An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury
Binocular ophthalmic neurodiagnostic device: Participants will undergo non-invasive binocular ophthalmic neurodiagnostic measurements and ocular assessments. No treatment or intervention will be administered as part of the study.
Study summary
The early prospective study of Traq™ (an investigational binocular ophthalmic neurodiagnostic device) will measure binocular ocular functions (bilateral foveal fixation, foveal binocularity, and fovea-tracked saccadic latency) in normal subjects and those with history of mild-to moderate traumatic brain injury (mTBI).
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age 12 years or older at the time of enrollment.
2. Able to understand and sign an informed consent form (or with parent/guardian for subjects less than 18 years of age).
3. Willing and able to complete all required study visits and test assessments.
4. Subjects with no history of traumatic brain injury (normal arm).
5. Subjects with a history of mild to moderate traumatic brain injury (mTBI) within the last six months, (post-TBI arm).
Exclusion Criteria:
1. Concurrent participation in another drug or device clinical investigation.
2. Subject with a history of eye disease which could reduce, or limit reflected polarized light from the retina, such as corneal scarring, cataract, glaucoma, degenerative retinal conditions (e.g., age-related macular degeneration, diabetic retinopathy), or other conditions which may decrease device signal reflectance.
3. Subjects who are pregnant, planning to become pregnant, or are breastfeeding.
Primary outcome measure(s)
Device Metrics — Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90. A composite Traq score will be calculated on a scale of 0.00-to-2.00 at each visit. The score will be a calculated combination of the following, additional outcome measures:
* Bilateral foveal fixation
* Foveal binocularity
* Fovea-tracked saccadic latency
Device Metrics — Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90. Bilateral foveal fixation will be measured as a percentage (from 0.00-1.00%) of time in which both eyes fixate together during the scan.
Foveal fixation — Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90. The device will capture each individual eye's ability to fixate as a percentage (from 0.00 to 1.00) of time during the scan. A result will be provided for each individual eye.
Device outputs — Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90. Fovea-tracked saccadic latency will be calculated in milliseconds to measure when fixation is attained and lost throughout the scan.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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