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NCT07742878RecruitingAccepts Healthy Volunteers

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.

Start Date

7/14/2026

Completion Date

10/1/2026

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.

Eligibility Criteria

Age Range: 12 years to No maximum

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.

Interventions

DEVICE

Binocular ophthalmic neurodiagnostic device

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Conditions

Mild Traumatic Brain Injury, ConcussionBinocular Visual FunctionNeuro-OphthalmologySaccadic Eye Movements

Locations

Elite Eye Care/Elite Vision Therapy

Waukee, Iowa 50263

United States