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NCT Number: NCT04046523

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

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.

Recruiting

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Key information

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Igor Nestrasil, MD, PhD

CONTACT

[email protected]

612-625-0496

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video ophthalmoscope

Device

Use of a custom video ophthalmoscope with either a CCD or CMOS camera lens. The healthy controls group (first 20 subjects) will provide data to help determine which lens might be best for measuring ICP patients (Groups A and B) in the second phase of the study.

Primary outcomes

  1. The study will look at whether retinal video-recordings can be used to help estimate intracranial pressure.

    Time frame: 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.

    This study will help determine whether there could be a less invasive method of monitoring intracranial pressure. It is thought that the use of a video-ophthalmoscope recordings could be utilized to measure intracranial pressure. The outcome measures will be provided as z-scores.

Study contacts

Contact information is provided by the study sponsor or research team.

Igor Nestrasil, MD, PhD

CONTACT

[email protected]

612-625-0496

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Hennepin County Medical Center, Minneapolis
  • Minnesota Office of Higher Education

Registry information

Acronym: ICP Waveform

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Aug 6, 2019
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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