Mallorca, Balearic Islands and 5 other locations · NCT07899164

• Hyperbaric Oxygen Therapy for Veterans With TBI and PCS

  This study tests whether 40 HBOT sessions can change blood biomarkers in veterans with traumatic brain injury and persistent symptoms, and whether PTSD affects those biomarker changes.

  Recruiting Phase 2 Summit Hyperbarics and Wellness · Boise, Idaho · NCT07849465

• Sleep patterns to help predict waking from brain injury

  Doctors are testing whether brain activity during sleep can help predict when a person with a serious brain injury will regain awareness.

  Recruiting Columbia University · Miami, Florida and 1 other locations · NCT07794605

• SeeMe: automated facial and hand tracking to reveal hidden responses after traumatic brain injury

  This project tests whether a high-resolution camera system with AI can detect very small, voluntary facial and hand movements in adults with severe traumatic brain injury who appear unresponsive.

  Recruiting Stony Brook University · Stony Brook, New York · NCT07560631

• Using a portable VR headset to measure pupil reactions for diagnosing and monitoring head injury

  This research tests whether a VR headset that flashes brief, gentle colored lights can detect and track traumatic brain injury by measuring how the pupil responds in people with TBI, similar non-TBI trauma patients, and healthy adults.

  Recruiting Sheba Medical Center · Tel HaShomer, Tel Aviv (Gosh Dan) · NCT07474987

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.