Clinical trial NCT06545981: Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension
Official title: Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Intracranial Hypertension
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 48 patients will be included in the study:

* Group 1: 24 subjects with idiopathic intracranial hypertension
* Group 2: 24 age- and sex-matched control subjects

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Optic nerve head blood flow
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
Secondary outcomes:
measure: Neurovascular coupling
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
measure: Retinal nerve fiber layer thickness
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
measure: Retinal and retinal layer thickness
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
measure: Retinal vessel density
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
measure: Choroidal vascularity index (EDI-OCT)
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
measure: Retinal vessel diameter
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
measure: Optic nerve head blood flow
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
measure: Retinal oxygen extraction
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
measure: Ocular perfusion pressure and arterial blood pressure
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
measure: Retinal oxygen saturation
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
measure: Choroidal thickness (EDI-OCT)
timeFrame: Before the start of the therapy and 6 months after the start of the therapy
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.