Overview
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).
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.
Eligibility
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.
