Real-world Evaluation of Noctura 400 sleep mask for DiabEtic Retinopathy (RENDER)

夜曲400睡眠面膜是一种新颖创新的治疗糖尿病视网膜病变和糖尿病黄斑水肿的方法，这是糖尿病的严重和危及视力的并发症。这种眼罩为治疗这些疾病提供了一种全新的方法，因为它在病人睡觉时向眼睛输送低强度的光。与目前的治疗方法相比，它是非侵入性的，为患者提供了更愉快的体验。目前的治疗方法需要将昂贵的药物直接注射到眼球中，或者使用激光烧灼视网膜上渗漏的血管。这种设备的成本是目前标准治疗费用的一小部分，NHS采用它将节省大量的药品费用，同时提高效率，减少等待和召回时间，并将改善临床结果，给患者更好的体验。夜曲400不仅可以治疗眼部疾病，还可以在早期阶段用于预防视网膜病变的发展，这将有利于患者的生活质量，并通过避免进展到医院环境和昂贵的临床治疗和程序的成本节省NHS的钱给患者。夜曲400已经完成了临床试验，并被批准作为一种医疗设备使用，但由于临床医生和管理人员需要更多的证据来证明其在现实世界中的成本效益，夜曲400还没有被NHS广泛采用。该项目的主要目标是跟踪在NHS环境下使用夜曲400睡眠面膜的患者，收集临床进展和财务影响数据，并以医院和CCG管理人员要求的形式分析结果，为NHS的广泛采用提出一个清晰而明确的案例。

The Noctura 400 Sleep Mask is a novel and innovative treatment for Diabetic Retinopathy and Diabetic Macular Oedema, which are the serious and sight threatening complications of Diabetes.The mask offers a completely new approach to treatment of these conditions as it delivers a low level of light into the eye while the patient sleeps. It is non-invasive and offers a more pleasant experience to patients compared to the current treatments which involve injecting a high cost drug directly into the eyeball or using lasers to cauterise leaky blood vessels in the retina.This device costs a fraction of the spend on the current standard treatments and its adoption by the NHS will save a large amount of money on the drugs bill, as well as increasing efficiencies, reducing waiting and recall times and will improve clinical outcomes and give patients a better experience.As well as treating eye disease, Noctura 400 can be used at an earlier stage to prevent retinopathy from developing and this would benefit both patient's quality of life as well as save the NHS money by avoiding progression to the hospital setting and the cost of the expensive clinical treatments and procedures given to patients today.Noctura 400 has completed clinical trials and has been approved for use as a medical device, however it has not been widely adopted in the NHS as clinicians and managers require more proof of its cost effectiveness in the real world.The key objective for this project is to follow patients using the Noctura 400 Sleep Mask in the NHS setting, collect both clinical progress and financial impact data and analyse the outcomes in the form required by hospital and CCG managers, presenting a clear and unequivocal case for widespread adoption in the NHS.