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van CCT (UK)


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van CCT (UK)


A method for non-invasive intracranial pressure measurement in glaucoma


- candidate number25505
- NTR NumberNTR6200
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2016
- Secondary IDs201600875 
- Public TitleA method for non-invasive intracranial pressure measurement in glaucoma
- Scientific TitleA method for non-invasive intracranial pressure measurement in glaucoma
- ACRONYM
- hypothesisThe changes in DPOAEs from upright to 30 degrees HDT will be greatest for subjects who are expected to have the lowest ICP (primarily NTG subjects). Alternatively, the least amount of change in DPOAEs will occur in subjects who are expected to have the highest ICP (primarily the high IOP, non glaucomatous subjects).

ICP = Intracranial pressure; IOP = Intraocular pressure; DPOAE = Distortion product otoacoustic emissions
- Healt Condition(s) or Problem(s) studiedGlaucoma
- Inclusion criteria50-70 years of age
Presence of DPOAEs in one ear
For healthy controls: Upright IOP of 21mmHg or lower
For high pressure glaucoma: Diagnosed Glaucoma, upright IOP over 21mmHg before the onset of IOP lowering treatment, and established disease progression rate based on perimetry
For normal tension glaucoma: Diagnosed Glaucoma, upright IOP of 21mmHg or lower with or without IOP lowering treatment, and established disease progression rate based on perimetry
For high IOP with no glaucoma: Upright IOP of 22mmHg or higher
Written informed consent.
- Exclusion criteriaNo presence of DPOAEs
For healthy controls, any eye disease or family history of glaucoma
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 31-jan-2017
- planned closingdate31-jul-2017
- Target number of participants80
- InterventionsN/a
- Primary outcomeThe primary objective is to evaluate the use of DPOAEs as a representation of ICP in Glaucoma patients by investigating changes in DPOAE amplitudes and phase angles with changes in posture in subgroups of glaucoma patients and in healthy controls.
- Secondary outcomeN/a
- TimepointsN/a
- Trial web siteN/a
- statusplanned
- CONTACT FOR PUBLIC QUERIES K. Westra
- CONTACT for SCIENTIFIC QUERIES K. Westra
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Marie Curie
- Publications
- Brief summaryThe relationship between intraocular pressure (IOP) and intracranial pressure (ICP) is a crucial aspect of the pathology of Glaucoma. Alterations in either IOP or ICP that lead to a change in the pressure gradient between the two threaten the neural tissue in the eye and, if left untreated, can lead to blindness. Currently the only reliable methods of measuring ICP are by lumbar puncture or intraventricular catheter, two extremely invasive techniques. It is therefore necessary to establish an accurate non-invasive measurement of ICP for evaluating the cause and progression of Glaucoma. Current research shows that Distortion Product Otoacoustic Emissions (DPOAEs) may be able to accurately represent changes in ICP.
- Main changes (audit trail)
- RECORD3-nov-2016 - 19-feb-2017


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