Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

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 Overview

• Status: Completed
• Conditions: Intracranial Pressure Increase
• Intervention / Treatment: Diagnostic test: EyeBOX for ICP

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

• Study Contact: Name: Rosina Samadani, PhD; Phone Number: (917) 302-4333; Email: rosina@oculogica.com
• Study Contact Backup: Name: Viridiana Juarez; Phone Number: 484-393-2694; Email: viridiana@oculogica.com

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity	EyeBOX assessment of abnormal ICP relative to invasive intracranial pressure monitor	from time of enrollment through the period that ICP monitoring is required for clinical purposes up to 104 weeks

Collaborators and Investigators

• Sponsor: Oculogica, Inc.
• Investigators: Principal Investigator: Eric Jackson, MD, Johns Hopkins University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: noninvasive diagnosis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension
• Other Study ID Numbers: ICP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No