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

Conditions

• Intracranial Pressure Increase

Eligibility Criteria

Sex

ALL

Age

4 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Video ophthalmoscope — DEVICE
  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 Details

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.

Key Dates

Start date

Jan 31, 2023

Status verified

Nov 2025

Primary completion

Jul 31, 2029

Completion

Jul 31, 2030

Study Design

Enrollment

90 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

DIAGNOSTIC

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.

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

• Igor Nestrasil, MD, PhD
  612-625-0496
  [email protected]

Locations (1)

Find similar trials in Minneapolis, MN

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