[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100366073":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":53,"collaborators":55,"id":61,"slug":28,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":28,"enrollmentInfo":70,"targetDuration":28,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":40,"whyStopped":28,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Minnesota","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Controls","EXPERIMENTAL","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.",[13],"Device: Video ophthalmoscope",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"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.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"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.",[9,19,15],null,[30],{"name":31,"affiliation":5,"role":32},"Igor Nestrasil, MD, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":37},"CONTACT","612-625-0496","nestr007@umn.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Minneapolis","Minnesota","55455","United States",{"type":46,"coordinates":47},"Point",[48,49],-93.26384,44.97997,{"lat":49,"lon":48},[52],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":37},{"type":54,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[56,58],{"name":57,"class":6},"Hennepin County Medical Center, Minneapolis",{"name":59,"class":60},"Minnesota Office of Higher Education","OTHER_GOV","100366073",false,"NCT04046523","Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy","ICP Waveform","Inclusion Criteria:\n\n* Must be able to sit still and fix their eyes on a target in the VO objective.\n* ICP participants must have an inserted ICP probe for clinical purposes.\n\nExclusion Criteria:\n\n* Diagnosis of glaucoma, retinopathy or head tremor.",true,"ALL","4 Years",{"count":71,"type":72},90,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.",[78],"Intracranial Pressure Increase",[80,81,82,83,84,85,86],"video ophthalmoscope","intraocular pressure","electrocardiogram","photoplethysmography","retinal pulsatility","spontaneous venous pulsation","blind source separation","2025-11-24",{"date":89,"type":90},"2025-12-02","ACTUAL",{"date":92,"type":90},"2023-01-31",{"date":94,"type":72},"2030-07-31",{"name":5,"class":6},1]