Understanding idiopathic intracranial hypertension: mechanisms, management, and future directions.
Keira A Markey, Susan P Mollan, Rigmor H Jensen...
https://pubmed.ncbi.nlm.nih.gov/26700907Actively Recruiting
Age: 18Years - 90Years
All Genders
Healthy Volunteers
ID06545981
Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension
Led by Medical University of Vienna · Updated on 2024-08-30
48
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying blood flow in the optic nerve head and microcirculation in people with idiopathic intracranial hypertension (IIH), a condition with increased pressure inside the skull that can cause severe vision loss if untreated. The study compares blood flow in IIH patients before and after therapy with healthy volunteers matched by age and sex. Additional measurements include retinal blood flow, oxygen levels, and neurovascular responses in the eye. Participants include 24 individuals with IIH and 24 healthy controls. IIH patients will have lumbar punctures and receive medication to lower intracranial pressure, though these treatments are not part of the study procedures. Blood flow in the eye and various retinal and choroidal parameters will be measured before starting therapy and again six months later. During the study, participants will undergo non-invasive eye imaging and measurements such as retinal thickness, vessel density, retinal oxygen saturation, and ocular perfusion pressure. The main outcome is optic nerve head blood flow assessed before treatment and six months afterward. Researchers will also monitor other eye health factors to understand changes over time in IIH and healthy subjects. The study runs until August 2026.
CONDITIONS
Brief Title
Ocular Perfusion in Patients With Idiopathic Intracranial Hypertension
Who Can Participate
Age: 18Years - 90Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- Signed informed consent
- Newly diagnosed idiopathic intracranial hypertension or relapse of the condition
- Non-smokers
- Normal ophthalmic findings for healthy control subjects
- Normal medical history for healthy control subjects
- Healthy control subjects must be age- and sex-matched
You will not qualify if you...
- Blood donation within three weeks before the study
- Symptoms of illness within three weeks before 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 presence of cerebral vascular diseases such as arteriovenous malformation, aneurysm, or major artery stenosis
- History or presence of intracranial infections like meningitis
- History or presence of other neurological diseases including brain tumor, hydrocephalus, or degenerative diseases
- Receiving corticosteroids or immunosuppressant therapy
- Pregnancy or breastfeeding
- Women of childbearing potential not using effective contraception unless menopausal, hysterectomized, or sterilized
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Before the start of therapy
Participants undergo measurements to assess optic nerve head blood flow, retinal blood flow, retinal oxygen saturation, retinal neurovascular coupling, and other ocular parameters before therapy begins.
1 visit (in-person)
Long-term Monitoring
Duration - 6 months after the start of therapy
Participants are re-evaluated 6 months after the start of therapy to measure changes in optic nerve head blood flow and other ocular parameters to monitor disease progression or improvement.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
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Research Team
G
Gerhard Garhöfer
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
The Vienna idiopathic intracranial hypertension database-An Austrian registry.
Philip Pruckner, Christoph Mitsch, Stefan Macher...
https://pubmed.ncbi.nlm.nih.gov/37650963Idiopathic intracranial hypertension: Pathophysiology, diagnosis and management.
Michael T M Wang, M Tariq Bhatti, Helen V Danesh-Meyer
https://pubmed.ncbi.nlm.nih.gov/34929642Use of laser speckle flowgraphy in ocular blood flow research.
Tetsuya Sugiyama, Makoto Araie, Charles E Riva...
https://pubmed.ncbi.nlm.nih.gov/19725814Real-time measurement of human optic nerve head and choroid circulation, using the laser speckle phenomenon.
Y Tamaki, M Araie, K Tomita...
https://pubmed.ncbi.nlm.nih.gov/9147189Blood flow velocities are reduced in the optic nerve of children with elevated intracranial pressure.
Marijean M Miller, Taeun Chang, Robert Keating...
https://pubmed.ncbi.nlm.nih.gov/19168816