Intervention to preserve vision in idiopathic intracranial hypertension: evaluation of clinical effectiveness and cost-effectiveness
Idiopathic intracranial hypertension
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 researchers aim to disprove, is that dural venous sinus stenting (DVSS) is equivalent to cerebrospinal fluid (CSF) shunting in terms of the long-term trajectory of reducing papilloedema preventing visual loss during the treatment of idiopathic intracranial hypertension (IIH). CSF shunting represents the standard of care treatment for these patients and so makes the natural comparator. The secondary and exploratory outcomes will help the researchers to ascertain how these treatments affect different parts of the lives of patients with IIH. The researchers have chosen a randomized design (randomized 1:1) to provide an unbiased comparison and to avoid the potential confounding factors implicit in non-randomised comparisons. Once a potential participant has completed the screening process and is deemed eligible for study inclusion, they will be randomized on a 1:1 basis using computer-generated randomization via the Trial eRDC system. Patient treatment allocation will be stratified by the following criteria: 1. Presence of or intention to insert CSF lumbar drain prior to the protocol-defined intervention 2. Duration of IIH diagnosis (diagnosis ≤28 days from randomisation or diagnosis >28 days from randomisation) 3. The degree of papilloedema defined by the Frisén grade being <4 or ≥4 in the most affected study eye To avoid any possibility of the treatment allocation becoming too predictable, a random factor will be included within the algorithm whereby for a proportion of the allocations true randomisation will be implemented rather than by using the minimisation allocation. 80% of randomisations will be ascertained using the minimisation allocation, with the remaining 20% being true randomisation. In this manner the local responsible clinician will not be able to predict or i
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
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, artificia