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Kit that’s coming soon: Noctura 400 Eyemask for diabetic retinopathy and oedema

POLYPHOTONIX

One of the ‘complications’ of living with diabetes is the prospect of a diagnosis of Diabetic Retinopathy. A relatively new product may be able to reduce the impact of this progressive disorder, preventing or at least delaying the potential outcome of blindness from this condition.

The eye is unique in terms of being a body organ that has pressure inside them as well as a not very flexible exterior. In the eye, there are rods and cones. The rods operate in dim lighting conditions and are not active in daylight. They basically wake up when the sun goes down.

In order to work, rods need energy and oxygen. One of the impacts of diabetes is that all internal membranes thicken, meaning that in the eye some capillaries may struggle to deliver the necessary oxygen in the blood to the tissues that need it. If rods don’t get enough oxygen or energy they tend to ‘steal it from next door’, which is why new, local capillaries tend to grow in order to solve the problem. It’s actually a stress response but the problem with the newly grown capillaries is that they tend to be weak. They are prone to rupture, with blood then entering the gel in the eye (the vitreous humour), obscuring vision.

A direct link has been proven that is the rods that are involved in causing diabetic retinopathy, and that it is happening when you sleep when there is little or no light. That is when rods get busy and the need for oxygen goes up.

Based on this, PolyPhotonix, a British-based medical company has developed an eyemask for use at nighttime and which mitigates against this effect. By using the appropriate lightwave, the mask keeps the rods happy while not letting them demand too much oxygen, thereby preventing the development of the newer, local capillaries.

This treatment is easy to do it can be done at home. The amount of light used in the mask is very weak, too weak to actually disrupt your circadian levels, i.e. there would be no reason why your sleep hormone production would be affected. You should sleep fine.

Well developed

There has already been several years of development of the Noctura 400 eyemask. With regards any medical device, a Phase 1 trial is done to prove that no harm is being done by using the treatment. The Noctura 400 eyemask has passed a Phase 1 trial. Then a Phase 2 trial is done to prove that the treatment works.

Noctura Eye Mask

MAN WITH THE MASK: Quality technician Neil Martin with the Noctura 400. Picture: STUART BOULTON.

Moira Hopkins has been involved in the project since 2013. She has a background in physics and has been primarily working on launching the product in the UKthe company is based in Sedgefield County Durham. She says, “Unfortunately, within 20 years of diagnosis nearly everyone with Type 1 diabetes and almost 2/3 of people with Type 2 diabetes will have some degree of retinopathy*. However patients are only treated at relatively late stages of developing the condition. The retina has huge oxygen consumption, the highest oxygen requirement of any tissue in the body, because of the high metabolic rate of the photo-receptors (rods and cones) and other structures. You have approximately 120 million rods which operate in the dark, and 7million cones that operate in the light. Rods continue to operate even when you’re asleep, which means they are still using oxygen. This leads to an increased demand for blood supply in the eye. Retinal hypoxia is the medical term for a lack of oxygen. In those circumstances body then creates extra blood vessels to supply demand.

“The Noctura 400 eyemask works by providing a very low intensity of light of the specific wavelength. This prevents the rods from dark-adapting. It’s a specific wavelength that will not disrupt sleep. Our phase 2 trial showed that retinopathy cysts were either reduced in size or gone after six months we could show that treated eyes got better while untreated eyes got worse.”

The device is programmed to suit each patient’s normal hours of sleep.It should be worn every night for as long as they are in bed up to a maximum of eight hours and it lasts for three months, then it gets replaced. The previous mask is returned to the company who can then see how much it is being used. By compiling the data on patients and linking it to eye health, the company is proving that the product is effective and a potential sight-saver. The point of returning the used mask to the clinician who can assess how it is being used is also partly to help support the user to make the best use of it. The eyemask can be set up so that data from it can be downloaded to a secure server and can be shared with the clinician or caregiver to monitor use.

The Noctura eyemask 400 is a treatment for life; you can take a break and skip a night if you need to, but otherwise it should be used every night. It’s a Class IIa medical device with CE accreditation and the use of it is monitored by a health professional.

Health economics

At the moment there are only two treatments available for retinopathy. The first is laser, which is invasive and causes permanent damage in itself. The second is intravitreous injections of the drug Lucentis, which costs approximately £6k per year per eye and requires monthly hospital visits for the injections. This tends to be recommended in the presence of diabetic retinal oedema. It is estimated that something like £260million is spent by the NHS on injections to treat the effects of retinopathy, while the cost of laser treatment has not been clearly quantified.

The Noctura 400 eyemask costs £250 per three months and treats both eyes. So that’s £1000 per year, or £500 per eye. That represents potentially huge cost savings, especially if the eyemasks are introduced early as a preventative treatment.

The mask has also been shown to work to reduce the presence of diabetic macular oedema.

Says Hopkins, “This eyemask is much more cost-effective than current treatments and of course aims at preserving sight, therefore saving much distress as well.”

ACCESS TO NOCTURA EYEMASKS

Although this feature is called Kit That’s Coming Soon, that tends to refer to whether or not this device will ever be available on the NHS. At the moment that is not the case with the Nocture 400 eyemask, however it is available privately, not directly from PolyPhotonix but through a number of independent opticians including a home-visiting opthalmology service The Outside Clinic.

One of The Outside Clinic’s qualified staff visits your home to talk through the product, check your eyesight before you go on the eyemask, then reassess your eye health every three or six months while using the product, the aim of which is to reduce the progression of retinopathy. In this way you should be able to track the progress and effectiveness of the eyemask on your eye health.

The Noctura products while currently being developed specifically to treat diabetic retinopathy is also being considered for use for age-related macular degeneration and also dry age-related macular degeneration.

*SOURCE: Diabetes UK

CONTACT: www.noctura.com or call the Noctura Advisory Line on 01740 669143. Please mention Desang when making contact about the eyemask.

News items and features like this appear in the Desang Diabetes Magazine, our free-to-receive digital journal (see below). We cover diabetes news, diabetes management equipment (diabetes ‘kit’ such as insulin pumps and continuous glucose monitoring equipment) and news about food suitable for a diabetic diet including a regular Making Carbs Count column. We just need your email address to subscribe you (it’s free, and you can easily unsubscribe should you wish to).

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