Intracranial Pressure IncreaseNCT03418753
Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure
An observational study of Intracranial Pressure Increase, run by Oculogica, Inc. at 3 sites in United States.
Trial summary
The study is a prospective, multi-center, non-randomized, open label observational study. The objective of this study is to compare the accuracy of the EyeBOX to a clinical diagnosis of abnormal ICP as determined by an external ventriculostomy drain (EVD) or ventriculostomy catheter. Read more about this study
- Who is it for?
- Ages 4 to 70 years
- Conditions the study is for
- Intracranial Pressure Increase
- What is being tested?
- EyeBOX for ICP
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 May 2018to 10 May 2023
- 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 4 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: The study will enroll pediatric and adult patients with abnormal ICP. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be considered for enrollment into the study. There will be no enrollment restrictions based on race, ethnic origin, gender, or pregnancy status and efforts will be made to ensure that the benefits and burdens of research participation are distributed in an equitable manner. Subjects must require ICP monitoring for clinical indications. At the time when eye tracking is performed all patients must be awake with spontaneous eye opening.
Who may be able to join
- Provide written informed consent.
- Require placement of an ICP monitor or ventriculostomy catheter for clinical purposes.
- Be between the ages of 4 and 70 years old.
- Have baseline vision correctable to within 20/500 bilaterally.
- Have no prior history of ocular dysmotility.
- Be awake with spontaneous eye opening at the time when eye tracking is performed.
Who cannot join
- Have a prior history of strabismus, diplopia, or palsy of CN-III, IV or VI.
- Be blind (no light perception), have missing eyes, be unable to open their eyes.
- Have a prior history of ocular motility dysfunction.
- Have had extensive prior eye surgery.
- Have any physical or mental injury or baseline disability rendering task completion difficult.
- Be intoxicated or have blood alcohol level greater than 0.2.
- Be a prisoner or in the company of a police officer or law enforcement officer pending arrest.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
About this study
The study is a prospective, multi-center, non-randomized, open label observational study. The objective of this study is to compare the accuracy of the EyeBOX to a clinical diagnosis of abnormal ICP as determined by an external ventriculostomy drain (EVD) or ventriculostomy catheter.
- Conditions
- Intracranial Pressure Increase
- Being tested
- EyeBOX for ICP
- Keywords
- noninvasive diagnosis
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeBOX for ICPDiagnostic test
non-invasive ICP Score algorithm using eye-tracking data from the EyeBOX(TM) device, which tracks the movement of the pupils over time
| Study group | Role | What they receive |
|---|---|---|
| single | subjects with abnormal intracranial pressure Receives: Diagnostic Test: EyeBOX for ICP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
EyeBOX assessment of abnormal ICP relative to invasive intracranial pressure monitor
Measured: from time of enrollment through the period that ICP monitoring is required for clinical purposes up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start10 May 2018
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial Pressure IncreaseStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oculogica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Jackson, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418753
- Sponsor's protocol ID
- ICP001
- Status last verified
- Aug 2023
- First submitted
- 17 Jan 2018
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kolecki R, Dammavalam V, Bin Zahid A, Hubbard M, Choudhry O, Reyes M, Han B, Wang T, Papas PV, Adem A, North E, Gilbertson DT, Kondziolka D, Huang JH, Huang PP, Samadani U. Elevated intracranial pressure and reversible eye-tracking changes detected while viewing a film clip. J Neurosurg. 2018 Mar;128(3):811-818. doi: 10.3171/2016.12.JNS161265. Epub 2017 Jun 2.
PubMed 28574312
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure
- ClinicalTrials.gov ID
- NCT03418753
- Acronym / sponsor ID
- ICP001
- Conditions
- Intracranial Pressure Increase
- Keywords
- noninvasive diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oculogica, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2018 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 1 Feb 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.
The study is a prospective, multi-center, non-randomized, open label observational study. The objective of this study is to compare the accuracy of the EyeBOX to a clinical diagnosis of abnormal ICP as determined by an external ventriculostomy drain (EVD) or ventriculostomy catheter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single | – | Diagnostic Test: EyeBOX for ICPsubjects with abnormal intracranial pressure |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study will enroll pediatric and adult patients with abnormal ICP. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be considered for enrollment into the study. There will be no enrollment restrictions based on race, ethnic origin, gender, or pregnancy status and efforts will be made to ensure that the benefits and burdens of research participation are distributed in an equitable manner. Subjects must require ICP monitoring for clinical indications. At the time when eye tracking is performed all patients must be awake with spontaneous eye opening.
Key inclusion criteria (6 listed)
- Provide written informed consent.
- Require placement of an ICP monitor or ventriculostomy catheter for clinical purposes.
- Be between the ages of 4 and 70 years old.
- Have baseline vision correctable to within 20/500 bilaterally.
- Have no prior history of ocular dysmotility.
Key exclusion criteria (7 listed)
- Have a prior history of strabismus, diplopia, or palsy of CN-III, IV or VI.
- Be blind (no light perception), have missing eyes, be unable to open their eyes.
- Have a prior history of ocular motility dysfunction.
- Have had extensive prior eye surgery.
- Have any physical or mental injury or baseline disability rendering task completion difficult.
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 |
|---|---|---|
| EyeBOX for ICPnon-invasive ICP Score algorithm using eye-tracking data from the EyeBOX(TM) device, which tracks the movement of the pupils over time | Diagnostic test | single |
Primary outcome
Sensitivity and Specificity
Time frame: from time of enrollment through the period that ICP monitoring is required for clinical purposes up to 104 weeks
EyeBOX assessment of abnormal ICP relative to invasive intracranial pressure monitor
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 7 Sep 2023.
- Background: PubMed 28574312Kolecki R, Dammavalam V, Bin Zahid A, Hubbard M, Choudhry O, Reyes M, Han B, Wang T, Papas PV, Adem A, North E, Gilbertson DT, Kondziolka D, Huang JH, Huang PP, Samadani U. Elevated intracranial pressure and reversible eye-tracking changes detected while viewing a film clip. J Neurosurg. 2018 Mar;128(3):811-818. doi: 10.3171/2016.12.JNS161265. Epub 2017 Jun 2.
- Individual participant dataSharing planned: No
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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.
Eric Jackson, MD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure Increase, run by Oculogica, Inc. at 3 sites 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 6 inclusion and 7 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Sensitivity and Specificity (time frame: from time of enrollment through the period that ICP monitoring is required for clinical purposes up to 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03418753, which also lists 1 linked publication.
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 7 Sep 2023.