Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

Oculogica, Inc.60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Intracranial Pressure Increase

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (3)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Sensitivity and Specificity

EyeBOX assessment of abnormal ICP relative to invasive intracranial pressure monitor

Time frame: from time of enrollment through the period that ICP monitoring is required for clinical purposes up to 104 weeks

Data from ClinicalTrials.gov

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