Evaluating blood flow in the optic nerve of patients with idiopathic intracranial hypertension

Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension

This study is testing how blood flows in the optic nerve of people with idiopathic intracranial hypertension to see if it changes with treatment and how it compares to healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 48 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Medical University of Vienna (Academic / other)
• Locations: 1 site (Vienna)
• Trial ID: NCT06545981 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess optic nerve head blood flow and microcirculation in patients diagnosed with idiopathic intracranial hypertension (IIH). Using a non-invasive imaging technique called Laser Speckle Flowgraphy (LSFG), the study will measure blood flow before and after therapy and compare these results with healthy control subjects. Additional parameters such as retinal blood flow, oxygen saturation, and neurovascular coupling will also be evaluated to enhance understanding of ocular perfusion in IIH. The study is crucial for developing precise diagnostic tools for timely treatment decisions in patients at risk of vision loss.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 18 and older with newly diagnosed or relapsed idiopathic intracranial hypertension who are non-smokers.

Not a fit: Patients with significant ocular inflammation, infection, or other clinically relevant illnesses in the three weeks prior to the study may not benefit from participation.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic methods and treatment strategies for patients with idiopathic intracranial hypertension, potentially preserving vision.

How similar studies have performed: While the approach using LSFG is established, the specific application to IIH is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion criteria for patients with idiopathic intracranial hypertension

* Men and Women aged ≥ 18 years
* Signed informed consent
* Newly diagnosed idiopathic intracranial hypertension or relapse of idiopathic intracranial hypertension
* Non-Smokers

Inclusion criteria for healthy age- and sex-matched control subjects

* Men and Women aged ≥ 18 years
* Signed informed consent
* Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the medical history, unless the investigator considers an abnormality to be clinically irrelevant
* Non-Smokers

Exclusion criteria for patients with idiopathic intracranial hypertension and healthy age- and sex-matched control subjects:

* Blood donation in the three weeks preceding the study
* Symptoms of a clinically relevant illness in the three weeks preceding the study
* Ocular inflammation or infection within the last 3 months
* History or family history of epilepsy
* Diabetes mellitus type 1 or type 2
* History or known presence of other cerebral vascular diseases (e.g.: arteriovenous malformation, aneurysm, major artery stenosis or occlusion)
* History or known presence of intracranial infections (e.g.: meningitis)
* History or known presence of other neurological diseases (e.g.: brain tumor, hydrocephalus, degenerative diseases)
* Patients receiving corticosteroids or immunosuppressant therapy
* Pregnant or breast-feeding women
* Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception

Where this trial is running

Vienna

• Medical University of Vienna — Vienna, Austria (Recruiting)

Study contacts

• Study coordinator: Gerhard Garhöfer

Conditions Idiopathic Intracranial Hypertension