Oculogica Portable EyeBOX Study

Completed

• Conditions: Concussion, Brain; Mild Traumatic Brain Injury
• Interventions: Diagnostic Test: EyeBOX Model EBX-4 (Portable version)

• Registration Number: NCT05047003
• Lead Sponsor: Oculogica, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-19
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-16
• Primary Completion: 2022-09-01
• Study Completion: 2022-10-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients under evaluation for Suspected Concussion	EyeBOX Model EBX-4 (Portable version)	Device: EyeBOX Model EBX-4 (Portable version)

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of clinical diagnosis of post-concussion symptoms	Up to one year after initial presentation	Sensitivity and Specificity compared to post-concussion symptoms
Diagnostic accuracy of initial clinical diagnosis of concussion	Day 0 (when patient first presents for evaluation)	Sensitivity and Specificity compared to the initial diagnosis of concussion
Adverse Events	Through study participation, up to one year	Adverse events occurring during use of the diagnostic device

Secondary Outcome Measures

Name	Time	Method
Diagnostic accuracy to identify increases or decreases in post-concussion symptom severity	Up to one year after initial presentation	Correlation with increases or decreases in post-concussion symptom severity
Diagnostic accuracy of initial clinical diagnosis of concussion	Day 0 (when patient first presents for evaluation)	Positive and negative predictive value compared to initial clinical diagnosis of concussion
Subgroup analyses	Up to one year after initial presentation	Subgroup analyses will be performed by age, gender, and days since incident injury

Trial Locations

Locations (4)

Prevea Health; 🇺🇸 Green Bay, Wisconsin, United States

Westfields Hospital; 🇺🇸 New Richmond, Wisconsin, United States

Redlands Chiropractic; 🇺🇸 Redlands, California, United States

CentraCare; 🇺🇸 Saint Cloud, Minnesota, United States