Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-10

Study Completion Date

2023-05-10

Brief Summary

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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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Detailed Description

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Conditions

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Intracranial Pressure Increase

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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single

subjects with abnormal intracranial pressure

EyeBOX for ICP

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No