Clinical trial NCT04046523: Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy
Official title: Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Pressure Increase
Keywords: video ophthalmoscope
intraocular pressure
electrocardiogram
photoplethysmography
retinal pulsatility
spontaneous venous pulsation
blind source separation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: In the first phase of the experiment, a total of 20 healthy controls will test the VO device to determine which camera is the most appropriate for ICP patients and to synchronize the VO, electrocardiogram (ECG), photoplethysmography (PPG), intraocular pressure (IOP) and respiratory signals.

The second phase of the experiment will enroll a total of 70 subjects who are undergoing ICP monitoring with a surgically placed probe will be randomly assigned into one of two groups. Each group will consist of 25 adult and 10 pediatric (aged 4-17) participants. Group A will undergo two inter-leaved examinations (up to 14 days apart). Data from the first exam will be used for SVP-ICP transfer function estimation and data from the second exam will serve for intra-group verification of the estimated transfer function. Group B participants will undergo only one examination and their data will serve as an inter-group re-test verification of the estimated transfer function.
Primary purpose: DIAGNOSTIC

Brief 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: 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.

Primary outcomes:
measure: The study will look at whether retinal video-recordings can be used to help estimate intracranial pressure.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Igor Nestrasil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: