Oculogica Portable EyeBOX Study (RESTLESS)

Oculogica

Status: Completed

Conditions: Mild Traumatic Brain Injury; Concussion, Brain

Treatments: Diagnostic Test: EyeBOX Model EBX-4 (Portable version)

Study type: Observational

Funder types: Industry

Identifiers

NCT05047003

MTBI003

Details and patient eligibility

About

The objective of this study is to assess the accuracy of a portable version of the EyeBOX device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of concussion. The utility of the portable assessment to aid in the monitoring of symptoms over time after an initial diagnosis of concussion will also be evaluated.

Enrollment: 100 patients

Sex: All

Ages: 5 to 67 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Provide documented informed consent or assent along with guardian consent.
• 2. Have presented, at any time post injury, for any complaint related to an injury involving either a direct force to the head or a blow to the body that has the potential to transmit a rapid acceleration/deceleration of the head, with or without loss of consciousness, with or without external signs of head injury.
• 3. Be 5 to 67 years of age, inclusive.
• 4. Have the ability to provide a complete ophthalmologic, medical, and neurologic history as well as report current medications.

Exclusion criteria

• 1. Have penetrating trauma or known skull fracture or intracranial injury.
• 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. Any of the following conditions, immediately related to the incident injury: loss of consciousness exceeding 30 minutes or best available Glasgow Coma Scale (GCS) score less than 13 within 24 hours or other acute conditions requiring emergency medical management.
• 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 or scarring (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).
• 10. Have a prior history of unresolved ocular-motor dysfunctions.
• 11. Be intoxicated.

Trial design

100 participants in 1 patient group

Patients under evaluation for Suspected Concussion

Description:

Device: EyeBOX Model EBX-4 (Portable version)

Treatment:

Diagnostic Test: EyeBOX Model EBX-4 (Portable version)