Patients with Diabetic Eye Disease using a Potentially Therapeutic Mask. Do Sufficient Patients Wear the Mask and For How Long?

Abstract

A single centre, prospective, interventional, open label clinical trial was conducted at Vinohrady Eye Department, Prague to evaluate safety and the mask wearing characteristics of patient volunteers who agreed to night-time use of the Noctura 400 light mask for treatment of diabetic retinopathy (DR). Noctura 400 shines green light through closed lids to prevent dark adaption and elevated retinal oxygen consumption while the patient sleeps. A total of 45 patients with advanced non-proliferative or early proliferative DR were recruited and all had diabetic macular oedema (DME). The patients wore the Noctura 400 mask for up to 8 hours per night for six months with measurements of Visual Acuity and Macular thickness at three monthly intervals. The Noctura 400 mask recorded their nightly use. Of the 45 patients who began the trial, 35 (78%) completed the 6 months of nightly mask wear and no major safety issues were identified. Electronic monitoring showed that patients wore the mask for 4.96 +/-2.97 hours per night and there was no significant lack of persistence over the 6 months trial duration. The average number of missed nights of wear per patient was 34.1+/-39.0. Visual acuity in these patients showed a modest improvement reversing the visual deterioration noted over 10 months prior to recruitment. Also there was central macular thinning in 38.8% of the completing patients. This commercial device appears to be safe, is worn by the majority of patients with some evidence of benefit even in advanced cases of DR.