Traq device test of binocular eye function in people with and without a concussion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective observational study comparing binocular ocular function between normal subjects and individuals with a recent mild-to-moderate traumatic brain injury. It uses the Traq device to measure metrics such as bilateral foveal fixation, foveal binocularity, and fovea-tracked saccadic latency. The study is non-randomized and non-mmasked, enrolling participants 12 years and older who meet inclusion criteria and have no exclusion conditions that would affect device signal. Data collected will help characterize how Traq measurements differ between the two populations and establish baseline measurement characteristics. The lead sponsor is Rebiscan, Inc., with Elite Eye Care/Elite Vision Therapy as the location site in Waukee, Iowa.

Why it matters

Who can join: the full rules

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.

Where it's running

• Elite Eye Care/Elite Vision Therapy
  Waukee, Iowa, United States Recruiting

Study contacts

• Principal investigator: Heidi Bell, OD — Elite Eye Car / Elite Vision Therapy
• Study coordinator: Justin Shaka
• Email: jgshaka@rebiscan.com
• Phone: 857-600-0982

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.