Oculogica Portable EyeBOX Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-19

Study Completion Date

2022-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

EyeBOX Concussion Study and Registry

NCT03966404

Concussion, Brain Mild Traumatic Brain Injury

COMPLETED

A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings

NCT05527041

Concussion, Brain Mild Traumatic Brain Injury

ENROLLING_BY_INVITATION

Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients

NCT02776462

Brain Concussion Cerebral Concussion Concussion, Intermediate +5 more

COMPLETED

EYE-SYNC Concussion Classification Study

NCT04381767

Concussion, Mild Concussion; Eye Concussion, Brain +3 more

COMPLETED

Oculomotor Assessment of Traumatic Brain Injury (TBI)

NCT03156010

Traumatic Brain Injury

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Concussion, Brain Mild Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients under evaluation for Suspected Concussion

Device: EyeBOX Model EBX-4 (Portable version)

EyeBOX Model EBX-4 (Portable version)

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EyeBOX 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No