Trial in the UK finds no long-term benefits.
A phase three trial involving 308 patients in the UK has found that a light-emitting mask conveys no “long-term therapeutic benefit” for those living with early diabetic macular edema.
But the chief executive of PolyPhotonix, the company that produces the mask, says the results are an indication of poor patient compliance rather than an ineffective device.
PolyPhotonix’s sleep mask delivers a precise dose of light therapy while the wearer is asleep. The company claims the treatment reduces and reverses the effects of diabetic retinopathy.
The findings of the randomized controlled trial, referred to as the CLEOPATRA study, are published in The Lancet Diabetes & Endocrinology.
The study was funded by the National Institute for Health Research, and involved 155 patients issued with a Noctura 400 Sleep Mask manufactured by PolyPhotonix Medical.
A further 153 patients received an ‘sham’ mask that does not emit light.
All the patients had non-central diabetic macular oedema and were advised to use the mask every night according to the instructions provided.
At the end of the two-year period, the researchers concluded that the study does not support the use of the device.