Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

The subject or their legally authorized representative must provide written informed consent.
Subject must require placement of an ICP monitor (intraparenchymal strain gauge or fiberoptic monitor, or ventriculostomy catheter) for clinical purposes.
Subject must be between the ages of 4 and 70 years old.
Subject must be awake with spontaneous eye opening at the time when eye tracking is performed.

Exclusion Criteria

Subjects must not be blind (no light perception), have missing eyes, be unable to open their eyes.
Subjects may not have a prior history of ocular motility dysfunction; including strabismus; diplopia; palsy of CN III, CN IV, or CN VI; optic neuropathy; macular edema; retinal degeneration.
Subjects may not have had extensive prior eye surgery.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Alejandro Rabinstein, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Alejandro Rabinstein, M.D.

Closed for enrollment

More information

Publications

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