medwireNews: The CLEOPATRA trial results show that wearing a mask that emits blue–green light during sleep does not reduce the progression of non-central diabetic macular edema.
Wearing such a mask would, in theory, prevent dark adaptation and therefore reduce the oxygen consumption by rod photoreceptors and prevent hypoxia, which could attenuate microvascular damage over time.
But, as reported in The Lancet Diabetes & Endocrinology, maximal retinal thickness declined by an average of 9.2 µm over 24 months among the 144 patients with non-center-involving diabetic macular edema who were randomly assigned to use a light-emitting mask. This was not significantly different to the 12.9 µm reduction among the 133 patients who wore a sham mask.
In a linked commentary, Tien Yin Wong (Singapore National Eye Centre) says that further research is not indicated, based on the “robustness of the CLEOPATRA trial” findings, and highlights also that the intervention is “not sustainable,” given the median compliance at 24 months of only 19.5%.
The results for different levels of compliance were consistent with the overall result, showing a small nonsignificant improvement that was “not close to the detectable effect of 15 μm retinal thickness,” say Sobha Sivaprasad (Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, UK) and study co-authors.
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