Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

Completed

• Conditions: Intracranial Pressure Increase
• Interventions: Diagnostic Test: EyeBOX for ICP

• Registration Number: NCT03418753
• Lead Sponsor: Oculogica, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-02-01
• Study Start: 2018-05-10
• Primary Completion: 2023-05-10
• Study Completion: 2023-05-10
• Status Verified: 2023-08
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single	EyeBOX for ICP	subjects with abnormal intracranial pressure

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	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

Trial Locations

Locations (3)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States