Idiopathic intracranial hypertension Nervous System Diseases
Conditions
Interventions
Current interventions as of 31/03/2026:
Participants are randomized to undergo either cerebrospinal fluid (CSF) shunting or dural venous sinus stenting (DVSS).
The null hypothesis, which the resear
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 31/03/2026: 1. Diagnosis of IIH by the IIH consensus guidelines with papilloedema and at risk of visual loss 2. Presence of papilloedema (Frisén grade = 3) in at least one eye 3. Age 18 to < 64 years at the time of consent 4. Patients must be suitable for and willing to proceed with both CSF shunting (VP or Lumboperitoneal shunts only) and DVSS. 5. Able to provide written informed consent _____ Previous key inclusion criteria: List of principal criteria: 1. Diagnosis of idiopathic intracranial hypertension (IIH) by the IIH consensus guideline with bilateral papilloedema and a risk of permanent visual loss 2. Visual loss in at least one eye (study eye), secondary to papilloedema that cannot be explained by other ocular or central nervous system (CNS) pathology 3. Participants will be suitable for both cerebrospinal fluid (CSF) shunting and dural venous sinus stenting (DVSS) 4. Age 18 to <64 years at the time of consent 5. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 31/03/2026: 1. Presence of current venous sinus thrombosis on diagnostic brain imaging by either MRI, MRV or CTV 2. Previous surgery for IIH including, optic nerve sheath fenestration, CSF shunting procedures, sub-temporal decompression and DVSS. 3. Previous bariatric surgery within the last 3 months 4. Patients with a past ophthalmic history, except refraction error, affecting the eligible eyes (study eyes) that could affect the vision. 5. Patient is, at the time of signing the informed consent, a user of recreational or illicit drugs (including marijuana) or has had a recent history (within the last year) of drug or alcohol abuse or dependence, in the opinion of the investigator. 6. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study. 7. Have participated in any other interventional study within 30 days prior to the screening visit (of note participation in the IIH Life database or other observational studies will not prevent enrolment to this study). 8. Previous randomisation for treatment in the present study. 9. Pregnant. 10. Absolute or serious contraindication to standard anti-thrombotic regimen peri and post stenting. 11. Secondary causes of raised intracranial pressure1. (Refer to protocol appendix 3 for additional information.) 12. History of significant documented iodine-based contrast allergy. 13. History of documented allergy to nitinol or nickel. 14. Absolute or serious contraindication for general anaesthesia. 15. Previous diagnosis of a hypercoagulable state (Factor V Leiden, Protein C or S deficiency, Anticardiolipin antibodies, Lupus anticoagulant, B2-glycoprotein-1 antibodies, or Hyperhomocysteinaemia). 16. Currently requiring full anticoagulation for other medical reasons, such as atrial fibrillation, artificial valves, deep vein thrombosis or pulmonary embolism. 17. Documented prior non-traumatic intracranial haemorrhage. 18. History of deep vein thrombosis or pulmonary embolism (within the last 24 months). 19. History of severe carotid atherosclerotic disease. 20. History of heart failure, dilated cardiomyopathy or congenital heart disease, etc. that are assessed as at high thrombotic risk. _____ Previous key exclusion criteria: List of principal criteria: 1. Presence of current venous sinus thrombosis on diagnostic brain imaging by either Magnetic Resonance Imaging (MRI), Magnetic Resonance Venography (MRV) or Computed Tomography Venography (CTV) 2. A completely normal CTV (or MRV) with clear visualisation of the whole sinus with no evidence of stenosis(es) 3. Previous surgery for IIH including, optic nerve sheath fenestration, CSF shunting procedures, sub-temporal decompression and DVSS. 4. Previous bariatric surgery within the last 3 months 5. Patients with a past ophthalmic history affecting the eligible eye(s) that could affect the vision (e.g. prior optic atrophy) 6. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study 7. Have participated in any other interventional study within 1 month prior to the screening visit (of note participation in the IIH Life database or other ob
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome(s) as of 31/03/2026: Global thickness of the retinal nerve fibre layer (RNFL) over 6 months, as measured by OCT (analysed using repeated measures methods) using data collected at baseline, and then 1 week, 2 weeks, 1, 2, 3, 4, and 6 months post-intervention, and at any unscheduled visit for revision/device failure between Visit 2 and 6 months post-intervention. _____ Previous primary outcome(s): Perimetric mean deviation (PMD) is measured using a Humphrey Visual Field (HVF) over 12 months (analysed using repeated measures methods) using data collected at baseline, and then 1 week, 2 weeks, 1, 2, 3, 4, 6 and 12 months post-intervention, and at any unscheduled visit for revision/device failure between Visit 2 and 12 months post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 31/03/2026: Secondary outcome measures have been listed by category for clarity. Analysis will be over the time period stated (analysed using repeated measures methods). The primary efficacy analysis will use an interval of baseline to 6 months (analysis occurring once the final patient has completed their 6-month assessment) with longer-term follow-up using an interval of baseline to 12 months (occurring once the final patient has completed their 12-month assessment). and baseline to 24 months (occurring once the final patient has completed their 24-month assessment). Vision: 1. Global thickness of the retinal nerve fibre layer (RNFL) over 12 and 24 months (analysed using repeated measures methods) using data collected at 12 and 24 months post-intervention, and at any unscheduled visit for revision/device failure. 2. Total retinal thickness measured using Optical Coherence Tomography (OCT) over 6, 12 and 24 months (analysed using repeated measures methods) using data collected at baseline, and then 1 week, 2 weeks, 1, 2, 3, 4, 6, 12 and 24 months post-intervention (the latter only pertinent to the 24-month analyses), and at any unscheduled visit for revision/device failure. 3. Disc global volume measured using Optical Coherence Tomography (OCT) over 6, 12 and 24 months (analysed using repeated measures methods) using data collected at baseline, and then 1 week, 2 weeks, 1, 2, 3, 4, 6, 12 and 24 months post-intervention (the latter only pertinent to the 24-month analyses), and at any unscheduled visit for revision/device failure. 4. Disc central thickness measured using Optical Coherence Tomography (OCT) over 6, 12 and 24 months (analysed using repeated measures methods) using data collected at baseline, and then 1 week, 2 weeks, 1, 2, 3, 4, 6, 12 and 24 months post-intervention (the latter only pertinent to the 24-month analyses), and at any unscheduled visit for revision/device failure. 5. Disc maximum height measured usin | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public Contact- IIH Intervention Trial Office
Outcome results
None listed