Evidence to Support the Claims made in the Patient Leaflet

Section: Discover Noctura 400

• The Noctura 400 sleep mask is an innovative technology which can be used as a therapy for Diabetic Retinopathy and Diabetic Macular Oedema

A preliminary trial to determine whether prevention of dark adaptation affects the course of  early diabetic retinopathy. Arden et al 2010 Eye 24; 1149-1155

Regression of early diabetic macular oedema is associated with prevention of dark adaptation.  Arden et al 2011 Eye 25; 1546-1554

CE Certificate – can be supplied on request

• The light therapy has been designed so that it doesn’t interfere with your sleep

The spectrum of light chosen for Noctura 400 is that which targets the peak absorption for the rod photoreceptors while minimising the effect on both cone receptors and also ipRGC (intrinsically photosensitive Retinal Ganglion Cells). The peak effect on circadian rhythm, from melanopsin absorption is at a shorter wavelength of 480nm – so sleep interference is minimised as much as possible.

Thomas J. Brennan et al. “Role of Melanopsin in Circadian Responses to Light”. Science vol 298 13th December 2002

Brainard, George C., et al. “Action spectrum for melatonin regulation in humans: evidence for a novel circadian photoreceptor.” The Journal of Neuroscience 21.16 (2001): 6405-6412.

Thapan KJA et al. An action spectrum for melatonin suppression: evidence for a novel non‐rod, non‐cone photoreceptor system in humans.

Section: How Noctura 400 works

• When you have diabetes high blood glucose levels and circulation problems can cause changes to the blood vessels in your eyes and lead to Diabetic Retinopathy
• (Cycle of hypoxia diagram)

Rods, Dark Adaptation, and the Development of Diabetic Retinopathy. David J. Ramsey et al 2015 Enliven: Clinical Ophthalmology Research.

Li, Fu, and Lo (2012) Hypoxia – induced oxidative stress in ischemic retinopathy. Ox Med cell Long id 426769 1-10

Shortt et al (2004) Chronic systemic hypoxia causes intra-retinal angiogenesis. Journal of Anatomy 205; 349-358

Argaman and Nikinmaa (2006) oxygen dependent diseases in the retina: role of hypoxia inducible factors. Exp Eye Res 2006 Sep;83(3):473-83. Epub 2006 Jun 5.

Section: About Diabetic Retinopathy

• (Pictures illustrating vision with advanced DR)

The originals are from the National Eye Institute https://nei.nih.gov/health/diabetic/retinopathy and are in the public domain widely used all over the internet by eye clinics and Wikipedia https://en.wikipedia.org/wiki/Diabetic_retinopathy

The image is hosted here:  https://www.flickr.com/photos/nationaleyeinstitute/7544734198/in/photostream/ and is subject to a basic Creative Commons licence: https://creativecommons.org/licenses/by/2.0/

• Possible Symptoms

Listed in various formats – examples include

Diabetes.co.uk http://www.diabetes.co.uk/diabetes-complications/diabetic-retinopathy.html

Mayo Clinic http://www.mayoclinic.org/diseases-conditions/diabetic-retinopathy/basics/symptoms/con-20023311

Macular Society Guide to DMO – to be supplied

• Diabetic Retinopathy and Diabetic Macular Oedema are serious complications of diabetes and are the most common causes of blindness among people of working age in the UK

DiabetesUK https://www.diabetes.org.uk/Retinopathy