IIH - Idiopathic Intracranial HypertensionInterventionNCT07440277
IIH Intervention: A Clinical Trial Comparing 2 Treatments (Shunts and Stents) Evaluation Of Clinical Effectiveness And Cost Effectiveness
A study testing CSF shunt and DVSS in people with IIH - Idiopathic Intracranial Hypertension, run by University of Birmingham at 15 sites in United Kingdom.
Trial summary
Background and study aims 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. Read more about this study
- Who is it for?
- Ages 18 to 63 years
- Conditions the study is for
- IIH - Idiopathic Intracranial Hypertension
- What is being tested?
- CSF shunt and DVSS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- 18 Jul 2023to 28 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 63 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of IIH by the IIH consensus guidelines with papilloedema and at risk of visual loss.
- Presence of papilloedema (Frisén grade ≥ 3) in at least one eye
- Age 18 to < 64 years at the time of consent.
- Patients must be suitable for and willing to proceed with both CSF shunting (VP or Lumboperitoneal shunts only) and DVSS.
- Able to provide written informed consent.
Who cannot join
- Presence of current venous sinus thrombosis on diagnostic brain imaging by either MRI, MRV or CTV
- Previous surgery for IIH including, optic nerve sheath fenestration, CSF shunting procedures, sub-temporal decompression and DVSS.
- Previous bariatric surgery within the last 3 months
- Patients with a past ophthalmic history, except refraction error, affecting the eligible eyes (study eyes) that could affect the vision.
- 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.
- 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.
Show all 22Show fewer
- 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).
- Previous randomisation for treatment in the present study.
- Pregnant.
- Absolute or serious contraindication to standard anti-thrombotic regimen peri and post stenting.
- Secondary causes of raised intracranial pressure. (Refer to Protocol appendix 3 for additional information.)
- History of significant documented iodine-based contrast allergy.
- History of documented allergy to nitinol or nickel.
- Absolute or serious contraindication for general anaesthesia.
- Previous diagnosis of a hypercoagulable state (Factor V Leiden, Protein C or S deficiency, Anticardiolipin antibodies, Lupus anticoagulant, B2-glycoprotein-1 antibodies, or Hyperhomocysteinaemia).
- Currently requiring full anticoagulation for other medical reasons, such as atrial fibrillation, artificial valves, deep vein thrombosis or pulmonary embolism.
- Documented prior non-traumatic intracranial haemorrhage.
- History of deep vein thrombosis or pulmonary embolism (within the last 24 months).
- History of severe carotid atherosclerotic disease.
- History of heart failure, dilated cardiomyopathy or congenital heart disease, etc. that are assessed as at high thrombotic risk.
- Presence of intracranial vascular malformation considered clinically symptomatic (current or within 24 months).
- Anatomical anomaly of the venous sinus which would prevent safe catheterisation and stenting (e.g. multi-channel sinus).
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United Kingdom15 sites, 15 recruiting
- Recruiting
The Queen Elizabeth Hospital
Birmingham
Georgios Tsermoulas
- Not yet recruiting
Bristol Eye Hospital
Bristol
Denise Atan
- Not yet recruiting
Southmead Hospital
Bristol
Richard Edwards
- Recruiting
Addenbrooke's Hospital
Cambridge
Alexis Yoannides
- Recruiting
University Hospital of Wales
Cardiff
Tom Hughes
- Recruiting
Princess Alexandra Eye Pavillion
Edinburgh
Jonathan Downer
- Recruiting
Queen Elizabeth University Hospital
Glasgow
Pushkar Shah
- Recruiting
Royal Hull Infirmary
Hull
Fayyaz Ahmed
- Recruiting
Leeds General Infirmary
Leeds
Esteban Taleti
- Recruiting
King's College Hospital
London
James McHugh
- Recruiting
National Hospital for Neurology and Neurosurgery
London
Fion Bremmer
- Recruiting
Royal Victoria Infirmary
Newcastle
Gemma Maxwell
- Recruiting
Queen's Medical Centre
Nottingham
Shery Thomas
- Recruiting
Southampton General Hospital
Southampton
Jason McDonald
- Recruiting
Sunderland Eye Infirmary
Sunderland
Gemma Maxwell
About this study
Official title: Intervention To Preserve Vision In Idiopathic Intracranial Hypertension: Evaluation Of Clinical Effectiveness And Cost Effectiveness (IIH Intervention)
Background and study aims 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 a 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. Participants will have the same chance to be treated with CSF shunting or DVSS. The aim of the trial is to know which intervention is the most effective to save the vision and the most cost-effective.
Who can participate? Adults with a diagnosis of IIH at risk of permanent sight loss
Read more
What does the study involve? The trial will be conducted in NHS hospitals located in England, Wales and Scotland. Participants are randomly allocated to undergo cerebrospinal fluid (CSF) shunting or dural venous sinus stenting (DVSS). Afterwards the participants will be asked to attend 11 hospital appointments and one telephone appointment. This follow-up will take 2 years from start to finish. Participants will be closely monitored for any side effects and potential device failure, and for changes in vision, headaches and quality of life. The researchers will also collect health data from NHS Digital (the national custodian of NHS health and social care data).
What are the possible benefits and risks of participating? There are no direct benefits from taking part in the trial but the information gained from this trial may help improve treatment for adults with IIH in the future. Participants may be seen more often and/or feel more supported as a consequence of their involvement in the trial. As with any intervention, there are risks and complications, but there are no additional disadvantages or risks involved in taking part in this trial. Both CSF shunting and stenting are treatments for IIH (shunting is widely used internationally, and in some hospitals, stenting is used as part of the standard of care). Participants require an intervention to prevent sight loss. None of these treatments is experimental but at present, there is not enough information to determine which treatment is most suitable and provides the higher level of health benefits to the individual.
Where is the study run from? University of Birmingham (UK)
When is the study starting and how long is it expected to run for? The first site opened in July 2023, and the last patient last visit is expected in May 2028
Who is funding the study? National Institute for Health Research (NIHR, grant number: NIHR131211) (UK)
Who is the main contact? IIH Intervention Trial manager, IIHIntervention@trials.bham.ac.uk (UK)
- Being tested
- CSF shunt, DVSS
- Keywords
- DVSS, dural venous sinus stent, stent, shunt, intracranial pressure, stenosis, papilloedema, visual loss, OCT, RNFL
- Medical subject headings
- Pseudotumor Cerebri, Constriction, Pathologic, Papilledema, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF shuntDevice
CSF shunt may be ventriculoperitoneal (VP) or lumboperitoneal (LP) at the discretion of the treating medical team.
DVSSDevice
Dural Venous Sinus Stent. Exact make and model of device not mandated by protocol.
| Study group | Role | What they receive |
|---|---|---|
| CSF shunting | Active comparator | Cerebrospinal fluid shunt Receives: Device: CSF shunt |
| DVSS | Experimental | Dural Venous Sinus Stenting Receives: Device: DVSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global thickness of the retinal nerve fibre layer (RNFL) over 6 months, as measured by OCT
Global thickness of the retinal nerve fibre layer (RNFL) over 6 months, as measured in micrometers by OCT
Measured: 6 months
Secondary outcomes (32)
Global thickness of the retinal nerve fibre layer (RNFL)
Global thickness of the retinal nerve fibre layer (RNFL) measured in micrometers by OCT over 12 and 24 months
Measured: 12 months, 24 months
Total retinal nerve fibre layer thickness
Total retinal thickness measured in micrometers by OCT
Measured: 6, 12 and 24 months
Disc global volume
Disc global volume measured in micrometers cubed by OCT
Measured: 6, 12 and 24 months
Disc central thickness
Disc central thickness measured by OCT (micrometers)
Measured: 6, 12 and 24 months
Disc maximum height
Disc maximum height measured by OCT (micrometers)
Measured: 6, 12 and 24 months
Macular ganglion cell layer volume
Macular ganglion cell layer volume as measured by OCT in micrometers cubed
Measured: over 6, 12 and 24 months
Visual acuity
Visual acuity, measured by logarithm of the minimum angle or resolution (LogMAR) units. Visual acuity (VA) is measured on the logMAR scale by sight tests in clinic using Early treatment diabetic retinopathy study (ETDRS) charts at 4 meters. Values are taken for each eye separately, both uncorrected, and corrected with glasses or contact lenses, and can range from 0, which represents perfect vision i.e. 20/20 (values of-0.1 and -0.2 are also possible representing better than perfect vision), to +2 which represents near blindness i.e. 20/2000. Increases in logMAR represent deterioration in vision.
Measured: Over 6, 12 and 24 months
Humphrey Visual Fields (HVF) Perimetric Mean Deviation (PMD)
Humphrey Visual Fields (HVF) 24-2 SITA standard visual field test measured by Perimetric Mean Deviation (PMD). Visual threshold is the intensity of stimulus seen 50% of the time at each location. Higher numbers mean the patient was able to see a more attenuated light, and thus has more sensitive vision at that location. The numerical total deviation map compares the patient's visual sensitivity to an average normal individual of the same age. It is useful to compare with age-matched normal thresholds as sensitivity normally decreases gradually with age. Positive values represent areas of the field where the patient can see dimmer stimuli than the average individual of that age. Negative values represent decreased sensitivity from normal. Reliability indices, including fixation losses, false positives, and false negatives are also included.
Measured: Over 6, 12 and 24 months
Proportion of patients re-presenting to hospital within 30 days post-intervention
Proportion of patients re-presenting to hospital within 30 days post-intervention. Percentage
Measured: 30 days
Proportion of patients being re-admitted to hospital within 30 days post-intervention.
Proportion of patients being re-admitted to hospital within 30 days post-intervention. Percentage
Measured: 30 days
Proportion of major complication, defined as the incidence of complications graded between III and V or major anaesthesia problems (including complications from revision procedures) according to the Clavien-Dindo classification of surgical complications
Measured by the Clavien-Dindo classification of surgical complications. The Clavien-Dindo scale is a validated, 5-grade, ordinal scale used to grade surgical complications based on the therapeutic interventions required to manage them. It provides a standardised, objective method for reporting postoperative morbidity (grades I-IV) and mortality (grade V), with increasing severity based on the level of care, from minor bedside treatment to ICU-level support or death.
Measured: over 6, 12 and 24 months
Proportion with minor complications, defined as Clavien-Dindo grade I-II during hospital stay.
Measured by the Clavien-Dindo scale; grade I-II. The Clavien-Dindo scale is a validated, 5-grade, ordinal scale used to grade surgical complications based on the therapeutic interventions required to manage them. It provides a standardized, objective method for reporting postoperative morbidity (grades I-IV) and mortality (grade V), with increasing severity based on the level of care, from minor bedside treatment to ICU-level support or death.
Measured: Over 6, 12 and 24 months
Proportion of patients requiring revision in whom the revision intervention is the same as the primary intervention
Percentage
Measured: over 6, 12 and 24 months
Proportion of patients requiring revision in whom the revision intervention crosses over to the alternative intervention
percentage
Measured: over 6, 12 and 24 months
Time to first revision
measured in days from day of intervention to day of first revision
Measured: measured in days over 6, 12 and 24 months
Number of revisions per patient
number
Measured: over 6, 12 and 24 months
Proportion of patients with Adverse Events grade 3 or above measured by the CTCAE version 5.
CTCAE v5. In the CTCAE, symptoms are categorised by organ system, ranging from mild (Grade 1) to death (Grade 5)
Measured: Over 6, 12 and 24 months
Monthly headache days
number of days per month with headache reported
Measured: over 6, 12, and 24 months
Monthly moderate to severe headache days
Measured by number of headache days per month with a severity greater than or equal to 4. 0-10 scale where 0 is no headache and 10 is the worst imaginable headache. Scores between 4 and 10 will be considered moderate to severe.
Measured: over 6, 12 and 24 months
Headache severity (numeric rating scale (NRS) 0-10)
Headache severity measured by (numeric rating scale (NRS) 0-10) where 0 is no headache and 10 is the worst headache
Measured: over 6, 12 and 24 months
Moderate to severe headache severity (NRS greater than or equal to 4)
Headache severity measured by (numeric rating scale (NRS) 0-10) where 0 is no headache and 10 is the worst headache. Moderate to severe headache severity (NRS greater than or equal to 4)
Measured: Over 6, 12 and 24 months
Monthly use of acute headache analgesics
number of days per month where analgesics are used to treat headaches as documented on the concomitant medication form and the headache diary.
Measured: over 6, 12 and 24 months
Quality of Recovery 15 (QoR-15) measured at time of discharge
QoR 15 is a validated, 15-item patient-reported questionnaire used to measure the quality of recovery after surgery and anaesthesia, with a maximum score of 150 indicating excellent recovery.
Measured: At time of discharge (usually within 7 days of intervention)
Satisfaction with intervention (5-point Likert scale) measured at time of discharge
5-point Likert scale with 1 - Very Unsatisfied and 5 - Very Satisfied
Measured: At time of discharge (usually within 7 days)
Visual Function Questionnaire (NEI-VFQ-25 with 10-Item Neuro-Ophthalmic Supplement)
measure of visual function using a composite score ranging from 0-100, where higher scores indicate better function.
Measured: Over 6, 12 and 24 months
Headache Impact Test (HIT-6)
6-question tool that measures the impact of headaches on daily life, producing a total score between 36 and 78. Higher scores indicate greater severity. Scores of 60+ indicate a very severe, 56-59 a substantial, 50-55 some, and 49 or less little to no impact.
Measured: Over 6, 12 and 24 months
36-item Short form health survey (SF-36v2)
A patient-reported tool measuring eight health domains, scoring them from 0 to 100, where 0 represents maximum limitations and 100 represents no health restrictions
Measured: Over 6, 12 and 24 months
EuroQol 5 dimension 5 level survey (EQ5D-5L)
The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale from 0 "worst imaginable health" to 100 "best imaginable health"
Measured: Over 6, 12 and 24 months
Time to return to work (if working)
fewer days to return to work is better than more days to return to work
Measured: Measured in days from date of intervention for the duration of follow up: reported over 6, 12 and 24 months
Work Productivity and Activity Impairment Questionnaire - General Health (WPAI-GH)
The WPAI measures absenteeism, presenteeism and activity impairment attributable to ill-health over the preceding 7 days.
The WPAI calculates percentage impairment (maximum 100%) with higher numbers representing greater work impairment.
Measured: Over 6, 12 and 24 months
Proportion of patients requiring ICP lowering medication above a clinically relevant threshold
Measured as a percentage of patients reporting use of ICP lowering medications
Measured: Over 6, 12 and 24 months
Healthcare resource use questionnaire
Designed to calculate how much healthcare resource is used by each patient since the last clinic visit. This assesses the economic impact of IIH and will record any major differences in cost per QALY gained on each arm of the trial
Measured: over 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start18 Jul 2023
- Primary completion28 Aug 2027 (estimated)
- Study completion28 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IIH - Idiopathic Intracranial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440277
- Sponsor's protocol ID
- RG_21-078
- Other IDs
- IRAS 314408
- Acronym
- Intervention
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention To Preserve Vision In Idiopathic Intracranial Hypertension: Evaluation Of Clinical Effectiveness And Cost Effectiveness (IIH Intervention)
- ClinicalTrials.gov ID
- NCT07440277
- Acronym / sponsor ID
- Intervention / RG_21-078
- Keywords
- DVSS, dural venous sinus stent, stent, shunt, intracranial pressure, stenosis, papilloedema, visual loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 28 Aug 2027 (estimated)
- Study completion
- 28 May 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and study aims 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 a 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. Participants will have the same chance to be treated with CSF shunting or DVSS. The aim of the trial is to know which intervention is the most effective to save the vision and the most cost-effective.
Who can participate? Adults with a diagnosis of IIH at risk of permanent sight loss
What does the study involve? The trial will be conducted in NHS hospitals located in England, Wales and Scotland. Participants are randomly allocated to undergo cerebrospinal fluid (CSF) shunting or dural venous sinus stenting (DVSS). Afterwards the participants will be asked to attend 11 hospital appointments and one telephone appointment. This follow-up will take 2 years from start to finish. Participants will be closely monitored for any side effects and potential device failure, and for changes in vision, headaches and quality of life. The researchers will also collect health data from NHS Digital (the national custodian of NHS health and social care data).
What are the possible benefits and risks of participating? There are no direct benefits from taking part in the trial but the information gained from this trial may help improve treatment for adults with IIH in the future. Participants may be seen more often and/or feel more supported as a consequence of their involvement in the trial. As with any intervention, there are risks and complications, but there are no additional disadvantages or risks involved in taking part in this trial. Both CSF shunting and stenting are treatments for IIH (shunting is widely used internationally, and in some hospitals, stenting is used as part of the standard of care). Participants require an intervention to prevent sight loss. None of these treatments is experimental but at present, there is not enough information to determine which treatment is most suitable and provides the higher level of health benefits to the individual.
Where is the study run from? University of Birmingham (UK)
When is the study starting and how long is it expected to run for? The first site opened in July 2023, and the last patient last visit is expected in May 2028
Who is funding the study? National Institute for Health Research (NIHR, grant number: NIHR131211) (UK)
Who is the main contact? IIH Intervention Trial manager, IIHIntervention@trials.bham.ac.uk (UK)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSF shunting | Active comparator | Device: CSF shuntCerebrospinal fluid shunt |
| DVSS | Experimental | Device: DVSSDural Venous Sinus Stenting |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of IIH by the IIH consensus guidelines with papilloedema and at risk of visual loss.
- Presence of papilloedema (Frisén grade ≥ 3) in at least one eye
- Age 18 to < 64 years at the time of consent.
- Patients must be suitable for and willing to proceed with both CSF shunting (VP or Lumboperitoneal shunts only) and DVSS.
- Able to provide written informed consent.
Key exclusion criteria (22 listed)
- Presence of current venous sinus thrombosis on diagnostic brain imaging by either MRI, MRV or CTV
- Previous surgery for IIH including, optic nerve sheath fenestration, CSF shunting procedures, sub-temporal decompression and DVSS.
- Previous bariatric surgery within the last 3 months
- Patients with a past ophthalmic history, except refraction error, affecting the eligible eyes (study eyes) that could affect the vision.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSF shuntCSF shunt may be ventriculoperitoneal (VP) or lumboperitoneal (LP) at the discretion of the treating medical team. | Device | CSF shunting |
| DVSSDural Venous Sinus Stent. Exact make and model of device not mandated by protocol. | Device | DVSS |
Primary outcome
Global thickness of the retinal nerve fibre layer (RNFL) over 6 months, as measured by OCT
Time frame: 6 months
Global thickness of the retinal nerve fibre layer (RNFL) over 6 months, as measured in micrometers by OCT
32 secondary outcomes
Global thickness of the retinal nerve fibre layer (RNFL)
Time frame: 12 months, 24 months
Total retinal nerve fibre layer thickness
Time frame: 6, 12 and 24 months
Disc global volume
Time frame: 6, 12 and 24 months
Disc central thickness
Time frame: 6, 12 and 24 months
Disc maximum height
Time frame: 6, 12 and 24 months
Macular ganglion cell layer volume
Time frame: over 6, 12 and 24 months
Visual acuity
Time frame: Over 6, 12 and 24 months
Humphrey Visual Fields (HVF) Perimetric Mean Deviation (PMD)
Time frame: Over 6, 12 and 24 months
Proportion of patients re-presenting to hospital within 30 days post-intervention
Time frame: 30 days
Proportion of patients being re-admitted to hospital within 30 days post-intervention.
Time frame: 30 days
Proportion of major complication, defined as the incidence of complications graded between III and V or major anaesthesia problems (including complications from revision procedures) according to the Clavien-Dindo classification of surgical complications
Time frame: over 6, 12 and 24 months
Proportion with minor complications, defined as Clavien-Dindo grade I-II during hospital stay.
Time frame: Over 6, 12 and 24 months
Proportion of patients requiring revision in whom the revision intervention is the same as the primary intervention
Time frame: over 6, 12 and 24 months
Proportion of patients requiring revision in whom the revision intervention crosses over to the alternative intervention
Time frame: over 6, 12 and 24 months
Time to first revision
Time frame: measured in days over 6, 12 and 24 months
Number of revisions per patient
Time frame: over 6, 12 and 24 months
Proportion of patients with Adverse Events grade 3 or above measured by the CTCAE version 5.
Time frame: Over 6, 12 and 24 months
Monthly headache days
Time frame: over 6, 12, and 24 months
Monthly moderate to severe headache days
Time frame: over 6, 12 and 24 months
Headache severity (numeric rating scale (NRS) 0-10)
Time frame: over 6, 12 and 24 months
Moderate to severe headache severity (NRS greater than or equal to 4)
Time frame: Over 6, 12 and 24 months
Monthly use of acute headache analgesics
Time frame: over 6, 12 and 24 months
Quality of Recovery 15 (QoR-15) measured at time of discharge
Time frame: At time of discharge (usually within 7 days of intervention)
Satisfaction with intervention (5-point Likert scale) measured at time of discharge
Time frame: At time of discharge (usually within 7 days)
Visual Function Questionnaire (NEI-VFQ-25 with 10-Item Neuro-Ophthalmic Supplement)
Time frame: Over 6, 12 and 24 months
Headache Impact Test (HIT-6)
Time frame: Over 6, 12 and 24 months
36-item Short form health survey (SF-36v2)
Time frame: Over 6, 12 and 24 months
EuroQol 5 dimension 5 level survey (EQ5D-5L)
Time frame: Over 6, 12 and 24 months
Time to return to work (if working)
Time frame: Measured in days from date of intervention for the duration of follow up: reported over 6, 12 and 24 months
Work Productivity and Activity Impairment Questionnaire - General Health (WPAI-GH)
Time frame: Over 6, 12 and 24 months
Proportion of patients requiring ICP lowering medication above a clinically relevant threshold
Time frame: Over 6, 12 and 24 months
Healthcare resource use questionnaire
Time frame: over 6, 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Trial WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSF shunt and DVSS in people with IIH - Idiopathic Intracranial Hypertension, run by University of Birmingham at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Sinclair, MBChB, FRCP, PhD (+44 121 414 8040, a.b.sinclair@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global thickness of the retinal nerve fibre layer (RNFL) over 6 months, as measured by OCT (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.