Wave Form Signals Coming From the Eye in a Healthy CohortKYNCT03653936
Neuro-ocular Baselines in a Sports Setting
An observational study of Wave Form Signals Coming From the Eye in a Healthy Cohort, run by Rebiscan, Inc. at 1 site in United States.
Trial summary
Rebion (Rebiscan, Inc) has developed a noninvasive, handheld device that uses retinal birefringence scanning (RBS) to rapidly assess eye fixation and retinal integrity in adults and children. Read more about this study
- Who is it for?
- Ages 11 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Wave Form Signals Coming From the Eye in a Healthy Cohort
- What is being tested?
- HITT device
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Cohort study of individuals tested with the Rebion device followed by SCAT3 examination. Two data sets will be taken and compared: a cohort with non-contact sport athletes (swimmers, tennis, track) and a cohort of contact sport athletes (lacrosse, spring football, and spring soccer).
Who may be able to join
- Student-athletes who present to schools affiliated with the Bluegrass Sports Clinica
- Engaged in sports
- Older or equal to 11 years of age, and less than 21 years of age.
- Provide informed consent; youths must have their parents sign the informed consent document. Children will be presented with a written assent statement and that they will be asked to sign the assent document.
Who cannot join
- Catastrophic polytrauma that would interfere with follow-up and outcome assessment
- Amblyopia/strabismus
- Pregnancy in female subjects
- Any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket (or any fracture to face that would negatively impact eye movement/vision) that would interfere with ability to complete study-device assessment.
- History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)
- Intoxication or chemical impairment at time of examination (upon initial presentation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuro-ocular Baselines in a Sports Setting: Feasibility Study for Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction
Rebion (Rebiscan, Inc) has developed a noninvasive, handheld device that uses retinal birefringence scanning (RBS) to rapidly assess eye fixation and retinal integrity in adults and children. The proprietary technology uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. The project described herein aims to provide accurate assessment of brain dysfunction in TBI (Traumatic Brain Injury) patients through the use of the developed device, which is called the Head and Intraocular Trauma Test (HITT) device.
- Being tested
- HITT device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITT deviceDevice
Rebion has developed a noninvasive, handheld device that uses retinal polarization scanning (RPS) to rapidly assess eye fixation and retinal integrity in adults and children. RPS can automatically detect the fixation of the human eye with proprietary technology that uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. RPS requires no calibration or imaging, and eye movement recordings are not required. The HITT device is a repurposed Pediatric Vision Scanner (PVS), Rebion's first commercial product which has passed all applicable safety and performance standards.
What is being measured
The primary outcome is the main question the study is designed to answer.
Capturing of wave forms from the eye
Screening device will provide a wave form calculation of light reflecting off patient's eye
Measured: Screenings will be performed during a normally scheduled visit to the sports facility by the research group enrolling in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Apr 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wave Form Signals Coming From the Eye in a Healthy CohortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebiscan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BlueGrass Orthopaedics Surgery & Hand Care
- Responsible party
- Sponsor
- Investigators
- Harry Lockstadt, MD, Principal investigator, Bluegrass Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653936
- Sponsor's protocol ID
- Rebiscan-005
- Acronym
- KY
- Status last verified
- Apr 2019
- First submitted
- 28 Aug 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-ocular Baselines in a Sports Setting: Feasibility Study for Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction
- ClinicalTrials.gov ID
- NCT03653936
- Acronym / sponsor ID
- KY / Rebiscan-005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Rebiscan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- BlueGrass Orthopaedics Surgery & Hand Care
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rebion (Rebiscan, Inc) has developed a noninvasive, handheld device that uses retinal birefringence scanning (RBS) to rapidly assess eye fixation and retinal integrity in adults and children. The proprietary technology uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. The project described herein aims to provide accurate assessment of brain dysfunction in TBI (Traumatic Brain Injury) patients through the use of the developed device, which is called the Head and Intraocular Trauma Test (HITT) device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Cohort study of individuals tested with the Rebion device followed by SCAT3 examination. Two data sets will be taken and compared: a cohort with non-contact sport athletes (swimmers, tennis, track) and a cohort of contact sport athletes (lacrosse, spring football, and spring soccer).
Key inclusion criteria (4 listed)
- Student-athletes who present to schools affiliated with the Bluegrass Sports Clinica
- Engaged in sports
- Older or equal to 11 years of age, and less than 21 years of age.
- Provide informed consent; youths must have their parents sign the informed consent document. Children will be presented with a written assent statement and that they will be asked to sign the assent document.
Key exclusion criteria (6 listed)
- Catastrophic polytrauma that would interfere with follow-up and outcome assessment
- Amblyopia/strabismus
- Pregnancy in female subjects
- Any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket (or any fracture to face that would negatively impact eye movement/vision) that would interfere with ability to complete study-device assessment.
- History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HITT deviceRebion has developed a noninvasive, handheld device that uses retinal polarization scanning (RPS) to rapidly assess eye fixation and retinal integrity in adults and children. RPS can automatically detect the fixation of the human eye with proprietary technology that uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. RPS requires no calibration or imaging, and eye movement recordings are not required. The HITT device is a repurposed Pediatric Vision Scanner (PVS), Rebion's first commercial product which has passed all applicable safety and performance standards. | Device | – |
Primary outcome
Capturing of wave forms from the eye
Time frame: Screenings will be performed during a normally scheduled visit to the sports facility by the research group enrolling in the study
Screening device will provide a wave form calculation of light reflecting off patient's eye
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Lockstadt, MD principal investigator
Bluegrass Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wave Form Signals Coming From the Eye in a Healthy Cohort, run by Rebiscan, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capturing of wave forms from the eye (time frame: Screenings will be performed during a normally scheduled visit to the sports facility by the research group enrolling in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.