EyeBOX Concussion Study and Registry

Oculogica

Status: Completed

Conditions: Mild Traumatic Brain Injury; Concussion, Brain

Treatments: Diagnostic Test: EyeBOX device

Study type: Observational

Funder types: Industry

Identifiers

NCT03966404

MTBI002

Details and patient eligibility

About

The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of concussion.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provide written informed consent or assent along with guardian consent.
2. Have sustained a suspected direct or indirect force to the head with or without documented loss of consciousness, memory loss, alteration in consciousness or neurologic deficits. Only individuals presenting for initial evaluation of concussion may be enrolled, however longitudinal assessments may be conducted on enrolled subjects.
3. Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking.

Exclusion criteria

1. Have penetrating trauma.
2. Have had a conventional head CT or MRI demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
3. Either of the following conditions, immediately related to the incident head trauma: loss of consciousness exceeding 30 minutes or best available GCS score less than 13 within 24 hours.
4. Be blind (no light perception), have missing or non-functional eyes.
5. Be unable to open their eyes.
6. Have a history of unresolved strabismus, diplopia, amblyopia.
7. Have a history of unresolved cranial nerve III, IV, or VI palsy.
8. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
9. Have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions) or scarring.
10. Have a prior history of unresolved ocular-motor dysfunctions.
11. Be intoxicated.