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.10 enrolled

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Mild Traumatic Brain Injury, Concussion Binocular Visual Function Neuro-Ophthalmology Saccadic Eye Movements

Interventions

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.

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.

Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.

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.

Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.

Device outputs

Fovea-tracked saccadic latency will be calculated in milliseconds to measure when fixation is attained and lost throughout the scan.

Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.

An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts