An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Binocular ophthalmic neurodiagnostic device.
- Who it may be relevant to
- Registry conditions: Mild Traumatic Brain Injury, Concussion, Binocular Visual Function, Neuro-Ophthalmology, Saccadic Eye Movements. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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).
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
- Device Binocular 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.
Primary outcome measures
- Device Metrics [Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.]
- Device Metrics [Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.]
- Foveal fixation [Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.]
- Device outputs [Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Elite Eye Care/Elite Vision Therapy — Waukee
Identifiers
NCT: NCT07742878 · REB-001