Paediatric intracranial hypertension Nervous System Diseases Paediatric intracranial hypertension
Conditions
Interventions
Current interventions as of 14/06/2022:
Subjects will be recruited consecutively from the ophthalmology clinic at Great Ormond Street Hospital (GOSH), London, and from the Oxford Crani
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged <18 years 2. Clinical and/or genetic diagnosis of craniosynostosis 3. Clinical diagnosis of other conditions associated with the risk of intracranial hypertension, including idiopathic intracranial hypertension, space-occupying lesions, and hydrocephalus
Exclusion criteria
Exclusion criteria: 1. Not wishing to participate 2. Incapable of giving consent and without a legal guardian willing or able to do so
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 14/06/2022: 1. Optical coherence tomography (OCT) parameters measured using a handheld device (Envisu C2300, Leica Microsystems, Wetzlar, Germany, and Spectralis Flex, Heidelberg Engineering, Heidelberg, Germany) at baseline, follow-up visits (where applicable), and study end. A 12×8-mm scanning window will be used in the acquisition protocol. The 3-dimensional raster scan for both scan sequences will consist of 80 B-scans and 600 A-scans per B-scan line resulting in a short acquisition time (1.9 seconds) enabling imaging of the ONH and fovea with minimal movement artefact 1.1. Cup and disc parameters (cup depth, cup width, disc width, cup to disc ratio) 1.2. Rim parameters (nasal and temporal ppRNFL thickness, rim area, Bruch’s membrane opening-minimum rim width (BMO-MRW), Bruch’s membrane orientation 1.3. Retinal parameters (macular and perimacular retinal thickness, foveal pit width, foveal pit depth, foveal pit area, segmentation of all retinal layers) 2. Intracranial pressure measured over 48 h intraparenchymally using catheter and bolt system (Neurovent-P, RAUMEDIC AG, Helmbrechts, Germany, and Codman ICP Monitor, Integra Lifesciences, Princeton, NJ, United States) at baseline, follow-up visits (where applicable), and study end Secondary outcome measures 1. Visual acuity measured using logMAR chart vision tests (or preferential looking where logMAR chart vision test not possible) wherever possible at baseline, follow-up visits (where applicable), and study end 2. Visual electrophysiology measured using visual evoked potentials (VEPs) wherever possible at baseline, follow-up visits (where applicable), and study end 3. Peripheral vision measured using visual fields testing wherever possible at baseline, follow-up visits (where applicable), and study end 5. Contrast s | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual acuity measured using logMAR chart vision tests (or preferential looking where logMAR chart vision test not possible) wherever possible at baseline, follow-up visits (where applicable), and study end 2. Visual electrophysiology measured using visual evoked potentials (VEPs) wherever possible at baseline, follow-up visits (where applicable), and study end 3. Peripheral vision measured using visual fields testing wherever possible at baseline, follow-up visits (where applicable), and study end 5. Contrast sensitivity measured using contrast sensitivity testing wherever possible at baseline, follow-up visits (where applicable), and study end | — |
Countries
England, United Kingdom
Contacts
Public ContactSam Kerr
Outcome results
None listed