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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idiopathic intracranial hypertension (Group 1) | 24 subjects with idiopathic intracranial hypertension |
| |
| Healthy control subjects (Group 2) | 24 age- and sex-matched control subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Optic nerve head blood flow | Change in optic nerve head blood flow in patients with idiopathic intracranial hypertension before and 6 months after therapy (LSFG). | Before the start of the therapy and 6 months after the start of the therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Neurovascular coupling | Change in neurovascular coupling in patients with idiopathic intracranial hypertension before and 6 months after therapy (Dynamic Vessel Analyzer, IMEDOS, Jena, Germany) | Before the start of the therapy and 6 months after the start of the therapy |
| Retinal nerve fiber layer thickness |
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Inclusion criteria for patients with idiopathic intracranial hypertension
Inclusion criteria for healthy age- and sex-matched control subjects
Exclusion criteria for patients with idiopathic intracranial hypertension and healthy age- and sex-matched control subjects:
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A total of 48 patients will be included in the study:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerhard Garhöfer | Contact | +43 1 40400 29880 | gerhard.garhoefer@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26700907 | Background | 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. | |
| 37650963 | Background | 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. |
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| ID | Term |
|---|---|
| D011559 | Pseudotumor Cerebri |
| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
Change in retinal nerve fiber layer thickness in patients with idiopathic intracranial hypertension before and 6 months after therapy. |
| Before the start of the therapy and 6 months after the start of the therapy |
| Retinal and retinal layer thickness | Change in retinal and retinal layer thickness in patients with idiopathic intracranial hypertension before and 6 months after therapy (OCT). | Before the start of the therapy and 6 months after the start of the therapy |
| Retinal vessel density | Change in retinal vessel density in patients with idiopathic intracranial hypertension before and 6 months after therapy (OCT-A). | Before the start of the therapy and 6 months after the start of the therapy |
| Choroidal vascularity index (EDI-OCT) | 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). | Before the start of the therapy and 6 months after the start of the therapy |
| Retinal vessel diameter | Change in retinal vessel diameter (µm) in patients with idiopathic intracranial hypertension before and 6 months after therapy (retinal oximetry). | Before the start of the therapy and 6 months after the start of the therapy |
| Optic nerve head blood flow | Change in optic nerve head blood flow in patients with idiopathic intracranial hypertension before and 6 months after therapy (LDF). | Before the start of the therapy and 6 months after the start of the therapy |
| Retinal oxygen extraction | Change in retinal oxygen extraction in patients with idiopathic intracranial hypertension before and 6 months after therapy (LSFG, retinal oximetry). | Before the start of the therapy and 6 months after the start of the therapy |
| Ocular perfusion pressure and arterial blood pressure | Change in ocular perfusion pressure and arterial blood pressure in patients with idiopathic intracranial hypertension before and 6 months after therapy. | Before the start of the therapy and 6 months after the start of the therapy |
| Retinal oxygen saturation | Retinal oxygen saturation (SO2) in patients with idiopathic intracranial hypertension before and 6 months after therapy (retinal oximetry). | Before the start of the therapy and 6 months after the start of the therapy |
| Choroidal thickness (EDI-OCT) | Change in choroidal thickness (µm) in patients with idiopathic intracranial hypertension before and 6 months after therapy (EDI-OCT). | Before the start of the therapy and 6 months after the start of the therapy |
| 34929642 | Background | 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. |
| 19725814 | Background | 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. |
| 9147189 | Background | 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. |
| 19168816 | Background | 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. |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |