NCT03418753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 10, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

September 7, 2023

Status Verified

August 1, 2023

Enrollment Period

5 years

First QC Date

January 17, 2018

Last Update Submit

September 5, 2023

Conditions

Intracranial Pressure Increase

Keywords

noninvasive diagnosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

single

subjects with abnormal intracranial pressure

Diagnostic Test: EyeBOX for ICP

Interventions

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

single

Eligibility Criteria

Age4 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 28574312BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Eric Jackson, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

February 1, 2018

Study Start

May 10, 2018

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

September 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)