ISRCTN95411896已完成未知
A randomised controlled trial of continuous positive airway pressure (CPAP) in patients with impaired vision due to diabetic Retinopathy and concurrent Obstructive Sleep Apnoea (OSA): ROSA trial
ewcastle upon Tyne NHS Foundation Trust (UK)0 个研究点目标入组 131 人开始时间: 2012年5月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 131
研究概览
简要总结
2018 results in (added 01/10/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 08/02/2013:
- •1. Type II diabetes mellitus (diagnosed on standard criteria), on diet, exercise and/or drug/insulin treatment
- •2. Visual impairment in at least one eye due to diabetes
- •3. Best corrected visual acuity (BCVA) = 39 and = 78 letters in at least one eye (using Early Treatment Diabetic Retinopathy Study protocol (ETDRS) at a testing distance of 4 meters)
- •4. Residual vision in one or both eyes
- •5. Macular oedema in the visually impaired eye(s)
- •6. 4% ODI = 20/hour on the screening study
- •7. Aged =30 to =85
- •8. Patient willing to have nasal CPAP treatment
- •Previous inclusion criteria until 08/02/2013:
- •1. Type II diabetes mellitus (diagnosed on standard criteria), on diet, exercise and/or drug/insulin treatment
- •2. Visual impairment in at least one eye due to diabetes
- •3. Best corrected visual acuity (BCVA) = 39 and = 78 letters in at least one eye (using Early Treatment Diabetic Retinopathy Study protocol (ETDRS) at a testing distance of 4 meters)
- •4. Residual vision in one or both eyes
- •5. Macular oedema in the visually impaired eye(s)
- •6. Diagnosis of macular oedema within last 5 years
- •7. 4% ODI = 20/hour on the screening study
- •8. Aged =30 to =85
- •9. Patient willing to have nasal CPAP treatment
排除标准
- •1. Type 1 diabetes mellitus
- •2. Previous treatment with CPAP or non-invasive ventilation for OSA
- •3. Any severe complication of OSA syndrome requiring CPAP
- •4. Substantial problems with sleepiness, for example while driving
- •5. Respiratory failure (awake resting arterial oxygen saturation <93%)
- •6. Cataract affecting vision such that fundal assessment at baseline on slit lamp/photography is inadequate
- •7. Previous ophthalmological intervention rendering visual improvement in at least one eye very unlikely, as assessed by recruiting ophthalmologist
- •8. Mental or physical disability precluding informed consent or compliance with the protocol for the duration of the study
研究者
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