NCT04046523

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Intracranial Pressure Increase

Interventions

Type	Name	Description
DEVICE	Video ophthalmoscope	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.

Timeline

• Start date: 2023-01-31
• Primary completion: 2029-07-31
• Completion: 2030-07-31
• First posted: 2019-08-06
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States