NCT06545981 Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension
| NCT ID | NCT06545981 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Idiopathic Intracranial Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-05-28 |
| Primary Completion | 2026-05-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 48 participants in total. It began in 2024-05-28 with a primary completion date of 2026-05-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06545981 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Idiopathic Intracranial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06545981 currently recruiting?
Yes, NCT06545981 is actively recruiting participants. Contact the research team at gerhard.garhoefer@meduniwien.ac.at for enrollment information.
Where is the NCT06545981 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT06545981 clinical trial?
NCT06545981 is sponsored by Medical University of Vienna. The trial plans to enroll 48 participants.