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NCT07606300 · ClinicalTrials.gov registry record · NA
Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia
A NA study, sponsored by Ohio State University.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT07606300 is a NA study that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 20 participants.
The verdict
NCT07606300, a NA study, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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 o
Interventions
- BEHAVIORAL Fixation training using different colored fixation targets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-01 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07606300
The ClinicalTrials.gov registry entry for NCT07606300 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fixation training using different colored fixation targets is the first listed.
NCT07606300 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07606300 about?
NCT07606300 is a clinical study titled "Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia". 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 underg...
What is the current status of trial NCT07606300?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2005-01. Estimated completion is 2026-12.
What interventions are being tested in trial NCT07606300?
The interventions under investigation include: Fixation training using different colored fixation targets (BEHAVIORAL).
Who is sponsoring clinical trial NCT07606300?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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