Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension
NCT Number: NCT06545981
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Idiopathic Intracranial Hypertension
Interventions: OTHER: Lumbar puncture and administration of medication
Sponsor: Medical University of Vienna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-28
Completion Date: 2026-08-31
Locations: Medical University of Vienna, Vienna, 1090, Austria

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.

Primary Outcome Measures: Optic nerve head blood flow, Change in optic nerve head blood flow in patients with idiopathic intracranial hypertension before and 6 months after therapy (LSFG)., Before the start of the therapy and 6 months after the start of the therapy
Secondary Outcome Measures: Neurovascular coupling, Change in neurovascular coupling in patients with idiopathic intracranial hypertension before and 6 months after therapy (Dynamic Vessel Analyzer, IMEDOS, Jena, Germany), Before the start of the therapy and 6 months after the start of the therapy|Retinal nerve fiber layer thickness, Change in retinal nerve fiber layer thickness in patients with idiopathic intracranial hypertension before and 6 months after therapy., Before the start of the therapy and 6 months after the start of the therapy|Retinal and retinal layer thickness, Change in retinal and retinal layer thickness in patients with idiopathic intracranial hypertension before and 6 months after therapy (OCT)., Before the start of the therapy and 6 months after the start of the therapy|Retinal vessel density, Change in retinal vessel density in patients with idiopathic intracranial hypertension before and 6 months after therapy (OCT-A)., Before the start of the therapy and 6 months after the start of the therapy|Choroidal vascularity index (EDI-OCT), Change in choroidal vascularity index (CVI is defined as the ratio of vascular luminal area (LA) to total choroidal area (TCA) and is presented as a percentage) in patients with idiopathic intracranial hypertension before and 6 months after therapy (EDI-OCT)., Before the start of the therapy and 6 months after the start of the therapy|Retinal vessel diameter, Change in retinal vessel diameter (µm) in patients with idiopathic intracranial hypertension before and 6 months after therapy (retinal oximetry)., Before the start of the therapy and 6 months after the start of the therapy|Optic nerve head blood flow, Change in optic nerve head blood flow in patients with idiopathic intracranial hypertension before and 6 months after therapy (LDF)., Before the start of the therapy and 6 months after the start of the therapy|Retinal oxygen extraction, Change in retinal oxygen extraction in patients with idiopathic intracranial hypertension before and 6 months after therapy (LSFG, retinal oximetry)., Before the start of the therapy and 6 months after the start of the therapy|Ocular perfusion pressure and arterial blood pressure, Change in ocular perfusion pressure and arterial blood pressure in patients with idiopathic intracranial hypertension before and 6 months after therapy., Before the start of the therapy and 6 months after the start of the therapy|Retinal oxygen saturation, Retinal oxygen saturation (SO2) in patients with idiopathic intracranial hypertension before and 6 months after therapy (retinal oximetry)., Before the start of the therapy and 6 months after the start of the therapy|Choroidal thickness (EDI-OCT), Change in choroidal thickness (µm) in patients with idiopathic intracranial hypertension before and 6 months after therapy (EDI-OCT)., Before the start of the therapy and 6 months after the start of the therapy