Optometrists and ophthalmologists will soon be able to equip patients who have diabetes with a non-invasive, home-based device that has been shown, across 2.5 million recorded hours of patient treatment, to improve and stabilise progression of diabetic eye disease.
The device can help to reduce advancement to later stage interventions such as intravitreal anti-VEGF injections into the eye, and mitigate the associated treatment and capacity burden this can place on the patient and healthcare system alike.
The Noctura 400 Sleep Mask, developed in the United Kingdom by PolyPhotonix Medical, carries CE certification and has been listed on the United Kingdom’s National Health Service drug tariff – meaning it is prescribed to patients free of charge. At the time of going to print, Therapeutic Goods Administration (TGA) approval was anticipated for distribution in Australia.
Martin Holland, Operations Director at PolyPhotonix, explained that the mask treats retinopathy by addressing retinal hypoxia.
“The human eye has the greatest oxygen demand of any tissue in the body. That’s due to the metabolic rate of the photoreceptors; the rods and cones,” Mr Holland said. “When we go to sleep at night, we go through a process of dark adaptation where we gain night vision, and our 120 million rod photoreceptors require a huge amount of oxygen. In the diabetic eye, where there’s a compromised blood flow, that oxygen demand can’t be delivered. So that leads to hypoxia in the inner retina, and that drives the upregulation of VEGF (vascular endothelial growth factor). VEGF grows new vessels, which are fragile, and they leak, and that’s retinopathy.”
The light basically says, ‘calm down, you don’t need that oxygen, it’s daytime’.
Green Light Stimulates Rods
The device emits a low-level green light, tuned to the peak response of the rod photoreceptor, through the closed eyelid during sleep. By maintaining a low level of rod stimulation overnight, it reduces the metabolic oxygen demand associated with dark adaptation.
“The light basically says, ‘calm down, you don’t need that oxygen, it’s daytime’. So it’s tricking the eye effectively,” Mr Holland said. “We stop the hypoxia, we stop the upregulation of VEGF, and we prevent the growth of new vessels.”
However, Mr Holland said the mask does not resolve existing neovascularisation, and proliferative patients still require treatment, though the device may be used as an adjunct. “Noctura won’t deal with vessels that are already there,” he said. “But where it’s very successful is treating patients earlier in the pathway.”
The wavelength selection is central to the device’s tolerability. The green light is matched to the rod response and does not stimulate the cones, which Mr Holland said is necessary for an undisturbed sleep. The company reports that melatonin levels are not affected, and that patients habituate to the light within roughly 15 minutes via the Troxler effect, in which the brain disregards a constant stimulus.
Capacitive sensors, built into the mask, record the user’s wearing frequency, providing compliance data that is correlated against optical coherence tomography, fundus imaging, and visual acuity. At present, the mask is prescribed, supplied, and returned by post to PolyPhotonix every three months, where the data is downloaded and passed on to the patient’s eye specialist. The next iteration of the device will transmit data directly to the eye specialist via Bluetooth.
Clinical Evidence Led to NHS Listing
The clinical case for Noctura 400 rests on a body of published small studies, pending publications, and real-world evidence rather than a large randomised controlled trial, a point Mr Holland addressed directly. “We are not a drug, and therefore we don’t have the same level of data as a drug,” he said. “But what we do have is a lot of real-world data and seven trials conducted across multiple NHS (National Health Service) Hospitals, Royal Oman Police Hospital, and other locations.1-6
Among the supporting data is the RENDER evaluation,1 conducted in an NHS hospital across the COVID-19 period, in which patients on three-month recall were offered the mask before hospital eye services closed in response to the pandemic. “Ninety-six per cent of the patients (who completed the study) demonstrated positive outcomes. None of the patients progressed to intravitreal injections,” Mr Holland said, adding that nearly six years on, 92% positive clinical outcomes were being maintained, with data due to be published.
That evidence base underpinned the device’s listing on the NHS drug tariff in England and Wales, with separate listings for Scotland and Northern Ireland, making Noctura the only such device available on prescription, free of charge, to patients in the UK.
Positive Health Economics
The health-economic argument is likely to resonate locally. Mr Holland noted that one year of treatment costs less than a single intravitreal anti-VEGF injection, against a typical first-year burden of up to eight injections for diabetic retinopathy, which represents a substantial cost to health systems. Of the 1.5 million people in Australia diagnosed with diabetes, between 25–35% of people have some degree of diabetic retinopathy.7 Among them, an estimated 91,000 are living with diabetic macular oedema, requiring treatment with intravitreal anti-VEGF injection.7
As well as saving money for the health system, delaying disease progression by proactively treating with the mask could significantly reduce the burden of treatment for patients, many of whom are at working age. Mr Holland said patients with diabetic eye disease, contraindicated for intravitreal anti-VEGF injection, including those who have had a cardiac or stroke event, are on dialysis, or are pregnant, as well as those who are simply fearful of injections, are also appropriate candidates.
Once approved by the TGA, the Noctura 400 mask will be distributed to ophthalmologists and optometrists in Australia and New Zealand by Good Optical Services. mivision will host a webinar on Noctura 400, sponsored by Good Optical Services at 6.30pm on Tuesday 25 August. Visit: bit.ly/4eN8i9S.
References
- Meyer-Bothling U, Meyer-Bothling O, Pinney M. A real-world single-centre study of patients with diabetic macular oedema who wore a home-use sleep mask (Noctura 400) for one year. J Ophthalmol. 2021 Jun 15;2021:6612126. doi: 10.1155/2021/6612126.
- Farrar AL, Hill D, Meyer-Bothling O, et al. Home-use sleep mask (Noctura 400) wear before and during the COVID-19 pandemic with its associated lockdowns in England. J Opto Ophth. 2022; 3(1):1-14. doi: 10.37191/Mapsci-JOO-3(1)-023.
- Sahni JN, Czanner, Gutu T et al. Safety and acceptability of an organic light-emitting diode sleep mask as a potential therapy for retinal disease. Eye (Lond). 2017; 31: 97-106.
- Arden GB, Jyothi S, Sivaprasad S, et al. Regression of early diabetic macular oedema is associated with prevention of dark adaptation. Eye (Lond). 2011 Dec;25(12):1546-54. doi: 10.1038/eye.2011.264.
- Kuchynka P, Grierson I, Hill D, et al. Patients with diabetic eye disease using a potentially therapeutic mask. Do sufficient patients wear the mask and for how long?. Adv Ophthalmol Vis Syst (2017) 7(7): 00253. doi: 10.15406/aovs.2017.07.00253.
- Arden GB, Gündüz MK, Okudan S, et al. A preliminary trial to determine whether prevention of dark adaptation affects the course of early diabetic retinopathy. Eye (Lond). 2010 Jul;24(7):1149-55. doi: 10.1038/eye.2009.328.
- Macular Disease Foundation Australia. New service supports people living with diabetes-related eye conditions. Available at: mdfoundation.com.au/news/new-service-supports-people-living-with-diabetes-related-eye-conditions [accessed Jun 2026].
