Intracranial Pressure IncreaseICP WaveformNCT04046523
Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy
A study testing Video ophthalmoscope in people with Intracranial Pressure Increase, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Pressure Increase
- What is being tested?
- Video ophthalmoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of glaucoma, retinopathy or head tremor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Igor Nestrasil, MD, PhD, 612-625-0496, nestr007@umn.edu
About this study
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.
Read the 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
- Being tested
- Video ophthalmoscope
- Keywords
- video ophthalmoscope, intraocular pressure, electrocardiogram, photoplethysmography, retinal pulsatility, spontaneous venous pulsation, blind source separation
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video ophthalmoscopeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | 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. Receives: Device: Video ophthalmoscope |
| Transfer Function Estimation | Experimental | 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. Receives: Device: Video ophthalmoscope |
| Intra-Group Verification | Experimental | 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. Receives: Device: Video ophthalmoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study will look at whether retinal video-recordings can be used to help estimate intracranial pressure.
This study will help determine whether there could be a less invasive method of monitoring intracranial pressure. It is thought that the use of a video-ophthalmoscope recordings could be utilized to measure intracranial pressure. The outcome measures will be provided as z-scores.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start31 Jan 2023
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis, Minnesota Office of Higher Education
- Responsible party
- Sponsor
- Investigators
- Igor Nestrasil, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046523
- Sponsor's protocol ID
- PEDS-2019-28052
- Acronym
- ICP Waveform
- Status last verified
- Nov 2025
- First submitted
- 10 Jul 2019
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy
- ClinicalTrials.gov ID
- NCT04046523
- Acronym / sponsor ID
- ICP Waveform / PEDS-2019-28052
- Conditions
- Intracranial Pressure Increase
- Keywords
- video ophthalmoscope, intraocular pressure, electrocardiogram, photoplethysmography, retinal pulsatility, spontaneous venous pulsation, blind source separation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis, Minnesota Office of Higher Education
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Device: Video ophthalmoscopeIn 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. |
| Transfer Function Estimation | Experimental | Device: Video ophthalmoscopeSubjects 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. |
| Intra-Group Verification | Experimental | Device: Video ophthalmoscopeIndividuals 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. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Diagnosis of glaucoma, retinopathy or head tremor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video ophthalmoscopeUse 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. | Device | Healthy Controls, Intra-Group Verification, Transfer Function Estimation |
Primary outcome
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.
This study will help determine whether there could be a less invasive method of monitoring intracranial pressure. It is thought that the use of a video-ophthalmoscope recordings could be utilized to measure intracranial pressure. The outcome measures will be provided as z-scores.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Igor Nestrasil, MD, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video ophthalmoscope in people with Intracranial Pressure Increase, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Igor Nestrasil, MD, PhD (612-625-0496, nestr007@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.