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

NCT04046523 · University of Minnesota
In plain English

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About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 90 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2023-01-31
Estimated completion: 2030-07-31
Last updated: 2025-12-02
Interventions
Device: Video ophthalmoscope
Primary outcomes
  • The study will look at whether retinal video-recordings can be used to help estimate intracranial pressure. (Participants in the Healthy Control and Intra-Group Verification arms will be enrolled for one day. Transfer Function Estimation Subjects will be enrolled for up to 14 days.)
Sponsor
University of Minnesota · other
With: Hennepin County Medical Center, Minneapolis, Minnesota Office of Higher Education
Contacts & investigators
ContactIgor Nestrasil, MD, PhD · contact · nestr007@umn.edu · 612-625-0496
InvestigatorIgor Nestrasil, MD, PhD · principal_investigator, University of Minnesota
All locations (1)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy · TrialPath