Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

Intracranial Pressure Increase Clinical Trial

Official title:

Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418753
• Other study ID #: ICP001
• Status: Completed
• Start date: May 10, 2018
• Est. completion date: May 10, 2023

Study information

• Verified date: August 2023
• Source: Oculogica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 10, 2023
• Est. primary completion date: May 10, 2023
• Gender: All
• Age group: 4 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intracranial Hypertension
• Intracranial Pressure Increase

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Oculogica, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kolecki R, Dammavalam V, Bin Zahid A, Hubbard M, Choudhry O, Reyes M, Han B, Wang T, Papas PV, Adem A, North E, Gilbertson DT, Kondziolka D, Huang JH, Huang PP, Samadani U. Elevated intracranial pressure and reversible eye-tracking changes detected while viewing a film clip. J Neurosurg. 2018 Mar;128(3):811-818. doi: 10.3171/2016.12.JNS161265. Epub 2017 Jun 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity	EyeBOX assessment of abnormal ICP relative to invasive intracranial pressure monitor	from time of enrollment through the period that ICP monitoring is required for clinical purposes up to 104 weeks