IIH Intervention
Research type
Research Study
Full title
Intervention To Preserve Vision In Idiopathic Intracranial Hypertension: Evaluation Of Clinical Effectiveness And Cost Effectiveness
IRAS ID
314408
Contact name
Alexandra Sinclair
Contact email
Sponsor organisation
University of Birmingham
ISRCTN Number
ISRCTN57142415
Clinicaltrials.gov Identifier
XX2014, CRCTU
Duration of Study in the UK
12 years, 6 months, days
Research summary
Idiopathic intracranial hypertension (IIH) is a neurological condition characterised by increased pressure inside the skull, called intracranial pressure (ICP). It is more common in women of reproductive age with obesity.
Common symptoms of IIH include headaches, blurred vision and ringing in the ears. If left untreated, the disorder may cause blindness. The majority of patients with IIH are managed with weight loss and medications. Fewer than 10% of patients develop progressive visual loss and require urgent intervention to reduce ICP and preserve vision. This trial will compare the two most common interventions performed in the UK and evaluate their clinical and cost effectiveness. The first is called Cerebrospinal fluid (CSF) shunting and involves a procedure where a thin tube called a shunt is implanted in the body to drain brain fluid. The second is called dural venous sinus stenting (DVSS) and involves a procedure where a metallic mesh tube called stent is implanted inside a brain blood vessel. Both procedures can preserve vision, but there is no strong evidence to support one over the other.
We will invite 138 adults with IIH and at risk of permanent visual loss to take part. Participants will have the same chance to be treated with CSF shunting or DVSS. The trial will be conducted in NHS hospitals located in England, Wales and Scotland.
Following trial intervention, the participants will be followed up through regular visits for 24 months. Participants will be closely monitored for any side effects and potential device failure, and for changes in vision, headaches and quality of life. We will also collect information related to IIH treatment through NHS Digital over 10 years. At the end of the trial, we will know which intervention is the most effective to save the vision and the most cost-effective.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
22/WM/0230
Date of REC Opinion
12 Dec 2022
REC opinion
Further Information Favourable Opinion