Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy

  • STATUS
    Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    90
  • sponsor
    University of Minnesota
Updated on 9 September 2021

Summary

This study will test the use of video ophthalmoscope to provide information about intracranial pressure without the use of invasive methods, anesthesia or contact with the eye.

Description

The monitoring of intracranial pressure (ICP) is crucial in head injuries and pathologies such as brain edema, arachnoid cyst, craniosynostosis or, in very-low-birthweight infants, post-hemorrhagic hydrocephalus. Some current methods of ICP are invasive and, in the case of lumbar puncture, require anesthesia, which can distort the measurement by 5-10 mmHg. The golden clinical standard is direct measurement using a surgically-implanted intraventricular drain connected to an external pressure transducer ("ICP probe"). However, this method carries risks such as hemorrhage, malfunction, obstruction or infection . The risk in pediatric patients is up to 5% and in adults the risk of fatal hemorrhage is 4-5% in patients with subdural and intraparenchymal monitoring devices. Due to these risks and the financial burden on patients, there have been attempts to develop tools for non-invasive ICP estimation. This study will test the use of a video ophthalmoscope that will calculate the relative waveform of intracranial pressure and provide information about intracranial compliance without the use of anesthesia, invasive methods or contact with the eye.

Details
Condition Increased intracranial pressure
Treatment Video ophthalmoscope
Clinical Study IdentifierNCT04046523
SponsorUniversity of Minnesota
Last Modified on9 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must be able to sit still and fix their eyes on a target in the VO objective
ICP participants must have an inserted ICP probe for clinical purposes

Exclusion Criteria

Diagnosis of glaucoma, retinopathy or head tremor
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