Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension
ConditionIdiopathic Intracranial Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorMedical University of Vienna
About this trial
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
This trial accepts healthy volunteersQualifiers
Men and Women aged ≥ 18 years
Signed informed consent
Newly diagnosed idiopathic intracranial hypertension or relapse of idiopathic intracranial hypertension
Non-Smokers
Disqualifiers
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
Trial population
A total of 48 patients will be included in the study: * Group 1: 24 subjects with idiopathic intracranial hypertension * Group 2: 24 age- and sex-matched control subjects
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Lumbar puncture and administration of medication
Other interventionPatients 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Idiopathic intracranial hypertension (Group 1)1 intervention
Group B: Healthy control subjects (Group 2)0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Before the start of the therapy and 6 months after the start of the therapySecondary outcomes
1
Neurovascular coupling
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 therapy2
Retinal nerve fiber layer thickness
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 therapy3
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).
Time frame
Before the start of the therapy and 6 months after the start of the therapy4
Retinal vessel density
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 therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov