Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension

Medical University of Vienna

Status

Enrolling

Conditions

Idiopathic Intracranial Hypertension

Treatments

Other: Lumbar puncture and administration of medication

Study type

Observational

Funder types

Other

Identifiers

NCT06545981

OPHT-241123

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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