PICMO: Monitoring ICP using ophthalmological imaging in children
Research type
Research Study
Full title
PICMO - Paediatric Intracranial Hypertension: Monitoring intracranial pressure using ophthalmological imaging
IRAS ID
337071
Contact name
Akudziwe Mawere
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
Duration of Study in the UK
3 years, 0 months, 31 days
Research summary
Intracranial hypertension, or raised pressure inside the skull, is a condition that can affect children with different conditions such as brain tumours, head injuries, and craniosynostosis. If left untreated, the raised pressure can cause damage to the growing brain resulting in loss of vision, disability, and in severe cases death.
Accurate measurement and monitoring of the pressure is therefore necessary. Currently, the gold standard method of doing this is a specialised pressure sensing device which is placed surgically directly onto the brain. Because of the risks associated with the procedure such as bleeding and infection, and the need for an overnight hospital stay, we can't monitor the pressure in everyone. It is usually indicated for patients with severe symptoms. In patients with milder symptoms, therefore, it can be difficult to decide when to monitor the pressure, and impractical to repeat monitoring each time symptoms change.
Our study will investigate non-invasive ways of monitoring the pressure through eye assessments, using optical coherence tomography (OCT), OCT-angiography (OCT-A), and optic nerve sheath ultrasound (ONS-US). OCT uses light to obtain images of the retina, and OCT-A is a complementary technique that assesses blood flow over the retina to distinguish changes due to pressure from anatomical abnormalities. ONS-US uses sound to obtain the images.
We aim to assess children (0 to 18 years) who have been admitted to the John Radcliffe Hospital for pressure monitoring. They will undergo the above eye assessments before, during, and after the pressure monitoring surgery in theatre as they are under anaesthesia. Additional assessments will be done at follow-up clinics. There will be no deviation from standard clinical care. The study will last 3 years, and participants will be followed up during this period whenever they come for related clinics, as detected by their clinical care team.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0215
Date of REC Opinion
19 Aug 2024
REC opinion
Further Information Favourable Opinion