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Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

NCT03418753 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-09-07

No results posted yet for this study

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.

Conditions

  • Intracranial Pressure Increase

Interventions

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

Sponsors & Collaborators

  • Oculogica, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Jackson, MD · Johns Hopkins University

Eligibility

Min Age
4 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-10
Primary Completion
2023-05-10
Completion
2023-05-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03418753 on ClinicalTrials.gov