Open Angle Glaucoma Clinical Trial
— POSAGOfficial title:
POSAG: Prevalence of Obstructive Sleep Apnoea in Glaucoma
Verified date | November 2017 |
Source | Papworth Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to investigate a potential link between Obstructive Sleep Apnoea (OSA) and Open Angle Glaucoma (OAG); initially by determining whether the prevalence of OSA is higher in patients with OAG in comparison to people without glaucoma and if OSA is an independent risk factor for OAG. It will comprehensively phenotype glaucoma patients for variables that may be associated with both OSA and OAG.
Status | Completed |
Enrollment | 403 |
Est. completion date | September 14, 2017 |
Est. primary completion date | September 14, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Glaucoma patients: 1. Open angle glaucoma (including primary open angle glaucoma, normal tension glaucoma and pseudoexfoliation glaucoma) in either eye. 2. Age =18 years 3. Able to give informed consent and attend at the required frequency for the duration of the study. Control group: 1. Age =18 years 2. Able to give informed consent and attend at the required frequency for the duration of the study. Exclusion Criteria: Glaucoma patients: 1. Unable to perform reliable visual field testing (>15% false positives, >20% fixation losses. However, if fixation losses are >20%, the eye tracker may be used to assess reliability) 2. Known or suspected pregnancy. 3. Tracheostomy 4. Use of nocturnal oxygen for indications other than sleep related breathing disorders (SBD). Control group: 1. Known or suspected pregnancy 2. Known or suspected glaucoma (participants with glaucoma diagnosed during screening ophthalmic examination and newly identified glaucoma 'suspects' will also be excluded) 3. Inability to undergo screening ophthalmic examination 4. Tracheostomy 5. Use of nocturnal oxygen for indications other than sleep related breathing disorders (SBD). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hinchingbrooke Hospital NHS Foundation Trust | Huntingdon | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Papworth Hospital NHS Foundation Trust | Anglia Ruskin University, Hinchingbrooke Healthcare NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of OSA | Clinical diagnosis of OSA defined as apnoea hypopnoea index (AHI) >5 | Within 24 hours of recruitment on to study (cross-sectional) | |
Secondary | OSA severity | OSA severity will be determined by Apnoea-Hypopnea Index (AHI) and nocturnal oxygen desaturation levels (recording from nocturnal oximetry), which are used to indicate the severity of obstructive sleep apnoea. | 24 hours | |
Secondary | Glaucoma severity | Glaucoma severity measured by mean deviation (MD) derived from visual fields examination | 24 hours | |
Secondary | Ocular perfusion pressure (OPP) | Ocular perfusion pressure will be calculated based on the following formula : OPP=2/3MAP-CVRP where MAP is mean arterial pressure and CVRP is central retinal venous pressure measured by ophthalmodymamometry. | 24 hours | |
Secondary | Postural changes in intraocular pressure (IOP) | Postural changes of IOP will be measured as the difference between IOP in the upright position and then supine position. | 24 hours | |
Secondary | Optic nerve head perfusion | Optic nerve head flow index will be measured non-invasively by Angiographic Ocular Coherence Tomography (aOCT) | 24 hours | |
Secondary | Structural changes of the optic nerve | Structural changes of the optic nerve will be characterised by retinal nerve fibre layer (RNFL) thickness measured by Ocular Coherence Tomography | 24 hours | |
Secondary | Stop-Bang questionnaire as screening tool | Sensitivity and specificity of Stop-Bang questionnaire in detecting OSA in OAG, using Stop-Bang questionnaire summary score. | 24 hours | |
Secondary | Nocturnal oximetry as screening tool | Sensitivity and specificity of nocturnal oximetry in detecting OSA in OAG | 24 hours | |
Secondary | Diagnosis of obstructive sleep apnoea syndrome (OSAS) | Prevalence of OSAS in OAG patients | 24 hours |
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