Continuous positive airway pressure (CPAP) in patients with impaired vision due to diabetic Retinopathy and concurrent Obstructive Sleep Apnoea (OSA): ROSA trial

Not Applicable

Completed

• Conditions: Sleep apnoea; Obstructive sleep apnoea and visual impairment due to diabetic retinopathy; Nervous System Diseases

• Registration Number: ISRCTN95411896
• Lead Sponsor: ewcastle upon Tyne NHS Foundation Trust (UK)

Brief Summary

2018 results in (added 01/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-28
• Study Completion: 2017-01-31
• Last Update Posted: 12 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 131

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified