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NCT Number: NCT06545981

Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar puncture and administration of medication

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.

Primary outcomes

  1. Optic nerve head blood flow

    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).

Secondary outcomes

  1. Neurovascular coupling

    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)

  2. Retinal nerve fiber layer thickness

    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.

  3. Retinal and retinal layer thickness

    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).

  4. Retinal vessel density

    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).

  5. Choroidal vascularity index (EDI-OCT)

    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).

  6. Retinal vessel diameter

    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).

  7. Optic nerve head blood flow

    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).

  8. Retinal oxygen extraction

    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).

  9. Ocular perfusion pressure and arterial blood pressure

    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.

  10. Retinal oxygen saturation

    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).

  11. Choroidal thickness (EDI-OCT)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Gerhard Garhöfer

CONTACT

[email protected]

+43 1 40400 29880

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Aug 30, 2024

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.

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