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

Sahni, JN, Czanner, G, Gutu, T, Taylor, SA, Bennett, KM ORCID: 0000-0003-3164-6894, Wuerger, SM ORCID: 0000-0003-0080-5813, Grierson, I, Murray-Dunning, C, Holland, MN and Harding, SP ORCID: 0000-0003-4676-1158 (2017) Safety and acceptability of an organic light-emitting diode sleep mask as a potential therapy for retinal disease. Eye, 31 (1). pp. 97-106.

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Abstract

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

Item Type:	Article
Uncontrolled Keywords:	Medscape
Depositing User:	Symplectic Admin
Date Deposited:	09 Feb 2017 15:29
Last Modified:	19 Jan 2023 07:19
DOI:	10.1038/eye.2016.259
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3005681