Clinical efficacy and safety of a light mask for prevention of dark adaptation in treating and preventing progression of early diabetic macular oedema at 24 months (CLEOPATRA): a multicentre, phase 3, randomised controlled trial
| Autor: | Randhir Chavan, S J Aldington, Arevik Ghulakhszian, Roxanne Crosby-Nwaobi, Richard D. Smith, Priya Prakash, Edward Hughes, Geoffrey B. Arden, Debendra N. Sahu, Sarah Walker, Alaistair Denniston, Jackie Sturt, Nirodhini Narendran, Nisha Shah, Abosede Cole, Sobha Sivaprasad, Haralabos Eleftheriadis, Joanna Kelly, Peter H Scanlon, Afsar Jafree, Sheena George, Tatiana Mansour, S Chave, A Dale, Tunde Peto, Namritha Patrao, A Toby Prevost, Ajay Bhatnagar, Joana C. Vasconcelos, Philip Hykin, Douglas Lewin, Gary S. Rubin, Chris Hogg, Caroline Murphy, Gilli Vafidis, Maria Sandinha, Frank Ahfat, Geeta Menon, David P. Crabb, Catherine A Egan, Gillian Hood, Joanathan Gibson, Graham A. Hitman, Ian Grierson, Helen Holmes, Deepthy Menon, Lauren Leitch-Devlin |
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| Přispěvatelé: | National Institute for Health Research |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
Endocrinology Diabetes and Metabolism THERAPY law.invention 0302 clinical medicine Endocrinology Randomized controlled trial law SCALE Sleep disorder Diabetic retinopathy Middle Aged INTENTION Editorial Treatment Outcome Disease Progression Female Life Sciences & Biomedicine Tomography Optical Coherence medicine.medical_specialty Dark Adaptation Minimisation (clinical trials) Article Macular Edema Retina 03 medical and health sciences Endocrinology & Metabolism SDG 3 - Good Health and Well-being Ophthalmology Internal Medicine medicine Journal Article Humans Adverse effect Macular edema CLEOPATRA Study Group Aged Science & Technology Diabetic Retinopathy business.industry Phototherapy medicine.disease Clinical trial Diabetic macular oedema 030221 ophthalmology & optometry RE business 030217 neurology & neurosurgery RC |
| Zdroj: | Sivaprasad, S, Vasconcelos, J C, Prevost, A T, Holmes, H, Hykin, P, George, S, Murphy, C, Kelly, J, Arden, G B, CLEOPATRA Study Group & Peto, T 2018, ' Clinical efficacy and safety of a light mask for prevention of dark adaptation in treating and preventing progression of early diabetic macular oedema at 24 months (CLEOPATRA): a multicentre, phase 3, randomised controlled trial ', The lancet. Diabetes & endocrinology . https://doi.org/10.1016/S2213-8587(18)30036-6 The Lancet. Diabetes & Endocrinology |
| ISSN: | 8559-6558 2213-8587 |
| DOI: | 10.1016/S2213-8587(18)30036-6 |
| Popis: | BACKGROUND: We aimed to assess 24-month outcomes of wearing an organic light-emitting sleep mask as an intervention to treat and prevent progression of non-central diabetic macular oedema.METHODS: CLEOPATRA was a phase 3, single-blind, parallel-group, randomised controlled trial undertaken at 15 ophthalmic centres in the UK. Adults with non-centre-involving diabetic macular oedema were randomly assigned (1:1) to wearing either a light mask during sleep (Noctura 400 Sleep Mask, PolyPhotonix Medical, Sedgefield, UK) or a sham (non-light) mask, for 24 months. Randomisation was by minimisation generated by a central web-based computer system. Outcome assessors were masked technicians and optometrists. The primary outcome was the change in maximum retinal thickness on optical coherence tomography (OCT) at 24 months, analysed using a linear mixed-effects model incorporating 4-monthly measurements and baseline adjustment. Analysis was done using the intention-to-treat principle in all randomised patients with OCT data. Safety was assessed in all patients. This trial is registered with Controlled-Trials.com, number ISRCTN85596558.FINDINGS: Between April 10, 2014, and June 15, 2015, 308 patients were randomly assigned to wearing the light mask (n=155) or a sham mask (n=153). 277 patients (144 assigned the light mask and 133 the sham mask) contributed to the mixed-effects model over time, including 246 patients with OCT data at 24 months. The change in maximum retinal thickness at 24 months did not differ between treatment groups (mean change -9·2 μm [SE 2·5] for the light mask vs -12·9 μm [SE 2·9] for the sham mask; adjusted mean difference -0·65 μm, 95% CI -6·90 to 5·59; p=0·84). Median compliance with wearing the light mask at 24 months was 19·5% (IQR 1·9-51·6). No serious adverse events were related to either mask. The most frequent adverse events related to the assigned treatment were discomfort on the eyes (14 with the light mask vs seven with the sham mask), painful, sticky, or watery eyes (14 vs six), and sleep disturbance (seven vs one).INTERPRETATION: The light mask as used in this study did not confer long-term therapeutic benefit on non-centre-involving diabetic macular oedema and the study does not support its use for this indication.FUNDING: The Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership. |
| Databáze: | OpenAIRE |
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