Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT06436820
Eligibility Criteria:
Inclusion Criteria:
* Males or female between the ages of 18 and 80 (inclusive).
* Able to understand the study and give informed consent.
* Willing, able and available to participate in all aspects of the study.
* Able to undergo accurate tonography.
* Diagnosis of Idiopathic intracranial hypertension (IIH) or suspected diagnosis of IIH as determined by a consultant subspecialist neurologist or neuro-ophthalmologist.
Control group will only include:
* Individuals requiring lumbar puncture as part of their standard care for reasons other than suspected raised intracranial pressure e.g. for cerebrospinal fluid (CSF) sampling to analyse oligoclonal bands or other conditions necessitating lumbar puncture for diagnostic/prognostic purposes.
* Individuals suspected of having a raised intracranial pressure but, upon measurement of the opening pressure, are found to have an intracranial pressure within normal limits.\*
* In this study, where there are considered to be signs of raised intracranial pressure as judged by a consultant neuro ophthalmologist or neurologist, in combination with an opening CSF pressure 20cmH2O or greater, this will be taken as a raised intracranial pressure. Normal CSF pressure is taken as 19cmH2O or lower. In asymptomatic patients, pressures of up to 25cmH2O will be considered normal.
Exclusion Criteria
* Under 18 or over 80 years of age.
* Diagnosis of ocular hypertension (ocular hypertension is defined as any individual with an intraocular pressure above 24mmHg measured on Goldman tonometry, irrespective of corneal thickness. This applies to intraocular pressure measured historically as well on the day of assessment).
* Diagnosis of glaucoma of any subtype (glaucoma is defined on the basis of any glaucomatous optic nerve head appearance \[including that defined on the basis of optic nerve head optical coherence tomography\] or visual field defect, irrespective of intraocular pressure).
* Diagnosis of any significant retinal, corneal or other ocular abnormality aside from optic nerve head oedema secondary to raised ICP.
* Previous intraocular surgery or any surgery in which the conjunctiva has been breached e.g. optic nerve sheath fenestration or squint surgery.
* Diagnosis of raised intracranial pressure secondary to space occupying lesions.
* Any central nervous system or other systematic disorder that is likely to make lumbar puncture high risk or likely to render accurate recording of opening pressures unreliable.
* Mental impairment conflicting with informed consent.
* Patients who might not adequately understand written information given in English or verbal explanations in English will not be included as participants in the study must be able to understand English to complete some of the tests.
* Participants will not be included if they are involved in research deemed by the investigators to impact the outcomes of this study.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06436820
Study Brief:
Protocol Section:
NCT06436820