Journal Article

Recognition of intracranial hypertension using handheld optical coherence tomography in children (RIO Study): a diagnostic accuracy study protocol

Bunce, Catey, Jeelani, Noor ul Owase, Proudlock, Frank A, Gottlob, Irene, Rufai, Sohaib R, Bowman, Richard

2022

Overview

IntroductionPaediatric intracranial hypertension (IH) is a rare but serious condition that can pose deleterious effects on the brain and vision. Estimating intracranial pressure (ICP) in children is difficult. Gold standard direct ICP measurement is invasive and carries risk. It is impractical to routinely perform direct ICP measurements over time for all children at risk of IH. This study proposes to assess the diagnostic accuracy of handheld optical coherence tomography (OCT), a non-invasive ocular imaging method, to detect IH in children.Methods and analysisThis is a prospective study evaluating the diagnostic accuracy of handheld OCT for IH in at risk children. Inclusion criteria include clinical and/or genetic diagnosis of craniosynostosis, idiopathic intracranial hypertension, space occupying lesion or other conditions association with IH and age 0–18 years old. Exclusion criteria include patients older than 18 years of age and/or absence of condition placing the child at risk of IH. The primary outcome measures are handheld OCT and 48-hour ICP assessments, which will be used for diagnostic accuracy testing (sensitivity, specificity, positive predictive value, negative predictive value and accuracy). Main secondary outcome measures include visual acuity, fundoscopic examination, contrast sensitivity, visual field testing and visual evoked potentials, wherever possible.Ethics and disseminationEthical approval was granted for this study by the East Midlands Nottingham 2 Research Ethics committee (UOL0348/IRAS 105137). Our findings will be disseminated through presentation at relevant meetings, peer-reviewed publication and via the popular media.Trial registration numberISRCTN52858719

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Accuracy / Adolescent / Birth defects / Body mass index / Child / Child, Preschool / Consent / Cooperation / Evoked Potentials, Visual / General anesthesia / Guardians / Humans / Hypertension / Infant / Infant, Newborn / Intracranial Hypertension - diagnostic imaging / Intracranial Pressure / Medical diagnosis / neuro-ophthalmology / Neurosurgery / Ophthalmology / Optic nerve / Optics / paediatric neurology / paediatric neurosurgery / paediatric ophthalmology / paediatric plastic & reconstructive surgery / Pathology / Patients / Pediatrics / Prospective Studies / Success / Tomography / Tomography, Optical Coherence - methods / Volumetric analysis