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

Conditions

• Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Fixation training using different colored fixation targets — BEHAVIORAL
  Red versus blue targets in light boxes used for fixation training

Study Details

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.

Key Dates

Start date

Jan 31, 2005

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

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

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

• Andrew Hartwick, OD, PhD
  16146888308
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

Related Studies

• Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury
  Recruiting · MetroHealth Medical Center · Cleveland, Ohio
• Early Neuromodulation in Traumatic Brain Injury
  Recruiting · University of Cincinnati · Cincinnati, Ohio
• Transcutaneous Vagus Nerve Stimulation for Attention and Memory
  Recruiting · Baylor College of Medicine · Houston, Texas
• External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients
  Recruiting · Johns Hopkins University · Baltimore, Maryland