MedTrace Logo

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

NCT04046523 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hennepin County Medical Center, Minneapolis

    collaborator OTHER

  • Minnesota Office of Higher Education

    collaborator OTHER_GOV

  • University of Minnesota

    lead OTHER

Principal Investigators

  • Igor Nestrasil, MD, PhD · University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2029-07-31
Completion
2030-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046523 on ClinicalTrials.gov