mTBI Identification and Monitoring Through Retinal Scanning
ConditionBrain Injuries, Traumatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorRebiscan, Inc.
About this trial
Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 60 TBI patients and 20 controls.
Eligibility criteria
Qualifiers
Age 18-45 years
Presents to the facility within 2 weeks of head trauma
Able to provide informed consent
If minor, then able to provide parental consent and minor consent
Disqualifiers
Glasgow Coma Scale score equal to or less than 13 at the time of study enrollment
Under the influence of alcohol or drugs
Previous eye surgery
Visual acuity known to be 20/200 or less in either eye
Trial design
Treatments tested in this trial
- Head and Intraocular Trauma Tool
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rebiscan, Inc.
Lead sponsor
Boston Medical Center
Collaborator
Source ClinicalTrials.gov