Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Head-to-head trial aims to find best way to save sight in IIH patients

NCT ID NCT07440277

Disease control Sponsor: University of Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two common procedures—CSF shunting and dural venous sinus stenting—to see which better preserves vision in adults with idiopathic intracranial hypertension (IIH) who are at risk of permanent sight loss. About 80 participants will be randomly assigned to one of the two procedures and followed for two years. The goal is to determine which treatment is more effective and cost-effective for saving vision.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 63 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Exclusion Criteria: 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 pressure. (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. 21. Presence of intracranial vascular malformation considered clinically symptomatic (current or within 24 months). 22. Anatomical anomaly of the venous sinus which would prevent safe catheterisation and stenting (e.g. multi-channel sinus).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Iih - idiopathic intracranial hypertension are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Constriction, Pathologic optic papillitis pseudotumor cerebri vision disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Iih - idiopathic intracranial hypertension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, United Kingdom

  • Bristol Eye Hospital

    NOT_YET_RECRUITING

    Bristol, United Kingdom

  • King's College Hospital

    RECRUITING

    London, United Kingdom

  • Leeds General Infirmary

    RECRUITING

    Leeds, United Kingdom

  • National Hospital for Neurology and Neurosurgery

    RECRUITING

    London, United Kingdom

  • Princess Alexandra Eye Pavillion

    RECRUITING

    Edinburgh, United Kingdom

  • Queen Elizabeth University Hospital

    RECRUITING

    Glasgow, United Kingdom

  • Queen's Medical Centre

    RECRUITING

    Nottingham, United Kingdom

  • Royal Hull Infirmary

    RECRUITING

    Hull, United Kingdom

  • Royal Victoria Infirmary

    RECRUITING

    Newcastle, United Kingdom

  • Southampton General Hospital

    RECRUITING

    Southampton, United Kingdom

  • Southmead Hospital

    NOT_YET_RECRUITING

    Bristol, United Kingdom

  • Sunderland Eye Infirmary

    RECRUITING

    Sunderland, United Kingdom

  • The Queen Elizabeth Hospital

    RECRUITING

    Birmingham, United Kingdom

  • University Hospital of Wales

    RECRUITING

    Cardiff, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.