Study aims to prevent blindness in patients with neurological condition

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A new clinical trial being led by the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust aims to identify the best surgical treatment option to prevent blindness in patients with a neurological condition.

Funded by almost £1.5 million from the National Institute for Health Research (NIHR), it is hoped the research will lead to changes in healthcare policy for the treatment of patients with Idiopathic intracranial hypertension (IIH).

Thus far, there is no known cause for the neurological condition, which increases intracranial pressure around the brain without the presence of tumour or disease. Common symptoms of IIH, which is strongly associated with weight, include headaches, visual loss, pulsatile tinnitus, and back and neck pain. If left untreated, the disorder can lead to blindness.

The condition is managed with weight loss and medication, however, in severe cases that present as an emergency with decreasing vision, surgery is needed to prevent blindness.

Currently two different types of surgeries - dural venous sinus stenting (stenting) and cerebrospinal fluid (CSF) shunting - are used to prevent blindness, however there have been no clinical trials to determine which is the best operation. The team will carry out a clinical trial involving up to 138 IIH patients with rapid vision deterioration to establish which of the surgical procedures is the best at saving vision; the safest with least complications; and the most cost effective.

The research, which has been developed in consultation with patient charity IIH UK, will be carried out by a team of experts the University of Birmingham, UHB, and at sites around the UK.

Alex Sinclair, Professor of Neurology at the University of Birmingham, Honorary Consultant Neurologist at UHB and Chief Investigator of the new research project, explained: “CFS shunting involves implanting a thin tube known as a shunt in the brain, which allows the excess cerebrospinal fluid flow to another part of the body, thus rapidly reducing brain pressure.

“However, within the first year of surgery many tubes become blocked or infected and stop working. This, and other complications, have a significant impact on patients’ lives and have important cost implications for the NHS.

“More recently, stenting has been used, which involves placing a small stent across a narrowing of certain blood vessels in the brain, which can improve blood flow and lower brain pressure.”

Philip White, Professor of Interventional and Diagnostic Neuroradiology at the University of Newcastle and Co-Investigator, added: “So far, studies have not provided high quality evidence to show that this procedure can prevent blindness when vision is rapidly declining. Additionally, we need to confirm procedural durability compared with the surgery, which may need to be repeated and establish its safety is at least comparable.”

Miss Susan Mollan, Director of Ophthalmic Research at UHB and Co-Investigator, added: “We hope that the results of our study will provide evidence that will influence NHS policy and will lead to improved care for IIH patients, ensuring they receive the best possible treatment to prevent them from losing their eye sight.”

Amanda Denton, IIH UK Trustee and Research Representative, said: “IIH UK is delighted that this important trial is being carried out. Identifying the best types of intervention is one of our members’ top ten research priorities. Many of our members have shunts and stents to prevent them losing their sight and research to find the most effective method with the least complications is vital to improve their quality of life.”

The trial, will see participants being allocated to CSF shunting or stenting, which will be decided at random by a computer. The main outcome of the trial to be evaluated will be preservation of vision. A number of key additional outcomes, including treatment-related complications, headache and patient reported quality of life, will also be assessed.

Dr Ben Wakerley, Consultant Neurologist at UHB and Co-Investigator, comments: “The impact of these interventions on headache and quality of life have been highlighted to be of key importance by patients.”

An economic evaluation will be performed, led by Professor Emma Frew, University of Birmingham Co-Investigator, to estimate the cost-effectiveness of shunting versus stenting. Participants will be asked to attend routine hospital check-up visits over a year. Their health would then be monitored through linked NHS database records for longer-term follow up at two years.

Notes to Editors

  • For more information, please contact Emma McKinney, Communications Manager, University of Birmingham, on +44 7815607157. Alternatively, contact the Press Office out of hours on +44 (0)7789 921165.
  • A network of co-investigators around the UK will contribute to the trial as part of the UK IIH research network including: Dr Madigan, St George's University Hospitals NHS Foundation Trust, Dr Denize Atan, Bristol Eye Hospital, Ms Jayne Best, Royal Victoria Hospital Belfast, Mr Patrick Yu Wai Man, Addenbrooke’s Hospital, Mr Eoin O’Sullivan, Kings College Hospital NHS Foundation Trust, Mr Tom Hughes, University Hospital of Wales, Mr Mansoor Foroughi, Brighton and Sussex University Hospital NHS Trust, Honorary Professor Fayyaz Ahmed, Hull and East Yorkshire Hospitals NHS Trust, Dr Pushkar Shah, NHS Greater Glasgow & Clyde, Mr Ryan Matthew, Leeds Hospital NHS Trust, Ms Gemma Maxwell, Newcastle Upon Tyne Hospital NHS Foundation Trust, Ms Shery Thomas, Nottingham University Hospitals NHS Trust, Mrs Sui Wong, Moorfield Eye Hospital NHS Foundation Trust, Mr Mandagere Vishwanath, Central Manchester University Hospitals NHS Foundation Trust, and Mr Fion Bremmer, alongside support at University of Birmingham from Simon Bach, Mr Colin Watts and Dr Kristian Brock.
  • The University of Birmingham is ranked amongst the world’s top 100 institutions, and its work brings people from across the world to Birmingham, including researchers and teachers and more than 6,500 international students from nearly 150 countries.
  • University Hospitals Birmingham NHS Foundation Trust runs the Queen Elizabeth Hospital Birmingham, Birmingham Chest Clinic, Heartlands Hospital, Good Hope Hospital, Solihull Hospital and various community services across the region. The Trust has regional centres for trauma, burns, plastics, neurosciences, dermatology and cancer. It also has centres of excellence for vascular, bariatric and pathology services, as well as the treatment of MRSA and other infectious diseases. The Trust hosts the Institute of Translational Medicine (ITM) and led the West Midlands Genomics Medicine Centre as part of the national 100,000 Genomes Project. UHB is also proud to host the Royal Centre for Defence Medicine (RCDM) at the Queen Elizabeth Hospital Birmingham. The RCDM provides dedicated training for defence personnel and is a focus for medical research.
  • The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR:
    • Funds, supports and delivers high quality research that benefits the NHS, public health and social care
    • Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
    • Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
    • Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
    • Partners with other public funders, charities and industry to maximise the value of research to patients and the economy
    • The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK government.