Idiopathic Intracranial Hypertension
Conditions
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.
Interventions
OTHERLumbar puncture and administration of medication
Patients with idiopathic intracranial hypertension will receive lumbar puncture and will be given medication to reduce intracranial pressure by neurologists. The lumbar puncture and the administration of medication are not part of this study, patients would also receive these without participating in the study.
Sponsors
Medical University of Vienna
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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). |
| 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). |
| 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). |
| 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. |
| 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 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). |
Countries
Austria
Contacts
Primary ContactGerhard Garhöfer
Outcome results
None listed