Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 4 - 70 |
| Updated: | 8/31/2018 |
| Start Date: | May 10, 2018 |
| End Date: | May 2021 |
| Contact: | Rosina Samadani, PhD |
| Email: | rosina@oculogica.com |
| Phone: | (917) 302-4333 |
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.
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.
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.
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