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

ConditionIntracranial Pressure Increase

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age4+

SponsorUniversity of Minnesota

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Diagnosis of glaucoma, retinopathy or head tremor.

Trial design

Design model

Factorial

Treatments tested in this trial

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.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Healthy ControlsExperimental treatment 1 intervention

Group B: Transfer Function EstimationExperimental treatment 1 intervention

Group C: Intra-Group VerificationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

The study will look at whether retinal video-recordings can be used to help estimate intracranial pressure.

This study will help determine whether there could be a less invasive method of monitoring intracranial pressure. It is thought that the use of a video-ophthalmoscope recordings could be utilized to measure intracranial pressure. The outcome measures will be provided as z-scores.

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Hennepin County Medical Center, Minneapolis

Collaborator

Minnesota Office of Higher Education

Collaborator

Source ClinicalTrials.gov

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