Noctura 400 Sleep Mask for diabetic retinopathy and diabetic macular oedema

The technology described in this briefing is Noctura 400 Sleep Mask. It is used for treating diabetic retinopathy (DR) and diabetic macular oedema (DMO).

The innovative aspects are that it is a non-invasive treatment that delivers light to the backs of the eyes while a person is sleeping or in a darkened room.

The intended place in therapy would be as an add-on treatment, alongside intravitreal injections of anti-vascular endothelial growth factor hormones or laser photocoagulation in people with late-stage DR or DMO, or as a preventative measure in people with early-stage DR.

The main points from the evidence summarised in this briefing are from 4 observational studies using different versions of the device (2 in the UK, 2 in Europe) including 151 adults in secondary care. They show that Noctura 400 Sleep Mask is a usable technology for people with DMO and mild to advanced non-proliferative DR, as well as early proliferative DR.

Key uncertainties around the evidence are that it is very limited in quantity and quality, with no randomised comparative studies assessing the effectiveness of Noctura 400 Sleep Mask compared with standard care. Cost-effectiveness studies are also needed.

The cost of Noctura 400 Sleep Mask is up to £1,250 per patient per year (excluding VAT). The overall resource impact is uncertain compared with standard care because of the lack of comparative evidence. There is no published evidence assessing the cost effectiveness of Noctura 400.