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NCT Number: NCT07742878

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

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).

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Key information

Conditions

Mild Traumatic Brain Injury, Concussion Binocular Visual Function Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Neuro-Ophthalmology Saccadic Eye Movements Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Elite Eye Care/Elite Vision Therapy

Waukee, Iowa, 50263, United States

Location status: Recruiting

Location contact

Heidi Bell, OD

CONTACT

[email protected]

515-987-3937

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Subjects with a history of mild to moderate traumatic brain injury (mTBI) within the last six months, (post-TBI arm).

Exclusion criteria

  • 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.

Treatment and study plan

Binocular ophthalmic neurodiagnostic device

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.

Primary outcomes

  1. Device Metrics

    Time frame: 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

  2. Device Metrics

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

    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.

  3. Foveal fixation

    Time frame: 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.

  4. Device outputs

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Justin Shaka

CONTACT

[email protected]

857-600-0982

Sponsors and collaborators

Lead sponsor

Rebiscan, Inc.

Industry

Registry information

Acronym: REB-001

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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