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

• Published in: The lancet. Diabetes & endocrinology Vol. 6; no. 5; pp. 382 - 391
• Main Authors: Sivaprasad, Sobha, Vasconcelos, Joana C, Prevost, A Toby, Holmes, Helen, Hykin, Philip, George, Sheena, Murphy, Caroline, Kelly, Joanna, Arden, Geoffrey B, Ahfat, Frank, Bhatnagar, Ajay, Narendran, Nirodhini, Chavan, Randhir, Cole, Abosede, Crosby-Nwaobi, Roxanne, Patrao, Namritha, Menon, Deepthy, Hogg, Chris, Rubin, Gary, Leitch-Devlin, Lauren, Egan, Catherine, Shah, Nisha, Mansour, Tatiana, Peto, Tunde, Eleftheriadis, Haralabos, Gibson, Joanathan, Ghulakhszian, Arevik, Vafidis, Gilli, Hughes, Edward, Jafree, Afsar, Menon, Geeta, Prakash, Priya, Sandinha, Maria, Smith, Richard, Scanlon, Peter, Chave, Steve, Aldington, Steve, Dale, Angela, Hood, Gillian, Hitman, Graham A, Crabb, David, Denniston, Alaistair, Lewin, Douglas, Grierson, Ian, Walker, Sarah, Sturt, Jackie, Sahu, Debendra
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.05.2018; The Lancet, Diabetes & Endocrinology
• Subjects: Aged; Dark Adaptation; Diabetic Retinopathy - complications; Disease Progression; Female; Humans; Macular Edema - complications; Macular Edema - diagnostic imaging; Macular Edema - prevention & control; Male; Middle Aged; Phototherapy - instrumentation; Phototherapy - methods; Retina - diagnostic imaging; Retina - pathology; Tomography, Optical Coherence; Treatment Outcome

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. CLEOPATRA was a phase 3, single-blind, parallel-group, randomised controlled trial undertaken at 15 ophthalmic centres in t...