Medical University of Vienna
Vienna, 1090, Austria
Location status: Recruiting
NCT Number: NCT06545981
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Vienna, 1090, Austria
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patients with idiopathic intracranial hypertension
Inclusion criteria
for healthy age- and sex-matched control subjects
Exclusion criteria
for patients with idiopathic intracranial hypertension and healthy age- and sex-matched control subjects:
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.
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Medical University of Vienna
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06856850
ALS (Amyotrophic Lateral Sclerosis), Amyotrophic Lateral Sclerosis
Milan, Italy
View Trial DetailsNCT06855342
Brain Diseases, Central Nervous System Diseases
London, United Kingdom
View Trial DetailsNCT07707544
Brain Diseases, Central Nervous System Diseases
Sohag, Sohag Governorate, Egypt
View Trial DetailsNCT03096743
Brain Diseases, Central Nervous System Diseases
Rochester, Minnesota, United States
View Trial Details