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OpenTrials
Completed

NCT Number: NCT03418753

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.

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Key information

Conditions

Intracranial Pressure Increase Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases

Age range

4 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

EyeBOX for ICP

Diagnostic Test

non-invasive ICP Score algorithm using eye-tracking data from the EyeBOX(TM) device, which tracks the movement of the pupils over time

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oculogica, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2018
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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