Intracranial Pressure Clinical Trial
Official title:
Estimation of Intracranial Pressure Using Non-invasive Fundus Videos
Verified date | May 2023 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this pilot study is to assess whether the intracranial pressure (ICP) can be detected by using a non-invasive retinal fundus scanner, recording the vessels of the eye entering from the optic disc. The artery's diameter (A) is measured and compared to the vein's diameter (V) thereby a ratio A/V can be calculated. This ratio is compared to the values obtained from conventional fiberoptic intraparenchymal, intraventricular ICP monitoring using external ventricular drain (EVD) or lumbar pressure monitoring. Valid non-invasive techniques for objective measurements of the intracranial pressure do not exist at the given time now and this study could prove to help the development of monitoring patients ICP without surgical intervention.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults 18 years or older with indication for intraparenchymal or intraventricular ICP monitoring - Conscious and able - Admission to the Department of Neurosurgery or Department of Neurology at Odense University Hospital Exclusion Criteria: - Disabled and unconscious - No intraparenchymal or intraventricular ICP monitoring |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Neurosurgery, Odense University Hospital | Odense C | Danmark |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital | Statumanu Icp ApS |
Denmark,
Andersen MS, Pedersen CB, Poulsen FR. A new novel method for assessing intracranial pressure using non-invasive fundus images: a pilot study. Sci Rep. 2020 Aug 3;10(1):13062. doi: 10.1038/s41598-020-70084-0. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute A/V ratio value to conventional intracranial pressure monitors | Comparison of A/V ratio values from the fundus video analysis and conventional intraparenchymal intracranial pressure (ICP), intraventricular ICP monitoring or lumbar pressure monitoring. | 2025 | |
Secondary | Change in A/V ratio value compared to increased intracranial pressure monitor during infusion test. | Assessment of the use of the fundus videos in patients undergoing a lumbar infusion test for 20 minutes for assessment of normal intracranial pressure compared to a conventional intraparenchymal ICP monitor. | 2025 |
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