Trials / Completed
CompletedNCT03418753
Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Oculogica, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 70 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-05-10
- Primary completion
- 2023-05-10
- Completion
- 2023-05-10
- First posted
- 2018-02-01
- Last updated
- 2023-09-07
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03418753. Inclusion in this directory is not an endorsement.