Binocular Visual Function, Mild Traumatic Brain Injury, Concussion, Neuro-Ophthalmology, Saccadic Eye Movements
Conditions
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.
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.
Sponsors
Rebiscan, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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 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. 3. Subjects who are pregnant, planning to become pregnant, or are breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Metrics | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTJustin Shaka
PRINCIPAL_INVESTIGATORHeidi Bell, OD
Elite Eye Car / Elite Vision Therapy
Outcome results
None listed