Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Healthy Volunteers: t
View:
• 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.
Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Igor Nestrasil, MD, PhD
nestr007@umn.edu
612-625-0496
Time Frame
Start Date: 2019-08-31
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 90
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Minnesota Office of Higher Education, Hennepin County Medical Center, Minneapolis
Leads: University of Minnesota