NCT05527041
A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings
Enrolling by Invitation
Not specifiedAges 17–35ObservationalOculogica, Inc.
~1,600 participants
Updated 2025-07-31 on ClinicalTrials.gov
What's tested:EyeBOX Lens (EBLens)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic accuracy of acute clinical diagnosis of concussion using EBLens form factor and algorithm
Measured over Within 72 hours of injury
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Kenneth Cameron, PhD · PRINCIPAL_INVESTIGATOR · Keller Army Community Hospital
- Christina Master, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
- Sadie Buboltz-Dubs, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin - Green Bay
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Provide documented informed consent.
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.
Be a current cadet/enrolled student age 17-34.
Have the ability to provide a complete ophthalmologic, medical, and neurologic history as well as report current medications.
Provide documented informed consent.
Be a current cadet/enrolled student age 17-34.
Have the ability to provide a complete ophthalmologic, medical, and neurologic history as well as report current medications.
Exclusion
Have penetrating trauma or known skull fracture or intracranial injury.
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).
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 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).
Have a prior history of unresolved ocular-motor dysfunctions.
Be intoxicated.
Have presented, within the prior six months, 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.
Have penetrating trauma or known skull fracture or intracranial injury.
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).
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 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).
Have a prior history of unresolved ocular-motor dysfunctions.
Be intoxicated.
What this trial measures
- Diagnostic accuracy of acute clinical diagnosis of concussion using EBLens form factor and algorithmWithin 72 hours of injury
The EBLens will have at least 70% sensitivity and specificity for diagnosis of acute concussion