Diabetic retinopathy Eye Diseases Moderate proliferative, or non-proliferative retinopathy and progressive Diabetic Macular Edema (DME)
Conditions
Interventions
All participants, having been screened and consented, are given a light-emitting sleep mask to be worn each night for 6 months. The masks emit a low intensity, green light (peak wavelength 504±5nm and
Sponsors
PolyPhotonix Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Diabetic macular edema (DME) greater than 220um (central subfield thickness) in either eye
Exclusion criteria
Exclusion criteria: Patients presenting with significant coneal opacity that precludes OCT and fundus photography.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Best corrected visual acuity (VA) is assessed at a distance of 4 metres using ETDRS boards at baseline, 3 and 6 months 2. Macular thickness is assessed by spectral domain optical coherence tomography (OCT) at baseline, 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Compliance with treatment is assessed by mask usage time (recorded by the masks) after 6 months of use 2. Experience of use is assessed using a questionnaire (specially designed for the purpose of this study) after 6 months of use 3. Control of diabetes is assessed by measuring glycated haemoglobin (HbA1c) at baseline and 6 months | — |
Countries
Czech Republic
Contacts
Public ContactLuke Barclay
Outcome results
None listed