EyeBOX Concussion Study and Registry

Oculogica, Inc.1 site in 1 country200 target enrollmentAugust 5, 2019

ConditionsConcussion, Brain Mild Traumatic Brain Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Concussion, Brain
Sponsor: Oculogica, Inc.
Enrollment: 200
Locations: 1
Primary Endpoint: diagnostic accuracy of clinical diagnosis of post-concussion symptoms
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 5, 2019

End Date

June 1, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Oculogica, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provide written informed consent or assent along with guardian consent.
•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.
•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

•Have penetrating trauma.
•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).
•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.
•Be blind (no light perception), have missing or non-functional eyes.
•Be unable to open their eyes.
•Have a history of unresolved strabismus, diplopia, amblyopia.
•Have a history of unresolved cranial nerve III, IV, or VI palsy.
•Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
•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.
•Have a prior history of unresolved ocular-motor dysfunctions.

Outcomes

Primary Outcomes

diagnostic accuracy of clinical diagnosis of post-concussion symptoms

Time Frame: up to one year after initial presentation

sensitivity and specificity compared to clinical diagnosis of post-concussion symptoms

diagnostic accuracy of initial clinical diagnosis of concussion

Time Frame: day 0 (when patient first presents for evaluation)

sensitivity and specificity compared to initial clinical diagnosis of concussion

adverse events

Time Frame: through study participation, up to one year

adverse events occurring during use of the diagnostic device

Secondary Outcomes

correlation with increases or decreases in post-concussion symptom severity(up to one year after initial presentation)
diagnostic accuracy of initial clinical diagnosis of concussion(day 0 (when patient first presents for evaluation))