Actively Recruiting
Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy
Led by University of Minnesota · Updated on 2025-12-02
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Minnesota
Lead Sponsor
H
Hennepin County Medical Center, Minneapolis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new device called a video ophthalmoscope to measure intracranial pressure (ICP) without invasive methods, anesthesia, or direct contact with the eye. The study focuses on conditions involving increased ICP, such as head injuries, brain edema, arachnoid cysts, craniosynostosis, and post-hemorrhagic hydrocephalus in very low birthweight infants. Current direct ICP monitoring methods involve surgical risks and anesthesia that can affect accuracy, so this study aims to provide a safer alternative. The study uses a custom video ophthalmoscope equipped with either a CCD or CMOS camera lens. The first phase involves 20 healthy participants to determine the optimal camera lens and to synchronize the video ophthalmoscope with other signals like ECG, PPG, intraocular pressure, and respiration. In the second phase, 70 patients with ICP probes are randomized into two groups: Group A will have two examinations spaced 1 to 14 days apart to estimate and verify ICP-related transfer functions, while Group B will have one examination for inter-group verification. Participants will be asked to sit still and focus their eyes on a target while the video ophthalmoscope records retinal images. The study will measure how well these recordings estimate intracranial pressure. Healthy controls and some verification participants will be enrolled for one day, while others may participate for up to 14 days. The research team will monitor and compare data from different examinations to assess the reliability of this non-invasive ICP measurement method.
CONDITIONS
Brief Title
Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be able to sit still and fix their eyes on a target in the video ophthalmoscope objective.
- Participants with intracranial pressure probes inserted for clinical purposes.
You will not qualify if you...
- Diagnosis of glaucoma.
- Diagnosis of retinopathy.
- Presence of head tremor.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days depending on group assignment
Participants undergo video ophthalmoscopy examinations using a custom device to record retinal videos and estimate intracranial pressure non-invasively without anesthesia or contact with the eye.
1 to 2 visits depending on group assignment
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
I
Igor Nestrasil, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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