Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT04046523

Conditions

Intracranial Pressure Increase

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

Interventions

Video ophthalmoscope

Study Details

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.

Conditions

Intracranial Pressure Increase

Study ID

NCT04046523

Start date

Jan 31, 2023

Status verified date

Nov, 2025

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Healthy Controls

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.

experimental: Transfer Function Estimation

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.

experimental: Intra-Group Verification

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.

Interventions

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 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. ]

Central Contacts and Locations

Central contacts

Igor Nestrasil, MD, PhD

612-625-0496nestr007@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Igor Nestrasil, MD, PhD

612-625-0496nestr007@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Keywords

  • video ophthalmoscope
  • intraocular pressure
  • electrocardiogram
  • photoplethysmography
  • retinal pulsatility
  • spontaneous venous pulsation
  • blind source separation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-12-02.