Estimation of Intracranial Pressure Using Non-invasive Fundus Videos

NCT03382860 | Unknown DMC

• 2 other identifiers: S-201700382012-58-0018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Pressure

Keywords

Intracranial Hypertension; Intracranial pressure monitoring; Non-invasive point-of-care device; Normal pressure hydrocephalus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in A/V ratio value compared to increased intracranial pressure monitor during infusion test.

  2025

Study Arms (2)

Ventriculoperitoneal dysfunction

Patients with suspected ventriculo-peritoneal (VP) shunt dysfunction are admitted to the neurosurgical department for intracranial pressure monitoring for 24 hours. The patients are approached within this time frame.

Diagnostic Test: Fundus videos

Normal Pressure Hydrocephalus (NPH)

Patients with suspected NPH (triad of cognitive dysfunction, urine incontinence of urge type, abnormal gait) are admitted to the neurosurgical department for intracranial pressure monitoring for 24 hours. The following day an infusiontest is performed, where data is collected.

Diagnostic Test: Fundus videos

Interventions

Fundus videos DIAGNOSTIC_TEST

Recordings of fundus videos

Normal Pressure Hydrocephalus (NPH); Ventriculoperitoneal dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All conscious and able patients of 18 years and older admitted for intracranial pressure monitoring in the department of neurosurgery (Camino, Integra, Switzerland)

You may qualify if:

• 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

You may not qualify if:

• Disabled and unconscious
• No intraparenchymal or intraventricular ICP monitoring

Sponsors & Collaborators

• Odense University Hospital: lead
• Statumanu Icp ApS: collaborator

Study Sites (1)

Department of Neurosurgery, Odense University Hospital

Odense C, Danmark, 5000, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 32747697 RESULT

Related Links

• Biomechanics of Retinal Venous Pulsations as Indicators of Intracranial Pressure

MeSH Terms

Conditions

Intracranial Hypertension; Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, MD

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: June 1, 2017
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

DK (1)