Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension

NCT06545981 | Recruiting

• 1 other identifier: OPHT-241123
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Intracranial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Neurovascular coupling

  Before the start of the therapy and 6 months after the start of the therapy

• Retinal nerve fiber layer thickness

  Before the start of the therapy and 6 months after the start of the therapy

• Retinal and retinal layer thickness

  Before the start of the therapy and 6 months after the start of the therapy

• Retinal vessel density

  Before the start of the therapy and 6 months after the start of the therapy

• Choroidal vascularity index (EDI-OCT)

  Before the start of the therapy and 6 months after the start of the therapy

Study Arms (2)

Idiopathic intracranial hypertension (Group 1)

24 subjects with idiopathic intracranial hypertension

Other: Lumbar puncture and administration of medication

Healthy control subjects (Group 2)

24 age- and sex-matched control subjects

Interventions

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.

Idiopathic intracranial hypertension (Group 1)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Men and Women aged ≥ 18 years
• Signed informed consent
• Newly diagnosed idiopathic intracranial hypertension or relapse of idiopathic intracranial hypertension
• Non-Smokers
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (6)

• 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 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.

  PMID: 37650963 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.

  PMID: 34929642 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.

  PMID: 19725814 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.

  PMID: 9147189 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.

  PMID: 19168816 BACKGROUND

MeSH Terms

Conditions

Pseudotumor Cerebri

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Gerhard Garhöfer

CONTACT

+43 1 40400 29880; gerhard.garhoefer@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. Doz. Dr. med. univ.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: August 9, 2024
• Study Start: May 28, 2024
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

AU (1)