Primary Open-angle Glaucoma Clinical Trial
Official title:
Positive Airway Pressure and Intraocular Relationship: Study 2- The Impact of CPAP on Nocturnal IOP.
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.
People with OAG and concomitant OSA associated with the relevant symptoms, particularly
daytime sleepiness, currently receive standard treatment with CPAP. However, the impact of
CPAP on their glaucoma is unknown. There are concerns that CPAP increases IOP, currently the
only modifiable factor in glaucoma, though the evidence for this is limited.
Understanding the influence of CPAP on IOP is important as it may inform the management of
people with OSA and concomitant glaucoma. If CPAP is shown to raise IOP or alter OPP to
levels that pose clinical risk it will be necessary to assess available alternative treatment
options for OSA. If, however, CPAP does not alter these parameters, there would be a
rationale for assessing long-term effects of CPAP, most probably in the form of a randomised
interventional trial, informed by the findings of this research.
This is a prospective controlled study which will examine the impact of CPAP on nocturnal IOP
and OPP in people with OSA with and without POAG. In addition, we will assess ocular
microvasculature before and a few weeks into CPAP treatment.
Objectives:
Primary: to determine if IOP increases at night following treatment with CPAP in people with
OSA with and without POAG.
Main Secondary:(i) to investigate whether diurnal IOP raises after CPAP treatment; (ii) to
investigate whether CPAP alters peri-papillary and macular microcirculation measured with OCT
Angiography.
Participants: People with newly diagnosed OSA who require treatment with CPAP will be
invited. We will recruit participants with POAG and people without glaucoma (control
subjects). All participant will undergo a detailed ocular assessment including: visual
acuity, IOP measurement, OCT and visual field test.
Sample Size: 30 participants: 15 per group.
Study Visits:
Visit 0: Baseline ocular examination to confirm or exclude glaucoma will be undertaken during
this visit unless a participant already had this examination within the last 6 months.
Visit 1: Participants will attend the sleep centre (Respiratory Support and Sleep
Centre-RSSC, Papworth Hospital) where they will be admitted to a separate ward. Consented
participants will undergo the following:
Baseline assessment: A brief medical history, spirometry and anthropomorphic measurements.
Repeated measurements: IOP will be measured in each eye using a rebound tonometer (Icare Pro,
Finland Oy). Blood pressure and ocular perfusion pressure will be checked simultaneously.
Participants will be advised to sleep at their habitual hours. Sleep onset and duration will
be recorded. All the above measurements will be repeated every 2 hours starting from 10pm and
finishing at 8am. In the morning OCT Angiographic will be performed.
Participants will then self-measure IOP at home using a rebound tonometer (Icare Home,
Finland Oy). The measurements will be performed in the daytime every 2 hours before they
start CPAP and 4-6 weeks into the treatment.
Visit 2: Participants will return for the second overnight assessment 4-6weeks after
initiation of CPAP treatment.
CPAP usage data will be downloaded. All the measurements following the same procedure as for
Visit 1 will be repeated this time with participants using CPAP. OCT Angiographic will be
performed immediately after removing CPAP in the morning.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01841437 -
Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry
|
N/A | |
Completed |
NCT02077231 -
Study of Vitamin A and Carbomer in Comforting the Ocular Surface Irritations of Glaucoma Patients
|
N/A | |
Completed |
NCT01410188 -
Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
|
Phase 1/Phase 2 | |
Recruiting |
NCT05557058 -
GORE Glaucoma Drainage Implant Clinical Study
|
N/A | |
Not yet recruiting |
NCT03924544 -
Decorin in Sub Scleral Trabeculectomy
|
Phase 1 | |
Active, not recruiting |
NCT03673644 -
Impact of Glaucoma and Visual Field Loss on Life Space
|
||
Completed |
NCT03365778 -
Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment
|
N/A | |
Completed |
NCT01915940 -
Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension
|
Phase 2 | |
Completed |
NCT03889652 -
Optical Coherence Tomography of Nerve Fiber Layer and Ganglion Cell Complex After Cataract Extraction
|
||
Terminated |
NCT03273907 -
Post Approval Study of the CyPass System
|
N/A | |
Recruiting |
NCT03193333 -
PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM)
|
Phase 3 | |
Recruiting |
NCT03921931 -
Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study
|
N/A | |
Not yet recruiting |
NCT04609345 -
Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients
|
||
Recruiting |
NCT05264818 -
Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma
|
||
Completed |
NCT04333433 -
PRESERFLO® MicroShunt Extension Study
|
||
Enrolling by invitation |
NCT02144103 -
Effectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Glaucomatous Neurodegeneration
|
Phase 1/Phase 2 | |
Completed |
NCT01281020 -
Adherence With Fixed Versus Unfixed Glaucoma Therapy
|
||
Recruiting |
NCT04891588 -
Switching From the Preserved to the Preservative - Free Latanoprost - Timolol FC in Glaucoma Patients With OSD
|
N/A | |
Completed |
NCT03104621 -
Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients
|
Phase 4 | |
Completed |
NCT01742104 -
Multicentric Observational Study on Quality of Life in Glaucoma
|
N/A |