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

University of Minnesota (UMN)

Status: Enrolling

Conditions: Intracranial Pressure Increase

Treatments: Device: Video ophthalmoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT04046523

PEDS-2019-28052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Healthy Controls

Experimental group

Description:

In the first phase of the experiment, 20 healthy controls will test the VO device to determine whether the camera with a CCD or CMOS lens is the most appropriate for use in ICP patients and to synchronize the VO, ECG, PPG, IOP and respiratory signals.

Treatment:

Device: Video ophthalmoscope

Transfer Function Estimation

Experimental group

Description:

Subjects in the second phase of the experiment (70 subjects total) will be randomized to either Group A or Group B. We anticipate that 25 adult and 10 pediatric (ages 4-17) patients will participate in each group. Individuals in Group A will have two inter-leaved examinations (1-14 days apart). Data from the first examination will serve for SVP-ICP transfer function estimation and data from the second examination will serve for the intra-group verification for the estimated transfer function.

Treatment:

Device: Video ophthalmoscope

Intra-Group Verification

Experimental group

Description:

Individuals in Group B will undergo one examination. Data from Group B participants will serve as the inter-group re-test verification of the estimated transfer function.

Treatment:

Device: Video ophthalmoscope