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NCT04046523NARecruitingAccepts Healthy Volunteers

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

University of Minnesota

Start Date

1/31/2023

Completion Date

7/31/2030

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.

Eligibility Criteria

Age Range: 4 years to No maximum

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.

Interventions

DEVICE

Video ophthalmoscope

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Conditions

Intracranial Pressure Increase

Locations

University of Minnesota

Minneapolis, Minnesota 55455

United States