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CompletedNCT05047003RESTLESSUpdated Sep 7, 2023

Oculogica Portable EyeBOX Study

An observational study in Concussion, Brain and Mild Traumatic Brain Injury, sponsored by Oculogica, Inc.. Completed at 4 sites in United States. Open to participants aged 5 Years to 67 Years. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Oculogica, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
5 Years to 67 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Concussion, Brain
  • Mild Traumatic Brain Injury
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Oculogica, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 67 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All consecutive subjects who meet all of the inclusion criteria and none of the exclusion criteria

Inclusion criteria

    1. Provide documented informed consent or assent along with guardian consent.
    1. 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.
    1. Be 5 to 67 years of age, inclusive.
    1. Have the ability to provide a complete ophthalmologic, medical, and neurologic history as well as report current medications.

Exclusion criteria

Exclusion Criteria:

    1. Have penetrating trauma or known skull fracture or intracranial injury.
    1. 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).
    1. 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.
    1. Be blind (no light perception), have missing or non-functional eyes.
    1. Be unable to open their eyes.
    1. Have a history of unresolved strabismus, diplopia, amblyopia.
    1. Have a history of unresolved cranial nerve III, IV, or VI palsy.
    1. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
    1. 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).
    1. Have a prior history of unresolved ocular-motor dysfunctions.
    1. Be intoxicated.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients under evaluation for Suspected Concussion

    Device: EyeBOX Model EBX-4 (Portable version)

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

Interventions

  • Diagnostic testEyeBOX Model EBX-4 (Portable version)

    The portable EyeBOX takes less than 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high-speed camera continuously records gaze positions. The Portable EyeBOX software detects subtle changes in eye movements consistent with concussion and calculates a BOX score.

06

What researchers measure

Primary outcomes

  1. Diagnostic accuracy of initial clinical diagnosis of concussion

    Sensitivity and Specificity compared to the initial diagnosis of concussion

    Time frame: Day 0 (when patient first presents for evaluation)

  2. Diagnostic accuracy of clinical diagnosis of post-concussion symptoms

    Sensitivity and Specificity compared to post-concussion symptoms

    Time frame: Up to one year after initial presentation

  3. Adverse Events

    Adverse events occurring during use of the diagnostic device

    Time frame: Through study participation, up to one year

Secondary outcomes

  1. Diagnostic accuracy to identify increases or decreases in post-concussion symptom severity

    Correlation with increases or decreases in post-concussion symptom severity

    Time frame: Up to one year after initial presentation

  2. Subgroup analyses

    Subgroup analyses will be performed by age, gender, and days since incident injury

    Time frame: Up to one year after initial presentation

  3. Diagnostic accuracy of initial clinical diagnosis of concussion

    Positive and negative predictive value compared to initial clinical diagnosis of concussion

    Time frame: Day 0 (when patient first presents for evaluation)

07

Study locations

4 sites
  • Redlands Chiropractic
    Redlands, California 92373, United States
  • CentraCare
    Saint Cloud, Minnesota 56303, United States
  • Prevea Health
    Green Bay, Wisconsin 54303, United States
  • Westfields Hospital
    New Richmond, Wisconsin 54017, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05047003
Lead sponsor
Oculogica, Inc.
Responsible party
Sponsor
First posted
Sep 16, 2021
Start date
Dec 19, 2020
Primary completion
Sep 1, 2022
Completion
Oct 1, 2022
Last update
Sep 7, 2023

Study contacts

Rosina Samadani, PhD
study director · Oculogica, Inc.
Amy Romandine-Kratz, MD
principal investigator · Prevea Health
Mario Chavez, DC
principal investigator · Redlands Chiropractic
Brian Lease, PT
principal investigator · Westfields Hospital
Yang K Lo, MD
principal investigator · CentraCare

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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