An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury
Rebiscan, Inc.
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).
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
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- Yes
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 dis…
Interventions
- DeviceBinocular 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.
Location
- Elite Eye Care/Elite Vision TherapyWaukee, Iowa