Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418753
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Oculogica, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Intracranial Pressure Increase Diagnostic Test: EyeBOX for ICP

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
single
subjects with abnormal intracranial pressure
 Diagnostic Test: EyeBOX for ICP
non-invasive ICP Score algorithm using eye-tracking data from the EyeBOX(TM) device, which tracks the movement of the pupils over time


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Provide written informed consent.
  2. Require placement of an ICP monitor or ventriculostomy catheter for clinical purposes.
  3. Be between the ages of 4 and 70 years old.
  4. Have baseline vision correctable to within 20/500 bilaterally.
  5. Have no prior history of ocular dysmotility.
  6. Be awake with spontaneous eye opening at the time when eye tracking is performed.

Exclusion Criteria:

  1. Have a prior history of strabismus, diplopia, or palsy of CN-III, IV or VI.
  2. Be blind (no light perception), have missing eyes, be unable to open their eyes.
  3. Have a prior history of ocular motility dysfunction.
  4. Have had extensive prior eye surgery.
  5. Have any physical or mental injury or baseline disability rendering task completion difficult.
  6. Be intoxicated or have blood alcohol level greater than 0.2.
  7. Be a prisoner or in the company of a police officer or law enforcement officer pending arrest.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418753


Contacts
Layout table for location contacts
Contact: Rosina Samadani, PhD (917) 302-4333 rosina@oculogica.com
Contact: Mark Stenoien (763) 203-1032 mark@oculogica.com

Locations
Layout table for location information
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Eric Jackson, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Alejandro Rabinstein, MD         
Sponsors and Collaborators
Oculogica, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Eric Jackson, MD Johns Hopkins University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Oculogica, Inc.
ClinicalTrials.gov Identifier: NCT03418753    
Other Study ID Numbers: ICP001
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Oculogica, Inc.:
noninvasive diagnosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases