Obstructive sleep apnoea and visual impairment due to diabetic retinopathy Nervous System Diseases Sleep apnoea
Conditions
Interventions
Patients randomised to receive continuous positive airway pressure (CPAP) treatment with standard ophthalmology care, or only standard ophthalmology care.
Sponsors
Newcastle upon Tyne NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity (BCVA) with the study eye at 12 months (LogMAR with refraction, 4 metre Early Treatment of Diabetic Retinopathy Study protocol [ETDRS]) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Best corrected visual acuity (BCVA) with the study eye at 6 months (LogMAR with refraction, 4 metre ETDRS) 2. Optical coherence tomography (OCT) central macular thickness in the study eye at 12 months (central 1mm average of radial line scans) 3. Number of ocular interventions for the study eye over 12 months (such as laser photocoagulation or intraocular injections of anti-VEGF) 4. Progression of diabetic retinopathy in the study eye at 12 months (assessed through retinal photography) 5. CPAP usage (hours/night) | — |
Countries
United Kingdom
Outcome results
None listed