diabetic retinopathy, diabetic macular oedema
Conditions
Interventions
Group 1:Noctura 400 (0.03 scotopic troland) sleep mask
Group 2:Noctura 400 (2 scotopic trolands) sleep mask
Sponsors
Research Fund Secretariat, Food and Health Bureau, The Government of HKSAR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults (over 18 years old); 2. DM type 1 or 2; 3. Presence of diabetic macular oedema (DMO); 4. Patients who can give an HbA1c level throughout the study; 5. No previous treatments within 6months of baseline visit; 6. Any stage of non-proliferative diabetic retinopathy.
Exclusion criteria
Exclusion criteria: 1. Minors (under 18 years old); 2. Pregnant; 3. Advanced cataract or other media opacity which precludes a fundal view; 4. Any proliferative diabetic retinopathy including advanced diabetic eye disease (vitreous haemorrhage or tractional retinal detachment). 5. Unstable or poorly controlled diabetes (HbA1c levels >15); 6. Contraindications listed in the instruction of Noctura 400; 7. Unable to complete giving consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity (BCVA);Macular thickness in each zone of the ETDRS Grid;Maximum retinal thickness, average central subfield thickness (CST), central maximum thickness (Cmax);Other anatomical changes;Diabetic retinopathy severity level;Number of standard treatments required (Anti-VEGF injections, laser, etc.);Microperimetry; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of using the Noctura 400; | — |
Countries
China
Contacts
Public ContactDr Marten Erik Brelén
Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong
Outcome results
None listed