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).
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).
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.
Eye care clinic patients
Cohort
Prospective
Binocular ophthalmic neurodiagnostic device
DeviceParticipants will undergo non-invasive binocular ophthalmic neurodiagnostic measurements and ocular assessments. No treatment or intervention will be administered as part of the study.
Device Metrics
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
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
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
Fovea-tracked saccadic latency will be calculated in milliseconds to measure when fixation is attained and lost throughout the scan.
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