Idiopathic Intracranial HypertensionNCT06545981
Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension
An observational study of Idiopathic Intracranial Hypertension, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Intracranial Hypertension
- What is being tested?
- Lumbar puncture and administration of medication
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 28 May 2024to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Gerhard Garhöfer, +43 40400 29880, gerhard.garhoefer@meduniwien.ac.at
About this study
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.
Read the 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.
- Conditions
- Idiopathic Intracranial Hypertension
- Being tested
- Lumbar puncture and administration of medication
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar puncture and administration of medicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic intracranial hypertension (Group 1) | 24 subjects with idiopathic intracranial hypertension Receives: Other: Lumbar puncture and administration of medication | |
| Healthy control subjects (Group 2) | 24 age- and sex-matched control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before the start of the therapy and 6 months after the start of the therapy
Secondary outcomes (11)
Neurovascular coupling
Change in neurovascular coupling in patients with idiopathic intracranial hypertension before and 6 months after therapy (Dynamic Vessel Analyzer, IMEDOS, Jena, Germany)
Measured: Before the start of the therapy and 6 months after the start of the therapy
Retinal nerve fiber layer thickness
Change in retinal nerve fiber layer thickness in patients with idiopathic intracranial hypertension before and 6 months after therapy.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Before the start of the therapy and 6 months after the start of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start28 May 2024
- Primary completion28 May 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545981
- Sponsor's protocol ID
- OPHT-241123
- Status last verified
- Aug 2024
- First submitted
- 12 Jun 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26700907Pruckner 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.
PubMed 37650963Wang 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.
PubMed 34929642Sugiyama 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.
PubMed 19725814Tamaki 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.
PubMed 9147189Miller 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.
PubMed 19168816
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension
- ClinicalTrials.gov ID
- NCT06545981
- Acronym / sponsor ID
- OPHT-241123
- Conditions
- Idiopathic Intracranial Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 28 May 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic intracranial hypertension (Group 1) | – | Other: Lumbar puncture and administration of medication24 subjects with idiopathic intracranial hypertension |
| Healthy control subjects (Group 2) | – | –24 age- and sex-matched control subjects |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar puncture and administration of medicationPatients 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. | Other | Idiopathic intracranial hypertension (Group 1) |
Primary outcome
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).
11 secondary outcomes
Neurovascular coupling
Time frame: Before the start of the therapy and 6 months after the start of the therapy
Retinal nerve fiber layer thickness
Time frame: Before the start of the therapy and 6 months after the start of the therapy
Retinal and retinal layer thickness
Time frame: Before the start of the therapy and 6 months after the start of the therapy
Retinal vessel density
Time frame: Before the start of the therapy and 6 months after the start of the therapy
Choroidal vascularity index (EDI-OCT)
Time frame: Before the start of the therapy and 6 months after the start of the therapy
Retinal vessel diameter
Time frame: Before the start of the therapy and 6 months after the start of the therapy
Optic nerve head blood flow
Time frame: Before the start of the therapy and 6 months after the start of the therapy
Retinal oxygen extraction
Time frame: Before the start of the therapy and 6 months after the start of the therapy
Ocular perfusion pressure and arterial blood pressure
Time frame: Before the start of the therapy and 6 months after the start of the therapy
Retinal oxygen saturation
Time frame: Before the start of the therapy and 6 months after the start of the therapy
Choroidal thickness (EDI-OCT)
Time frame: Before the start of the therapy and 6 months after the start of the therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Background: PubMed 26700907Markey 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.
- Background: PubMed 37650963Pruckner 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.
- Background: PubMed 34929642Wang 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.
- Background: PubMed 19725814Sugiyama 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.
- Background: PubMed 9147189Tamaki 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.
- Background: PubMed 19168816Miller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Intracranial Hypertension, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhöfer (+43 1 40400 29880, gerhard.garhoefer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve head blood flow (time frame: Before the start of the therapy and 6 months after the start of the therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545981, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.