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

NCT07742878 | Recruiting FDA Device

• 1 other identifier: REB-001
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

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

Study Arms (2)

Head trauma group

Subjects with history of head trauma within the prior 6 months

Device: Binocular ophthalmic neurodiagnostic device

Controls

Subjects with no history of head trauma

Device: Binocular ophthalmic neurodiagnostic device

Interventions

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.

Controls; Head trauma group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eye care clinic patients

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rebiscan, Inc.: lead

Study Sites (1)

Elite Eye Care/Elite Vision Therapy

Waukee, Iowa, 50263, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Heidi Bell, OD

  Elite Eye Car / Elite Vision Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Shaka

CONTACT

857-600-0982; jgshaka@rebiscan.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 3, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

US (1)