Safety and acceptability of an organic light-emitting diode sleep mask as a potential therapy for retinal disease

摘要: The purpose of the study was to effect an organic light-emitting diode sleep mask on daytime alertness, wellbeing, and retinal structure/function in healthy volunteers diabetic macular oedema (DMO). Healthy two groups, 18–30 yrs (A), 50–70 (B) people with DMO (C) wore masks (504 nm wavelength; 80 cd/m2 luminance; ≤8 h) nightly for 3 months followed by a 1-month recovery period. Changes from baseline were measured (means): psychomotor vigilance task (PVT) (number lapses (NL), response time (RT)), sleep, depression, psychological wellbeing (PW), visual acuity, contrast sensitivity, colour, electrophysiology, microperimetry, thickness OCT. Of 60 participants, 16 (27%) withdrew, 8 (13%) before month 1, due disturbances intolerance. About 36/55 (65%) who continued beyond 1 reported ≥1 adverse event. At mean PVT worsened Group A (RT (7.65%, P<0.001), NL (43.3%, P=0.005)) PW all groups (A 28.0%, P=0.01, B 21.2%, P=0.03, C 12.8%, P<0.05). No other clinically significant safety signal detected. Cysts reduced/resolved OCT subfield maximal pathology 67% eyes. Thinning greater at 4 (central P<0.001, Sleep showed no major apart small impairment alertness moderate wellbeing. Masks acceptable some participants. Preliminary data suggest beneficial DMO. This novel therapeutic approach is ready large clinical trials.