A Real-World Single-Centre Study of Patients with Diabetic Macular Oedema Who Wore a Home-Use Sleep Mask (Noctura 400) for One Year

Abstract

A “Real-World” single-centre observational study was carried out to analyse the effects of enhanced patient interaction with the use of the Noctura 400 sleep mask on a group of 26 diabetics displaying diabetic retinopathy (DR) and diabetic macular oedema (DMO), of which 24 completed the study. We hoped to find if patient compliance could be maintained and to determine the anatomical and functional consequences of consistent mask wear. While this study was ongoing, COVID-19 impacted on normal eye clinic practice, allowing an unexpected analysis of the effects of this disruption to the clinical system on mask wear and disease progress. Throughout the whole study, outcomes were positive, with a high level of consistent patient use of the mask, above 74% up to and beyond 1 year. Even during the COVID-19 1st lockdown in England, the patients maintained a 65% nightly light mask compliance. Statistically significant improvements in maculopathy, including cyst reduction (56.4% of eyes with cysts exhibited cyst shrinkage), and visual acuity (VA) improvement (42/48 eyes gained 5 letters or more) were observed and maintained to the end of the study. Anatomical improvement or stability was recorded in all but one study eye. This investigation shows that given that there is appropriate interaction with patients who are self-treating in home environment, a high level of patient compliance can be maintained, even while there are disruptions to the normal hospital clinic setup.