Measuring eye‑vein pressure to estimate intracranial pressure
Official title: Investigation of a New Window Into Intracranial Pressure: Venous Occlusion Pressure of the Isolated Periorbital Vein
Run by University of Freiburg · NCT07053631 · Data updated 2026-11-12
This trial will try measuring pressure in a vein near the eye to see if it matches lumbar CSF pressure in adults scheduled for diagnostic CSF testing.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 95 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University of Freiburg Academic / other |
| Locations | 1 site (Freiburg im Breisgau) |
| Status | Recruiting |
| Started | April 7, 2025 |
| Main results expected | December 6, 2025 |
| Study ends | December 8, 2025 |
| Registry record updated | July 8, 2025 |
| Trial ID | NCT07053631 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–95 who are already scheduled for routine craniospinal dynamic CSF testing and can give informed consent are the intended participants.
✕Probably not a fit
People with altered CSF communication, prior CSF diversion procedures, recent (within 6 months) brain injury or transdural surgery, head wounds or hematomas that block the measurement site, or orbital conditions affecting venous outflow are unlikely to benefit from this method.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares a non-invasive venous occlusion pressure measurement of an isolated periorbital vein with standard invasive lumbar CSF pressure measurements in adults undergoing routine dynamic CSF testing. During the planned CSF testing, participants will lie in the lateral recumbent position while a pneumatic mask and periorbital vein measurement are applied alongside the routine invasive measurements. The non-invasive readings will be taken in parallel with invasive lumbar CSF pressure to determine agreement and to explore relationships with derivatives of dynamic CSF testing. Results will be analyzed to quantify how closely venous occlusion pressure corresponds to lumbar CSF pressure.
Why it matters
Potential benefit: If successful, this could provide a safer, non-invasive way to estimate intracranial pressure and reduce reliance on lumbar puncture or invasive monitoring.
How similar studies have gone: The periorbital venous occlusion approach is relatively novel with limited prior validation, while other non-invasive ICP proxies (such as optic nerve sheath diameter or transcranial Doppler) have shown mixed accuracy compared with invasive measures.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Medical indication to perform routine craniospinal CSF dynamic testing according to standard operative procedures * Aged 18-95 * Willing and able to provide valid signed informed consent Exclusion Criteria: * Patients with any known ongoing, or history of, abnormal CSF communication * Patients with any kind of prior intervention for CSF diversion * Patients with acute brain damage within the preceding 6 months * Patients with transdural surgery within the preceding 6 months * Head wounds or hematoma that could hinder access to measurement site * Any known pathological condition linked to the orbital socket influencing venous outflow
Where it's running
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Klinik für Neurochirurgie, Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany Recruiting
Study contacts
- Study coordinator: Katharina Wolf
- Email: katharina.wolf@uniklinik-freiburg.de
- Phone: +4976127050010
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.