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Search / Trial NCT06436820

ICP & Outflow Study

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · May 24, 2024

Trial Information

Current as of February 08, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This study aims to investigate the relationship between intracranial pressure (ICP) and aqueous outflow (the flow of the eye's internal fluid out of the eye), in patients with increased intracranial pressure (idiopathic intracranial hypertension (IIH)).

The effect of lowering intracranial pressure on aqueous outflow will be examined by taking additional measurements before and after a procedure called a lumbar puncture (LP). These measurements include a scan to measure the dimensions of the eye, intraocular pressure reading, and a non-invasive technique to measure aqueous outflow (electron...

Gender

ALL

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.

About Guy's And St Thomas' Nhs Foundation Trust

Guy's and St Thomas' NHS Foundation Trust is a leading healthcare organization in the United Kingdom, renowned for its commitment to delivering high-quality patient care, innovative research, and clinical excellence. As a prominent academic health science center, the Trust integrates cutting-edge research with clinical practice, facilitating the translation of scientific discoveries into improved treatment options. With a diverse portfolio of clinical trials across various medical specialties, Guy's and St Thomas' NHS Foundation Trust plays a pivotal role in advancing healthcare knowledge and enhancing patient outcomes, while maintaining the highest ethical standards in research and patient safety.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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