Primary Open-angle Glaucoma Clinical Trial
— PAIR2Official title:
Positive Airway Pressure and Intraocular Relationship: Study 2- The Impact of CPAP on Nocturnal IOP.
NCT number | NCT03145129 |
Other study ID # | P02145 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 24, 2017 |
Est. completion date | February 10, 2018 |
Verified date | June 2018 |
Source | Papworth Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Some people with Primary Open-angle Glaucoma (POAG) also suffer from Obstructive Sleep Apnoea
(OSA), a common sleep disorder which is known to affect heart and blood vessels, and may
contribute to glaucoma progression. Obstructive Sleep Apnoea is treated with Continuous
Positive Airway Pressure (CPAP)Íž however using this type of breathing support may raise
intraocular pressure (IOP). The evidence for this is limited and the potential mechanisms
involved are poorly understood.
In this study we will determine whether CPAP applied at night changes IOP and ocular
perfusion pressure (OPP). We will also assess its possible impact on ocular microvasculature.
Two groups of patients will be included: those with POAG and OSA, and those with OSA without
glaucoma. They will attend for two overnight assessments: the first before starting CPAP and
the second 4-6 weeks into the treatment. Repeated measurements of IOP at night will be
performed and participants will continue self-measuring IOP at home in the day. An Ocular
Coherence Tomography Angiography (OCT Angiography) of the optic disc and the surrounding
retina will be performed at baseline and after a few weeks of CPAP treatment.
Status | Completed |
Enrollment | 28 |
Est. completion date | February 10, 2018 |
Est. primary completion date | February 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Newly diagnosed, untreated OSA with indications for CPAP - Age >40 years - Able to give informed consent and attend for the study visits. Exclusion Criteria: - Known or suspected pregnancy - Any contraindications to rebound tonometry, including: corneal scarring, microphtalmos, buphthalmos, nystagmus, keratoconus, abnormal central corneal thickness, corneal ectasia, , active corneal infection, , and corneal dystrophies - Eye diseases known to affect IOP, including: treated wet age related macular degeneration (ARMD), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), uveitis and diabetic retinopathy. - Indications to start CPAP treatment urgently unless the study visits can be organised in a way there is no delay in treatment initiation. - Irregular sleep pattern - Insomnia - Acute infectious diseases - Inability to undergo screening ophthalmic examination |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Papworth Hospital | Cambridge |
Lead Sponsor | Collaborator |
---|---|
Papworth Hospital NHS Foundation Trust | Hinchingbrooke Healthcare NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraocular pressure (IOP) | Difference between baseline IOP at night and nocturnal IOP on CPAP | On completion of study visit 2: 6 weeks | |
Secondary | Diurnal IOP change | A difference in diurnal IOP self-measured at home at baseline and during CPAP treatment. | On completion of study visit 2: 6 weeks | |
Secondary | Differences in change in IOP between the study group | Differences in IOP change (?IOP; IOPCPAP -IOPbaseline) between the groups | On completion of study visit 2: 6 weeks | |
Secondary | Relationship between change in IOP on CPAP with OSA severity | Correlation between IOP change (?IOP) and AHI (Apnoea-Hypopnoea Index) | On completion of study visit 2: 6 weeks | |
Secondary | Relationship between change in IOP on CPAP with POAG severity | Correlation between IOP change (?IOP) and VFI (Visual Field Index) | On completion of study visit 2: 6 weeks | |
Secondary | Ocular Perfusion Pressure (OPP) | Difference between baseline OPP at night and nocturnal OPP on CPAP in each group | On completion of study visit 2: 6 weeks | |
Secondary | Optic disc vessel density | Optic disc vessel density at baseline and after 4-6 weeks of CPAP treatment | On completion of study visit 2: 6 weeks | |
Secondary | Peripapillary vessel density | Peripapillary vessel density at baseline and after 4-6 weeks of CPAP treatment | On completion of study visit 2: 6 weeks |
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