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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single | subjects with abnormal intracranial pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyeBOX for ICP | Diagnostic Test | non-invasive ICP Score algorithm using eye-tracking data from the EyeBOX(TM) device, which tracks the movement of the pupils over time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity | EyeBOX assessment of abnormal ICP relative to invasive intracranial pressure monitor | from time of enrollment through the period that ICP monitoring is required for clinical purposes up to 104 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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The study will enroll pediatric and adult patients with abnormal ICP. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be considered for enrollment into the study. There will be no enrollment restrictions based on race, ethnic origin, gender, or pregnancy status and efforts will be made to ensure that the benefits and burdens of research participation are distributed in an equitable manner. Subjects must require ICP monitoring for clinical indications. At the time when eye tracking is performed all patients must be awake with spontaneous eye opening.
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| Name | Affiliation | Role |
|---|---|---|
| Eric Jackson, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28574312 | Background | Kolecki R, Dammavalam V, Bin Zahid A, Hubbard M, Choudhry O, Reyes M, Han B, Wang T, Papas PV, Adem A, North E, Gilbertson DT, Kondziolka D, Huang JH, Huang PP, Samadani U. Elevated intracranial pressure and reversible eye-tracking changes detected while viewing a film clip. J Neurosurg. 2018 Mar;128(3):811-818. doi: 10.3171/2016.12.JNS161265. Epub 2017 Jun 2. |
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| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Rochester |
| Minnesota |
| 55905 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |