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Cerebrospinal fluid shunting or dural venous sinus stenting to preserve vision in idiopathic intracranial hypertension (IIH Intervention)

Idiopathic intracranial hypertension (IIH) is a condition where fluid pressure builds up around the brain. While most people manage it with lifestyle changes or tablets, some face a sudden risk of losing their sight and need surgery. Doctors currently use two main operations to lower this pressure: placing a thin tube (a shunt) to drain extra brain fluid, or placing a small wire mesh tube (a stent) inside a brain blood vessel to improve blood flow. Both treatments are used across the NHS, but doctors do not yet know which one works best. This study randomly places participants into one of the two treatment groups. Over two years, specialists will closely check your vision, headaches, and general well-being across 11 hospital visits and one phone call to see which procedure provides the best long-term results.

At a glance

Status
Recruiting
Sponsor
University of Birmingham
Enrolment target
80
Start
22 Nov 2023
Estimated completion
28 Feb 2027

What is this study about?

Idiopathic intracranial hypertension (IIH) happens when fluid builds up naturally inside the skull, putting extra pressure on the brain and the optic nerves that connect your eyes to your brain. Common symptoms include severe headaches, pulsing noises in the ears, and blurred or double vision. For most people, weight loss and medications manage the condition well. However, for a small number of people, the pressure builds up rapidly and puts their eyesight in serious danger. When this happens, an urgent operation is needed to protect their vision.

At present, UK surgeons usually choose between two different operations. One option is called cerebrospinal fluid (CSF) shunting, where a thin, flexible tube is placed under the skin to safely drain excess brain fluid away to another part of the body. The other option is dural venous sinus stenting, where a specialist guides a tiny wire mesh tube into a narrowed blood vessel in the brain to keep it open. While both operations are already used in NHS hospitals, there is not yet enough clear evidence showing which one protects eyesight better or has fewer complications.

The IIH Intervention study aims to solve this puzzle. By directly comparing the two procedures across NHS hospitals in England, Scotland, and Wales, researchers want to find out which option is safer, more effective at saving sight, and better value for healthcare services. The findings will help future patients receive the most reliable treatment without delay.

Key takeaways

  • Compares two standard NHS operations (shunt vs stent) to protect vision in people with severe IIH.
  • Open to adults aged 18 to 63 who face an urgent risk of permanent sight loss.
  • Participants are randomly assigned to one of the two surgical options.
  • Follow-up lasts for two years and includes 11 hospital visits and one phone call.
  • Aims to show which procedure is safer, more effective, and better value for the NHS.

Who may be eligible?

This study is designed for adults aged 18 to 63 who have been diagnosed with IIH and have significant optic nerve swelling that puts them at risk of permanent sight loss. To take part, your medical team must agree that both surgical options—a shunt or a stent—are medically safe and suitable for you, and you must be willing to receive either procedure.

You cannot take part if you have already had surgery or a shunt for IIH in the past, or if you have had weight loss surgery within the last three months. People with a history of blood clots in the brain veins, other eye conditions that affect vision, or recent problems with drug or alcohol misuse are also unable to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am aged between 18 and 63.
  2. I have been diagnosed with IIH with optic nerve swelling that threatens my eyesight.
  3. My specialist agrees that both a shunt and a stent are suitable options for me.
  4. I have not had surgery or a shunt for IIH in the past.
  5. I have not had weight loss surgery in the last 3 months.
Answer every question to see your result.

What does participation involve?

If you decide to take part, a computer programme will randomly choose whether you receive a shunt or a stent. You have an equal chance of receiving either treatment. Both procedures are routine NHS operations performed by experienced specialists. After your surgery, you will be followed up closely for two years. This involves attending 11 hospital clinic appointments and having one telephone check-up. During these visits, doctors will test your eyesight, check for any headaches or complications, and ask how you are feeling. The study team will also review your routine NHS health records to follow your long-term progress.

Potential risks and benefits

Taking part does not guarantee direct medical benefits beyond the standard care you would normally receive, but you will benefit from very close monitoring by eye and brain specialists. Your involvement will also help doctors understand how to give future patients the best care. Because both operations are already standard NHS treatments, taking part does not add any unusual experimental risks. However, as with any surgery on the brain or blood vessels, there are risks such as infection, blockage, or the need for repeat surgery. Your team will discuss these with you in detail. You are entirely free to leave the study at any time without your regular NHS care being affected.

Locations (16)

  • Queen Elizabeth Hospital
    Approximate
    Birmingham, England
  • Kings College Hospital
    Approximate
    London, England
  • Addenbrookes
    Approximate
    Cambridge, England
  • Queen Elizabeth University Hospital
    Approximate
    Glasgow, Scotland
  • Leeds General Infirmary
    Approximate
    Leeds, England
  • The Royal Victoria Infirmary
    Unverified
    Newcastle upon Tyne, England
  • National Hospital for Neurology & Neurosurgery
    Unverified
    London, England
  • Queens Medical Centre
    Unverified
    Nottingham, England
  • Southampton General Hospital
    Unverified
    Southampton, England
  • Kings College Hospital
    Unverified
    London, England
  • University Hospital of Wales
    Unverified
    Cardiff, Wales
  • Hull Royal Infirmary
    Unverified
    Hull, England

Common questions

Are these treatments experimental?

No. Both shunts and stents are established, approved operations already performed regularly in NHS hospitals to protect eyesight in people with IIH.

Can I choose which operation I have?

No. A computer randomly assigns the treatment. This is done to ensure the comparison between the two procedures is completely fair and accurate.

How long will I be involved in the study?

The study team will monitor your recovery, eye health, and well-being for two years following your operation.

Will taking part cost me anything?

No. All treatments and trial-related hospital checks are provided through the NHS at no cost to you.

What happens if I change my mind?

You can withdraw from the study at any point. Your standard NHS treatment and your relationship with your doctors will continue as normal.

How to find out more

- IIH Intervention Trial Office

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Cerebrospinal fluid shunting or dural venous sinus stenting …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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