Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-28

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Idiopathic Intracranial Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Idiopathic intracranial hypertension (Group 1)

24 subjects with idiopathic intracranial hypertension

Lumbar puncture and administration of medication

Intervention Type OTHER

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.

Healthy control subjects (Group 2)

24 age- and sex-matched control subjects

No interventions assigned to this group

Interventions

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Lumbar 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and Women aged ≥ 18 years
* Signed informed consent
* Newly diagnosed idiopathic intracranial hypertension or relapse of idiopathic intracranial hypertension
* Non-Smokers

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes