Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension
- Conditions
- Idiopathic Intracranial Hypertension
- Interventions
- Other: Lumbar puncture and administration of medication
- Registration Number
- NCT06545981
- Lead Sponsor
- Medical University of Vienna
- 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.
- Detailed Description
Idiopathic intracranial hypertension (IIH) is a neuroophthalmological disease, characterized by an increased intracranial pressure (ICP) without an identifiable causative factor. If not properly treated and carefully monitored the disease can even lead to irreversible severe or complete loss of vision or severe irreversible visual field defects, respectively. Given this clinical urgency, precise diagnostic tools become essential for timely decision making.
Laser Speckle Flowgraphy (LSFG) is a non-invasive, in-vivo imaging method, which quantitatively estimates blood flow in the optic nerve head, the choroid, the retina and the iris. LSFG has a low procedural complexity, obtains precise and reproducible measurements and is therefore suitable to assess ocular perfusion.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Idiopathic intracranial hypertension (Group 1) Lumbar puncture and administration of medication 24 subjects with idiopathic intracranial hypertension
- Primary Outcome Measures
Name Time Method Optic nerve head blood flow Before the start of the therapy and 6 months after the start of the therapy Change in optic nerve head blood flow in patients with idiopathic intracranial hypertension before and 6 months after therapy (LSFG).
- Secondary Outcome Measures
Name Time Method Neurovascular coupling Before the start of the therapy and 6 months after the start of the therapy Change in neurovascular coupling in patients with idiopathic intracranial hypertension before and 6 months after therapy (Dynamic Vessel Analyzer, IMEDOS, Jena, Germany)
Retinal nerve fiber layer thickness Before the start of the therapy and 6 months after the start of the therapy Change in retinal nerve fiber layer thickness in patients with idiopathic intracranial hypertension before and 6 months after therapy.
Retinal and retinal layer thickness Before the start of the therapy and 6 months after the start of the therapy Change in retinal and retinal layer thickness in patients with idiopathic intracranial hypertension before and 6 months after therapy (OCT).
Retinal vessel diameter Before the start of the therapy and 6 months after the start of the therapy Change in retinal vessel diameter (µm) in patients with idiopathic intracranial hypertension before and 6 months after therapy (retinal oximetry).
Retinal oxygen saturation Before the start of the therapy and 6 months after the start of the therapy Retinal oxygen saturation (SO2) in patients with idiopathic intracranial hypertension before and 6 months after therapy (retinal oximetry).
Retinal vessel density Before the start of the therapy and 6 months after the start of the therapy Change in retinal vessel density in patients with idiopathic intracranial hypertension before and 6 months after therapy (OCT-A).
Optic nerve head blood flow Before the start of the therapy and 6 months after the start of the therapy Change in optic nerve head blood flow in patients with idiopathic intracranial hypertension before and 6 months after therapy (LDF).
Choroidal vascularity index (EDI-OCT) Before the start of the therapy and 6 months after the start of the therapy 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).
Retinal oxygen extraction Before the start of the therapy and 6 months after the start of the therapy Change in retinal oxygen extraction in patients with idiopathic intracranial hypertension before and 6 months after therapy (LSFG, retinal oximetry).
Ocular perfusion pressure and arterial blood pressure Before the start of the therapy and 6 months after the start of the therapy Change in ocular perfusion pressure and arterial blood pressure in patients with idiopathic intracranial hypertension before and 6 months after therapy.
Choroidal thickness (EDI-OCT) Before the start of the therapy and 6 months after the start of the therapy Change in choroidal thickness (µm) in patients with idiopathic intracranial hypertension before and 6 months after therapy (EDI-OCT).
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria