Clinical trial NCT05047003: Oculogica Portable EyeBOX Study
Official title: Oculogica Portable EyeBOX Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion, Brain
Mild Traumatic Brain Injury
Lead sponsor: Oculogica, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive subjects who meet all of the inclusion criteria and none of the exclusion criteria

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic accuracy of initial clinical diagnosis of concussion
timeFrame: Day 0 (when patient first presents for evaluation)
measure: Diagnostic accuracy of clinical diagnosis of post-concussion symptoms
timeFrame: Up to one year after initial presentation
measure: Adverse Events
timeFrame: Through study participation, up to one year
Secondary outcomes:
measure: Diagnostic accuracy to identify increases or decreases in post-concussion symptom severity
timeFrame: Up to one year after initial presentation
measure: Subgroup analyses
timeFrame: Up to one year after initial presentation
measure: Diagnostic accuracy of initial clinical diagnosis of concussion
timeFrame: Day 0 (when patient first presents for evaluation)
Other outcomes:
Locations:
city: Redlands
country: United States
facility: Redlands Chiropractic
state: California
city: Saint Cloud
country: United States
facility: CentraCare
state: Minnesota
city: Green Bay
country: United States
facility: Prevea Health
state: Wisconsin
city: New Richmond
country: United States
facility: Westfields Hospital
state: Wisconsin
Study officials:
affiliation: Oculogica, Inc.
name: Rosina Samadani, PhD
role: STUDY_DIRECTOR
affiliation: Prevea Health
name: Amy Romandine-Kratz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Redlands Chiropractic
name: Mario Chavez, DC
role: PRINCIPAL_INVESTIGATOR
affiliation: Westfields Hospital
name: Brian Lease, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: CentraCare
name: Yang K Lo, MD
role: PRINCIPAL_INVESTIGATOR
References: