College of Optometry
Columbus, Ohio, 43210, United States
Location status: Recruiting
NCT Number: NCT07606300
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.
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Request Info18 year–80 year
All sexes
Interventional
Not applicable
Columbus, Ohio, 43210, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Red versus blue targets in light boxes used for fixation training
Time frame: From baseline visit to the end of 3 months of fixation training with each light color
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
Time frame: From baseline visit to the end of 3 months of fixation training with each light color
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
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
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
Measure of ability for eyes to converge (how well eyes turn in when reading up close)
Contact information is provided by the study sponsor or research team.
Ohio State University
Other
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