IIH Intervention: A clinical trial comparing two treatments (shunts and stents) to preserve vision for people with idiopathic intracranial hypertensio

Not Applicable

• Conditions: Idiopathic intracranial hypertension; Nervous System Diseases

• Registration Number: ISRCTN57142415
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-02
• Last Update Posted: 6 May 2024
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 138

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

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 observational studies will not prevent enrolment in 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. Other secondary causes of raised intracranial pressure, including: haematological (e.g. moderate to severe anaemia); causes of venous obstruction (e.g. cerebral venous sinus thrombosis); medications (e.g. quinolones); systemic disorders (e.g. chronic kidney disease); endocrine (e.g. Addison’s disease); and syndromic (See Protocol Appendix 3 for a full list)
12. Absolute or serious contraindication for general anaesthesia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.