Status:
COMPLETED
Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure
Lead Sponsor:
Oculogica, Inc.
Conditions:
Intracranial Pressure Increase
Eligibility:
All Genders
4-70 years
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 10 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03418753
Start Date
May 10 2018
End Date
May 10 2023
Last Update
September 7 2023
Active Locations (3)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104