Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Video ophthalmoscope.
- Who it may be relevant to
- Registry conditions: Intracranial Pressure Increase. Basic parameters: from 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT04046523 · PEDS-2019-28052