Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension
Recruiting · NCT06545981 · Observational (researchers observe without assigning treatment) · Lead sponsor: Medical University of Vienna
View the official record on ClinicalTrials.gov →Interventions studied
Lumbar puncture and administration of medication
What this trial is about
The proposed study aims to evaluate optic nerve head blood flow and microcirculation in patients with idiopathic intracranial hypertension. For this purpose, optic nerve head blood flow will be examined in patients with IIH before and after therapy and additionally compared with healthy age- and sex-matched control subjects. In addition, other parameters will be measured, in particular retinal blood flow, retinal oxygen saturation and retinal neurovascular coupling.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
1 location listed.
- Medical University of Vienna - Vienna, Austria