Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

Oculogica

Status: Completed

Conditions: Intracranial Pressure Increase

Treatments: Diagnostic Test: EyeBOX for ICP

Study type: Observational

Funder types: Industry

Identifiers

NCT03418753

ICP001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 4 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

single

Description:

subjects with abnormal intracranial pressure

Treatment:

Diagnostic Test: EyeBOX for ICP