Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Optic nerve head blood flow [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]

Вторичные конечные точки (11)

• Neurovascular coupling [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]
• Retinal nerve fiber layer thickness [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]
• Retinal and retinal layer thickness [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]
• Retinal vessel density [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]
• Choroidal vascularity index (EDI-OCT) [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]
• Retinal vessel diameter [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]
• Optic nerve head blood flow [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]
• Retinal oxygen extraction [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]
• Ocular perfusion pressure and arterial blood pressure [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]
• Retinal oxygen saturation [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]
• Choroidal thickness (EDI-OCT) [Срок оценки: Before the start of the therapy and 6 months after the start of the therapy]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Австрия · 1 центр

• Medical University of Vienna — Vienna

Публикации

• Markey KA, Mollan SP, Jensen RH, Sinclair AJ. Understanding idiopathic intracranial hypertension: mechanisms, management, and future directions. Lancet Neurol. 2016 Jan;15(1):78-91. doi: 10.1016/S1474-4422(15)00298-7. Epub 2015 Dec 8. PMID 26700907
• Pruckner P, Mitsch C, Macher S, Krajnc N, Marik W, Novak K, Wober C, Pemp B, Bsteh G. The Vienna idiopathic intracranial hypertension database-An Austrian registry. Wien Klin Wochenschr. 2024 Jan;136(1-2):32-39. doi: 10.1007/s00508-023-02252-x. Epub 2023 Aug 31. PMID 37650963
• Wang MTM, Bhatti MT, Danesh-Meyer HV. Idiopathic intracranial hypertension: Pathophysiology, diagnosis and management. J Clin Neurosci. 2022 Jan;95:172-179. doi: 10.1016/j.jocn.2021.11.029. Epub 2021 Dec 17. PMID 34929642
• Sugiyama T, Araie M, Riva CE, Schmetterer L, Orgul S. Use of laser speckle flowgraphy in ocular blood flow research. Acta Ophthalmol. 2010 Nov;88(7):723-9. doi: 10.1111/j.1755-3768.2009.01586.x. PMID 19725814
• Tamaki Y, Araie M, Tomita K, Nagahara M, Tomidokoro A, Fujii H. Real-time measurement of human optic nerve head and choroid circulation, using the laser speckle phenomenon. Jpn J Ophthalmol. 1997 Jan-Feb;41(1):49-54. doi: 10.1016/s0021-5155(96)00008-1. PMID 9147189
• Miller MM, Chang T, Keating R, Crouch E, Sable C. Blood flow velocities are reduced in the optic nerve of children with elevated intracranial pressure. J Child Neurol. 2009 Jan;24(1):30-5. doi: 10.1177/0883073808321050. PMID 19168816

Идентификаторы

NCT: NCT06545981 · OPHT-241123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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