An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Rebiscan, Inc.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Device Metrics
Study Overview
Brief 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).
Detailed Description
An initial, single-center, prospective, non-masked, non-randomized, parallel-arm clinical study designed to collect Traq™ measurement data from normal subjects (normal arm) and subjects with a history of mild to moderate traumatic brain injury (mTBI) within the last six months (post-TBI arm) to characterize binocular ocular function measurement outcomes across the two study populations.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 12 years or older at the time of enrollment.
- •Able to understand and sign an informed consent form (or with parent/guardian for subjects less than 18 years of age).
- •Willing and able to complete all required study visits and test assessments.
- •Subjects with no history of traumatic brain injury (normal arm).
- •Subjects with a history of mild to moderate traumatic brain injury (mTBI) within the last six months, (post-TBI arm).
Exclusion Criteria
- •Concurrent participation in another drug or device clinical investigation.
- •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.
- •Subjects who are pregnant, planning to become pregnant, or are breastfeeding.
Outcomes
Primary Outcomes
Device Metrics
Time Frame: 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
Foveal fixation
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported