An interventional study of Fixation training using different colored fixation targets in Traumatic Brain Injury (TBI) Patients, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
A growing number of clinicians are regularly using fixation training, in which patients undergo daily sessions fixating on colored light targets on light boxes, to treat symptoms including photophobia associated with traumatic brain injury (TBI). 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. The College of Syntonic Optometry (www.csovision.org) estimates that there are roughly 500 practicing optometrists that utilize fixation training in the USA alone. However, evidence supporting this approach is primarily anecdotal, and there are no controlled, masked clinical trials published that evaluate the efficacy of this therapy against a control group.
Therefore, the goal of this study is to assess whether daily 20 min fixation training sessions using a blue light target alleviates symptoms of light sensitivity and alters pupil response more than daily 20 min fixation training sessions using red light targets in a masked cross-over clinical trial involving participants with chronic TBI-associated photophobia. In addition, we will determine if any improvement in symptomology correlates to any changes in pupil responses to red, blue and white light pulses and potential changes in other standard clinical measures of visual function. In short, this study will compare the effect of fixation training using a blue light target to the effect of fixation training using a red light target in participants with chronic TBI-associated photophobia.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
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Exclusion Criteria:
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 for the colored target used in the fixation training
Behavioral: Fixation training using different colored fixation targets
Red versus blue targets in light boxes used for fixation training
Pupil Responses
Pupil responses to red, blue and white light stimuli
Time frame: From baseline visit to the end of 3 months of fixation training with each light color
Symptom Survey
Symptom survey
Time frame: From baseline visit to the end of 3 months of fixation training with each light color
Vergence facility
Measurement of vergence range (how well eyes work together) with loose prisms
Time frame: From baseline visit to the end of 3 months of fixation training with each light color
Stereopsis
Measurement of local stereopsis (depth perception) with Randot test
Time frame: From baseline visit to the end of 3 months of fixation training with each light color
Phoria magnitude
Measure of phorias (how well eyes are aligned) using cover test and loose prisms
Time frame: From baseline visit to the end of 3 months of fixation training with each light color
Near Point of Convergence
Measure of ability for eyes to converge (how well eyes turn in when reading up close)
Time frame: From baseline visit to the end of 3 months of fixation training with each light color
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2005 (actual). Primary completion is estimated for Dec 2026, 263 months after the start.
Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's planned 263 months is above that.
Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
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