Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension

Last updated: August 29, 2024
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Circulation Disorders

Williams Syndrome

Treatment

Lumbar puncture and administration of medication

Clinical Study ID

NCT06545981
OPHT-241123
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Lumbar puncture and administration of medication
Phase:
Study Start date:
May 28, 2024
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

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