Positive Airway Pressure and Intraocular Relationship: Study 2- The Impact of CPAP on Nocturnal IOP.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Intraocular pressure (IOP)
研究概览
简要总结
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); 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, untreated OSA with indications for CPAP
- •Age >40 years
- •Able to give informed consent and attend for the study visits.
排除标准
- •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
- •Acute infectious diseases
- •Inability to undergo screening ophthalmic examination
结局指标
主要结局
Intraocular pressure (IOP)
时间窗: On completion of study visit 2: 6 weeks
Difference between baseline IOP at night and nocturnal IOP on CPAP
次要结局
- Optic disc vessel density(On completion of study visit 2: 6 weeks)
- Relationship between change in IOP on CPAP with OSA severity(On completion of study visit 2: 6 weeks)
- Peripapillary vessel density(On completion of study visit 2: 6 weeks)
- Diurnal IOP change(On completion of study visit 2: 6 weeks)
- Differences in change in IOP between the study group(On completion of study visit 2: 6 weeks)
- Relationship between change in IOP on CPAP with POAG severity(On completion of study visit 2: 6 weeks)
- Ocular Perfusion Pressure (OPP)(On completion of study visit 2: 6 weeks)