About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Binocular ophthalmic neurodiagnostic device