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

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...

Full description

Saved in:
Bibliographic Details
Published inThe 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
LanguageEnglish
Published England Elsevier Ltd 01.05.2018
The Lancet, Diabetes & Endocrinology
Subjects
Online AccessGet full text

Cover

Loading…
Abstract 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 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. 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). 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. The Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.
AbstractList 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 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. 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). 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. The Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.
BACKGROUNDWe 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.METHODSCLEOPATRA 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.FINDINGSBetween 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).INTERPRETATIONThe 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.FUNDINGThe Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.
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 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. 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). 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. The Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.
Author Bhatnagar, Ajay
Menon, Geeta
Grierson, Ian
Hogg, Chris
Crabb, David
Patrao, Namritha
Murphy, Caroline
Hykin, Philip
Hitman, Graham A
Sivaprasad, Sobha
Gibson, Joanathan
Sandinha, Maria
Leitch-Devlin, Lauren
Holmes, Helen
Prakash, Priya
Walker, Sarah
Sturt, Jackie
Dale, Angela
George, Sheena
Narendran, Nirodhini
Chavan, Randhir
Smith, Richard
Lewin, Douglas
Vafidis, Gilli
Prevost, A Toby
Denniston, Alaistair
Jafree, Afsar
Eleftheriadis, Haralabos
Hughes, Edward
Chave, Steve
Aldington, Steve
Hood, Gillian
Kelly, Joanna
Vasconcelos, Joana C
Shah, Nisha
Ghulakhszian, Arevik
Peto, Tunde
Mansour, Tatiana
Menon, Deepthy
Crosby-Nwaobi, Roxanne
Ahfat, Frank
Sahu, Debendra
Cole, Abosede
Rubin, Gary
Arden, Geoffrey B
Egan, Catherine
Scanlon, Peter
AuthorAffiliation a National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, UK
b Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK
e Institute of Ophthalmology and Moorfields Eye Hospital, London, UK
c King's Clinical Trials Unit at King's Health Partners, King's College London, London, UK
d Hillingdon Hospital, Hillingdon Hospitals National Health Service Foundation Trust, Uxbridge, UK
AuthorAffiliation_xml – name: e Institute of Ophthalmology and Moorfields Eye Hospital, London, UK
– name: b Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK
– name: a National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, UK
– name: c King's Clinical Trials Unit at King's Health Partners, King's College London, London, UK
– name: d Hillingdon Hospital, Hillingdon Hospitals National Health Service Foundation Trust, Uxbridge, UK
Author_xml – sequence: 1
  givenname: Sobha
  surname: Sivaprasad
  fullname: Sivaprasad, Sobha
  email: sobha.sivaprasad@moorfields.nhs.uk
  organization: National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, UK
– sequence: 2
  givenname: Joana C
  surname: Vasconcelos
  fullname: Vasconcelos, Joana C
  organization: Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK
– sequence: 3
  givenname: A Toby
  surname: Prevost
  fullname: Prevost, A Toby
  organization: Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK
– sequence: 4
  givenname: Helen
  surname: Holmes
  fullname: Holmes, Helen
  organization: King's Clinical Trials Unit at King's Health Partners, King's College London, London, UK
– sequence: 5
  givenname: Philip
  surname: Hykin
  fullname: Hykin, Philip
  organization: National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, UK
– sequence: 6
  givenname: Sheena
  surname: George
  fullname: George, Sheena
  organization: Hillingdon Hospital, Hillingdon Hospitals National Health Service Foundation Trust, Uxbridge, UK
– sequence: 7
  givenname: Caroline
  surname: Murphy
  fullname: Murphy, Caroline
  organization: King's Clinical Trials Unit at King's Health Partners, King's College London, London, UK
– sequence: 8
  givenname: Joanna
  surname: Kelly
  fullname: Kelly, Joanna
  organization: King's Clinical Trials Unit at King's Health Partners, King's College London, London, UK
– sequence: 9
  givenname: Geoffrey B
  surname: Arden
  fullname: Arden, Geoffrey B
  organization: Institute of Ophthalmology and Moorfields Eye Hospital, London, UK
– sequence: 10
  givenname: Frank
  surname: Ahfat
  fullname: Ahfat, Frank
– sequence: 11
  givenname: Ajay
  surname: Bhatnagar
  fullname: Bhatnagar, Ajay
– sequence: 12
  givenname: Nirodhini
  surname: Narendran
  fullname: Narendran, Nirodhini
– sequence: 13
  givenname: Randhir
  surname: Chavan
  fullname: Chavan, Randhir
– sequence: 14
  givenname: Abosede
  surname: Cole
  fullname: Cole, Abosede
– sequence: 15
  givenname: Roxanne
  surname: Crosby-Nwaobi
  fullname: Crosby-Nwaobi, Roxanne
– sequence: 16
  givenname: Namritha
  surname: Patrao
  fullname: Patrao, Namritha
– sequence: 17
  givenname: Deepthy
  surname: Menon
  fullname: Menon, Deepthy
– sequence: 18
  givenname: Chris
  surname: Hogg
  fullname: Hogg, Chris
– sequence: 19
  givenname: Gary
  surname: Rubin
  fullname: Rubin, Gary
– sequence: 20
  givenname: Lauren
  surname: Leitch-Devlin
  fullname: Leitch-Devlin, Lauren
– sequence: 21
  givenname: Catherine
  surname: Egan
  fullname: Egan, Catherine
– sequence: 22
  givenname: Nisha
  surname: Shah
  fullname: Shah, Nisha
– sequence: 23
  givenname: Tatiana
  surname: Mansour
  fullname: Mansour, Tatiana
– sequence: 24
  givenname: Tunde
  surname: Peto
  fullname: Peto, Tunde
– sequence: 25
  givenname: Haralabos
  surname: Eleftheriadis
  fullname: Eleftheriadis, Haralabos
– sequence: 26
  givenname: Joanathan
  surname: Gibson
  fullname: Gibson, Joanathan
– sequence: 27
  givenname: Arevik
  surname: Ghulakhszian
  fullname: Ghulakhszian, Arevik
– sequence: 28
  givenname: Gilli
  surname: Vafidis
  fullname: Vafidis, Gilli
– sequence: 29
  givenname: Edward
  surname: Hughes
  fullname: Hughes, Edward
– sequence: 30
  givenname: Afsar
  surname: Jafree
  fullname: Jafree, Afsar
– sequence: 31
  givenname: Geeta
  surname: Menon
  fullname: Menon, Geeta
– sequence: 32
  givenname: Priya
  surname: Prakash
  fullname: Prakash, Priya
– sequence: 33
  givenname: Maria
  surname: Sandinha
  fullname: Sandinha, Maria
– sequence: 34
  givenname: Richard
  surname: Smith
  fullname: Smith, Richard
– sequence: 35
  givenname: Peter
  surname: Scanlon
  fullname: Scanlon, Peter
– sequence: 36
  givenname: Steve
  surname: Chave
  fullname: Chave, Steve
– sequence: 37
  givenname: Steve
  surname: Aldington
  fullname: Aldington, Steve
– sequence: 38
  givenname: Angela
  surname: Dale
  fullname: Dale, Angela
– sequence: 39
  givenname: Gillian
  surname: Hood
  fullname: Hood, Gillian
– sequence: 40
  givenname: Graham A
  surname: Hitman
  fullname: Hitman, Graham A
– sequence: 41
  givenname: David
  surname: Crabb
  fullname: Crabb, David
– sequence: 42
  givenname: Alaistair
  surname: Denniston
  fullname: Denniston, Alaistair
– sequence: 43
  givenname: Douglas
  surname: Lewin
  fullname: Lewin, Douglas
– sequence: 44
  givenname: Ian
  surname: Grierson
  fullname: Grierson, Ian
– sequence: 45
  givenname: Sarah
  surname: Walker
  fullname: Walker, Sarah
– sequence: 46
  givenname: Jackie
  surname: Sturt
  fullname: Sturt, Jackie
– sequence: 47
  givenname: Debendra
  surname: Sahu
  fullname: Sahu, Debendra
BackLink https://www.ncbi.nlm.nih.gov/pubmed/29519744$$D View this record in MEDLINE/PubMed
BookMark eNqFUstuUzEQvUJFtJR-AsjLVGrA9n35sgBFUXlIkYoge2tiz01Mfe1gO5Hyv3wIzqMRrFjNeObMmePReVlcOO-wKF4z-pZR1rz7wTkrx6IW7YiJ25LSshk3z4qrU7mrL865aC-Lmxh_UkoZrctG0BfFJe9q1rVVdVX8nlrjjAJLsO9zVDsCTpMIPaYd8T0BYs1ylcgA8ZH0PpB1wC26ZLzbtzWERwIa1gkOJeNICphztzwQPaHzcx38MmCMp0mEYHdEG1hgMirzq42FQDxqHIBAIrwig3dpFcloOrt_-DaZf5_cvs-Cho3NE5k14B1ZryAiKe9IyOv8YCJqovJY8NbmNAUD9lXxvAcb8eYUr4v5p_v59Mt49vD563QyG6uqadMYK4FtW2pOFyWIClU-NWt6aHVXdy2FTjWCa1ZxtWhpXy84gxb6qudYV3XdlNfFhyPterMYUB8UgpXrYAYIO-nByH87zqzk0m9l3VHRCp4JRieC4H9tMCaZ_6PQWnDoN1FyynjHRFXuofURqoKPMWB_XsOo3HtEHjwi9waQTMiDR-Re45u_NZ6nnhyRAR-PAMyH2hoMMiqDTqE2AVWS2pv_rPgDRmPR8w
CitedBy_id crossref_primary_10_1109_ACCESS_2020_3015258
crossref_primary_10_1167_iovs_18_26297
crossref_primary_10_4103_IJO_IJO_2182_22
crossref_primary_10_15252_emmm_201910473
crossref_primary_10_3310_eme06020
crossref_primary_10_1016_j_clae_2021_02_007
crossref_primary_10_1167_iovs_18_26433
crossref_primary_10_1016_j_nbd_2020_104754
crossref_primary_10_1016_j_ajpath_2023_09_004
crossref_primary_10_1016_j_ygeno_2021_10_010
crossref_primary_10_1016_S2213_8587_18_30068_8
crossref_primary_10_1007_s00417_023_06272_1
crossref_primary_10_1007_s11892_019_1218_2
crossref_primary_10_1097_IAE_0000000000003424
crossref_primary_10_1017_S0952523820000036
crossref_primary_10_1016_j_aopr_2022_100051
crossref_primary_10_1017_S0952523820000097
crossref_primary_10_1097_OPX_0000000000001691
crossref_primary_10_1017_S0952523820000061
crossref_primary_10_1038_s41433_018_0251_8
Cites_doi 10.1038/eye.2009.328
10.1002/sim.1981
10.1192/bjp.183.4.323
10.1085/jgp.88.4.521
10.1038/eye.2015.254
10.1177/1740774512450098
10.1167/iovs.16-19415
10.1167/iovs.03-0557
10.1056/NEJMra050100
10.1038/eye.2016.259
10.1001/archopht.1985.01050120030015
10.1093/sleep/14.6.540
10.1177/009286150804200402
10.1007/s00125-017-4381-5
10.1097/IAE.0000000000000403
10.1186/1745-6215-15-458
10.1001/archopht.125.3.318
10.1136/bmj.d40
10.1038/eye.2011.264
10.1016/S2213-8587(16)30052-3
ContentType Journal Article
Contributor Bhatnagar, Ajay
Menon, Geeta
Grierson, Ian
Hogg, Chris
Crabb, David
Patrao, Namritha
Hitman, Graham A
Gibson, Joanathan
Sandinha, Maria
Leitch-Devlin, Lauren
Prakash, Priya
Walker, Sarah
Sturt, Jackie
Dale, Angela
Narendran, Nirodhini
Chavan, Randhir
Smith, Richard
Lewin, Douglas
Vafidis, Gilli
Denniston, Alaistair
Jafree, Afsar
Eleftheriadis, Haralabos
Hughes, Edward
Chave, Steve
Aldington, Steve
Hood, Gillian
Shah, Nisha
Ghulakhszian, Arevik
Peto, Tunde
Mansour, Tatiana
Menon, Deepthy
Crosby-Nwaobi, Roxanne
Ahfat, Frank
Sahu, Debendra
Cole, Abosede
Rubin, Gary
Egan, Catherine
Scanlon, Peter
Contributor_xml – sequence: 1
  givenname: Frank
  surname: Ahfat
  fullname: Ahfat, Frank
– sequence: 2
  givenname: Ajay
  surname: Bhatnagar
  fullname: Bhatnagar, Ajay
– sequence: 3
  givenname: Nirodhini
  surname: Narendran
  fullname: Narendran, Nirodhini
– sequence: 4
  givenname: Randhir
  surname: Chavan
  fullname: Chavan, Randhir
– sequence: 5
  givenname: Abosede
  surname: Cole
  fullname: Cole, Abosede
– sequence: 6
  givenname: Roxanne
  surname: Crosby-Nwaobi
  fullname: Crosby-Nwaobi, Roxanne
– sequence: 7
  givenname: Namritha
  surname: Patrao
  fullname: Patrao, Namritha
– sequence: 8
  givenname: Deepthy
  surname: Menon
  fullname: Menon, Deepthy
– sequence: 9
  givenname: Chris
  surname: Hogg
  fullname: Hogg, Chris
– sequence: 10
  givenname: Gary
  surname: Rubin
  fullname: Rubin, Gary
– sequence: 11
  givenname: Lauren
  surname: Leitch-Devlin
  fullname: Leitch-Devlin, Lauren
– sequence: 12
  givenname: Catherine
  surname: Egan
  fullname: Egan, Catherine
– sequence: 13
  givenname: Nisha
  surname: Shah
  fullname: Shah, Nisha
– sequence: 14
  givenname: Tatiana
  surname: Mansour
  fullname: Mansour, Tatiana
– sequence: 15
  givenname: Tunde
  surname: Peto
  fullname: Peto, Tunde
– sequence: 16
  givenname: Haralabos
  surname: Eleftheriadis
  fullname: Eleftheriadis, Haralabos
– sequence: 17
  givenname: Joanathan
  surname: Gibson
  fullname: Gibson, Joanathan
– sequence: 18
  givenname: Arevik
  surname: Ghulakhszian
  fullname: Ghulakhszian, Arevik
– sequence: 19
  givenname: Gilli
  surname: Vafidis
  fullname: Vafidis, Gilli
– sequence: 20
  givenname: Edward
  surname: Hughes
  fullname: Hughes, Edward
– sequence: 21
  givenname: Afsar
  surname: Jafree
  fullname: Jafree, Afsar
– sequence: 22
  givenname: Geeta
  surname: Menon
  fullname: Menon, Geeta
– sequence: 23
  givenname: Priya
  surname: Prakash
  fullname: Prakash, Priya
– sequence: 24
  givenname: Maria
  surname: Sandinha
  fullname: Sandinha, Maria
– sequence: 25
  givenname: Richard
  surname: Smith
  fullname: Smith, Richard
– sequence: 26
  givenname: Peter
  surname: Scanlon
  fullname: Scanlon, Peter
– sequence: 27
  givenname: Steve
  surname: Chave
  fullname: Chave, Steve
– sequence: 28
  givenname: Steve
  surname: Aldington
  fullname: Aldington, Steve
– sequence: 29
  givenname: Angela
  surname: Dale
  fullname: Dale, Angela
– sequence: 30
  givenname: Gillian
  surname: Hood
  fullname: Hood, Gillian
– sequence: 31
  givenname: Graham A
  surname: Hitman
  fullname: Hitman, Graham A
– sequence: 32
  givenname: David
  surname: Crabb
  fullname: Crabb, David
– sequence: 33
  givenname: Alaistair
  surname: Denniston
  fullname: Denniston, Alaistair
– sequence: 34
  givenname: Douglas
  surname: Lewin
  fullname: Lewin, Douglas
– sequence: 35
  givenname: Ian
  surname: Grierson
  fullname: Grierson, Ian
– sequence: 36
  givenname: Sarah
  surname: Walker
  fullname: Walker, Sarah
– sequence: 37
  givenname: Jackie
  surname: Sturt
  fullname: Sturt, Jackie
– sequence: 38
  givenname: Debendra
  surname: Sahu
  fullname: Sahu, Debendra
Copyright 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.
2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license 2018
Copyright_xml – notice: 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
– notice: Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.
– notice: 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license 2018
CorporateAuthor CLEOPATRA Study Group
CorporateAuthor_xml – name: CLEOPATRA Study Group
DBID 6I.
AAFTH
CGR
CUY
CVF
ECM
EIF
NPM
AAYXX
CITATION
7X8
5PM
DOI 10.1016/S2213-8587(18)30036-6
DatabaseName ScienceDirect Open Access Titles
Elsevier:ScienceDirect:Open Access
Medline
MEDLINE
MEDLINE (Ovid)
MEDLINE
MEDLINE
PubMed
CrossRef
MEDLINE - Academic
PubMed Central (Full Participant titles)
DatabaseTitle MEDLINE
Medline Complete
MEDLINE with Full Text
PubMed
MEDLINE (Ovid)
CrossRef
MEDLINE - Academic
DatabaseTitleList
MEDLINE - Academic
MEDLINE
Database_xml – sequence: 1
  dbid: NPM
  name: PubMed
  url: https://proxy.k.utb.cz/login?url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed
  sourceTypes: Index Database
– sequence: 2
  dbid: EIF
  name: MEDLINE
  url: https://proxy.k.utb.cz/login?url=https://www.webofscience.com/wos/medline/basic-search
  sourceTypes: Index Database
DeliveryMethod fulltext_linktorsrc
Discipline Medicine
EISSN 2213-8595
EndPage 391
ExternalDocumentID 10_1016_S2213_8587_18_30036_6
29519744
S2213858718300366
Genre Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Journal Article
GrantInformation The Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.
GrantInformation_xml – fundername: Medical Research Council
GroupedDBID -RU
.1-
.FO
0R~
1P~
4.4
457
53G
6I.
AAEDT
AAEDW
AAFTH
AALRI
AAQQT
AAXUO
ABUDA
ACGFS
ADBBV
AENEX
AFRHN
AFTJW
AITUG
AJUYK
ALMA_UNASSIGNED_HOLDINGS
AMRAJ
EBS
EJD
FDB
GBLVA
HZ~
O9-
OB0
ON-
ROL
Z5R
ZA5
AAMRU
AAQFI
CGR
CUY
CVF
ECM
EIF
NPM
AAYXX
CITATION
7X8
5PM
ID FETCH-LOGICAL-c467t-e48e773d20b3a84ec01616fa7d95970a9c682d142cb70f5b21a7af4f2e545563
ISSN 2213-8587
IngestDate Tue Sep 17 21:24:03 EDT 2024
Fri Oct 25 00:41:13 EDT 2024
Thu Sep 26 19:34:25 EDT 2024
Wed Oct 16 00:49:11 EDT 2024
Tue May 16 22:26:13 EDT 2023
IsDoiOpenAccess true
IsOpenAccess true
IsPeerReviewed true
IsScholarly true
Issue 5
Language English
License This is an open access article under the CC BY license.
Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.
This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
LinkModel OpenURL
MergedId FETCHMERGED-LOGICAL-c467t-e48e773d20b3a84ec01616fa7d95970a9c682d142cb70f5b21a7af4f2e545563
Notes ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
ObjectType-News-3
content type line 23
Study group members listed at end of report
OpenAccessLink https://pubmed.ncbi.nlm.nih.gov/PMC5908782
PMID 29519744
PQID 2012918432
PQPubID 23479
PageCount 10
ParticipantIDs pubmedcentral_primary_oai_pubmedcentral_nih_gov_5908782
proquest_miscellaneous_2012918432
crossref_primary_10_1016_S2213_8587_18_30036_6
pubmed_primary_29519744
elsevier_sciencedirect_doi_10_1016_S2213_8587_18_30036_6
PublicationCentury 2000
PublicationDate May 2018
2018-05-00
20180501
PublicationDateYYYYMMDD 2018-05-01
PublicationDate_xml – month: 05
  year: 2018
  text: May 2018
PublicationDecade 2010
PublicationPlace England
PublicationPlace_xml – name: England
PublicationTitle The lancet. Diabetes & endocrinology
PublicationTitleAlternate Lancet Diabetes Endocrinol
PublicationYear 2018
Publisher Elsevier Ltd
The Lancet, Diabetes & Endocrinology
Publisher_xml – name: Elsevier Ltd
– name: The Lancet, Diabetes & Endocrinology
References Linsenmeier (bib6) 1986; 88
Sivaprasad, Arden (bib7) 2016; 30
Altman (bib18) 1990
White, Horton, Carpenter, Pocock (bib15) 2011; 342
Osterberg, Blaschke (bib24) 2005; 353
Liu, Tang, Du (bib26) 2016; 57
White, Carpenter, Horton (bib16) 2012; 9
Dunn, Maracy, Dowrick (bib19) 2003; 183
Czanner, Gutu, Harding (bib21) 2015; 56
(bib4) 1985; 103
(bib5) 2007; 125
Sivaprasad, Arden, Prevost (bib11) 2014; 15
Tonade, Liu, Palczewski, Kern (bib27) 2017; 60
White, Thompson (bib17) 2005; 24
Friedman, Almukhtar, Baker (bib2) 2015; 35
Johns (bib12) 1991; 14
Tan, Cheung, Simó, Cheung, Wong (bib1) 2017; 5
Virgili, Parravano, Evans, Gordon, Lucenteforte (bib3) 2017; 6
Moul, Pilkonis, Miewald, Carey, Buysse (bib13) 2002; 25
Kuchynyka, Grierson, Veith (bib23) 2017; 7
Linsenmeier, Braun, McRipley (bib28) 1998; 39
Arden, Jyothi, Hogg, Lee, Sivaprasad (bib10) 2011; 25
Mallinckrod, Lane, Schnell, Peng, Mancuso (bib14) 2008; 42
(bib25) 2003
Arden, Gündüz, Kurtenbach (bib9) 2010; 24
Sahni, Czanner, Gutu (bib22) 2017; 31
Nguyen, Shah, Van Anden, Sung, Vitale, Campochiaro (bib8) 2004; 45
Ramsey, Arden (bib20) 2017; 58
29519745 - Lancet Diabetes Endocrinol. 2018 May;6(5):352-354
30613648 - Ann Transl Med. 2018 Nov;6(Suppl 1):S73
Linsenmeier (10.1016/S2213-8587(18)30036-6_bib6) 1986; 88
Arden (10.1016/S2213-8587(18)30036-6_bib9) 2010; 24
Sivaprasad (10.1016/S2213-8587(18)30036-6_bib11) 2014; 15
Johns (10.1016/S2213-8587(18)30036-6_bib12) 1991; 14
Tonade (10.1016/S2213-8587(18)30036-6_bib27) 2017; 60
White (10.1016/S2213-8587(18)30036-6_bib17) 2005; 24
Czanner (10.1016/S2213-8587(18)30036-6_bib21) 2015; 56
Tan (10.1016/S2213-8587(18)30036-6_bib1) 2017; 5
Liu (10.1016/S2213-8587(18)30036-6_bib26) 2016; 57
Sahni (10.1016/S2213-8587(18)30036-6_bib22) 2017; 31
Osterberg (10.1016/S2213-8587(18)30036-6_bib24) 2005; 353
(10.1016/S2213-8587(18)30036-6_bib4) 1985; 103
(10.1016/S2213-8587(18)30036-6_bib5) 2007; 125
Dunn (10.1016/S2213-8587(18)30036-6_bib19) 2003; 183
Moul (10.1016/S2213-8587(18)30036-6_bib13) 2002; 25
Mallinckrod (10.1016/S2213-8587(18)30036-6_bib14) 2008; 42
Ramsey (10.1016/S2213-8587(18)30036-6_bib20) 2017; 58
Altman (10.1016/S2213-8587(18)30036-6_bib18) 1990
Sivaprasad (10.1016/S2213-8587(18)30036-6_bib7) 2016; 30
(10.1016/S2213-8587(18)30036-6_bib25) 2003
Linsenmeier (10.1016/S2213-8587(18)30036-6_bib28) 1998; 39
Kuchynyka (10.1016/S2213-8587(18)30036-6_bib23) 2017; 7
Friedman (10.1016/S2213-8587(18)30036-6_bib2) 2015; 35
Nguyen (10.1016/S2213-8587(18)30036-6_bib8) 2004; 45
Arden (10.1016/S2213-8587(18)30036-6_bib10) 2011; 25
Virgili (10.1016/S2213-8587(18)30036-6_bib3) 2017; 6
White (10.1016/S2213-8587(18)30036-6_bib15) 2011; 342
White (10.1016/S2213-8587(18)30036-6_bib16) 2012; 9
References_xml – volume: 25
  start-page: 1546
  year: 2011
  end-page: 1554
  ident: bib10
  article-title: Regression of early diabetic macular oedema is associated with prevention of dark adaptation
  publication-title: Eye (Lond)
  contributor:
    fullname: Sivaprasad
– year: 1990
  ident: bib18
  article-title: Practical statistics for medical research
  contributor:
    fullname: Altman
– volume: 25
  start-page: A246
  year: 2002
  end-page: A247
  ident: bib13
  article-title: Preliminary study of the test-retest reliability and concurrent validities of the Pittsburgh Insomnia Rating Scale (PIRS)
  publication-title: Sleep
  contributor:
    fullname: Buysse
– year: 2003
  ident: bib25
  article-title: Adherence to long-term therapies. Evidence for action
– volume: 24
  start-page: 993
  year: 2005
  end-page: 1007
  ident: bib17
  article-title: Adjusting for partially missing baseline measurements in randomized trials
  publication-title: Stat Med
  contributor:
    fullname: Thompson
– volume: 57
  start-page: 4272
  year: 2016
  end-page: 4281
  ident: bib26
  article-title: Photoreceptor cells influence retinal vascular degeneration in mouse models of retinal degeneration and diabetes
  publication-title: Invest Ophthalmol Vis Sci
  contributor:
    fullname: Du
– volume: 15
  start-page: 458
  year: 2014
  ident: bib11
  article-title: A multicentre phase III randomised controlled single-masked clinical trial evaluating the clinical efficacy and safety of light-masks at preventing dark-adaptation in the treatment of early diabetic macular oedema (CLEOPATRA): study protocol for a randomised controlled trial
  publication-title: Trials
  contributor:
    fullname: Prevost
– volume: 14
  start-page: 540
  year: 1991
  end-page: 545
  ident: bib12
  article-title: A new method for measuring daytime sleepiness: the Epworth sleepiness scale
  publication-title: Sleep
  contributor:
    fullname: Johns
– volume: 183
  start-page: 323
  year: 2003
  end-page: 331
  ident: bib19
  article-title: Estimating psychological treatment effects from a randomised controlled trial with both non-compliance and loss to follow-up
  publication-title: Br J Psychiatry
  contributor:
    fullname: Dowrick
– volume: 88
  start-page: 521
  year: 1986
  end-page: 542
  ident: bib6
  article-title: Effects of light and darkness on oxygen distribution and consumption in the cat retina
  publication-title: J Gen Physiol
  contributor:
    fullname: Linsenmeier
– volume: 31
  start-page: 97
  year: 2017
  end-page: 106
  ident: bib22
  article-title: Safety and acceptability of an organic light-emitting diode sleep mask as a potential therapy for retinal disease
  publication-title: Eye (Lond)
  contributor:
    fullname: Gutu
– volume: 42
  start-page: 303
  year: 2008
  end-page: 319
  ident: bib14
  article-title: Recommendations for the primary analysis of continuous endpoints in longitudinal clinical trials
  publication-title: Drug Inf J
  contributor:
    fullname: Mancuso
– volume: 45
  start-page: 617
  year: 2004
  end-page: 624
  ident: bib8
  article-title: Supplemental oxygen improves diabetic macular edema: a pilot study
  publication-title: Invest Ophthalmol Vis Sci
  contributor:
    fullname: Campochiaro
– volume: 58
  year: 2017
  ident: bib20
  article-title: Investigating the Arden hypothesis: a pilot investigation of the prevention of dark adaptation as complementary therapy for diabetic retinopathy and macular edema
  publication-title: Invest Ophthalmol Vis Sci
  contributor:
    fullname: Arden
– volume: 342
  start-page: d40
  year: 2011
  ident: bib15
  article-title: Strategy for intention to treat analysis in randomised trials with missing outcome data
  publication-title: BMJ
  contributor:
    fullname: Pocock
– volume: 56
  year: 2015
  ident: bib21
  article-title: Safety and acceptability of an organic light emitting diode (OLED) sleep mask for the treatment of retinal diseases: INSIGHT Study
  publication-title: Invest Ophthalmol Vis Sci
  contributor:
    fullname: Harding
– volume: 60
  start-page: 2111
  year: 2017
  end-page: 2120
  ident: bib27
  article-title: Photoreceptor cells produce inflammatory products that contribute to retinal vascular permeability in a mouse model of diabetes
  publication-title: Diabetologia
  contributor:
    fullname: Kern
– volume: 353
  start-page: 487
  year: 2005
  end-page: 497
  ident: bib24
  article-title: Adherence to medication
  publication-title: N Engl J Med
  contributor:
    fullname: Blaschke
– volume: 7
  start-page: 00253
  year: 2017
  ident: bib23
  article-title: Patients with diabetic eye disease using a potentially therapeutic mask. Do sufficient patients wear the mask and for how long?
  publication-title: Adv Ophthalmol Vis Syst
  contributor:
    fullname: Veith
– volume: 5
  start-page: 143
  year: 2017
  end-page: 155
  ident: bib1
  article-title: Diabetic macular oedema
  publication-title: Lancet Diabetes Endocrinol
  contributor:
    fullname: Wong
– volume: 125
  start-page: 318
  year: 2007
  end-page: 324
  ident: bib5
  article-title: Effect of ruboxistaurin in patients with diabetic macular edema: thirty-month results of the randomized PKC-DMES clinical trial
  publication-title: Arch Ophthalmol
– volume: 6
  year: 2017
  ident: bib3
  article-title: Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis
  publication-title: Cochrane Database Syst Rev
  contributor:
    fullname: Lucenteforte
– volume: 39
  start-page: 1647
  year: 1998
  end-page: 1657
  ident: bib28
  article-title: Retinal hypoxia in long-term diabetic cats
  publication-title: Invest Ophthalmol Vis Sci
  contributor:
    fullname: McRipley
– volume: 35
  start-page: 944
  year: 2015
  end-page: 956
  ident: bib2
  article-title: Topical nepafenec in eyes with noncentral diabetic macular edema
  publication-title: Retina
  contributor:
    fullname: Baker
– volume: 9
  start-page: 396
  year: 2012
  end-page: 407
  ident: bib16
  article-title: Including all individuals is not enough: lessons for intention-to-treat analysis
  publication-title: Clin Trials
  contributor:
    fullname: Horton
– volume: 103
  start-page: 1796
  year: 1985
  end-page: 1806
  ident: bib4
  article-title: Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1
  publication-title: Arch Ophthalmol
– volume: 24
  start-page: 1149
  year: 2010
  end-page: 1155
  ident: bib9
  article-title: A preliminary trial to determine whether prevention of dark adaptation affects the course of early diabetic retinopathy
  publication-title: Eye (Lond)
  contributor:
    fullname: Kurtenbach
– volume: 30
  start-page: 189
  year: 2016
  end-page: 192
  ident: bib7
  article-title: Spare the rods and spoil the retina: revisited
  publication-title: Eye (Lond)
  contributor:
    fullname: Arden
– volume: 24
  start-page: 1149
  year: 2010
  ident: 10.1016/S2213-8587(18)30036-6_bib9
  article-title: A preliminary trial to determine whether prevention of dark adaptation affects the course of early diabetic retinopathy
  publication-title: Eye (Lond)
  doi: 10.1038/eye.2009.328
  contributor:
    fullname: Arden
– volume: 7
  start-page: 00253
  year: 2017
  ident: 10.1016/S2213-8587(18)30036-6_bib23
  article-title: Patients with diabetic eye disease using a potentially therapeutic mask. Do sufficient patients wear the mask and for how long?
  publication-title: Adv Ophthalmol Vis Syst
  contributor:
    fullname: Kuchynyka
– volume: 56
  year: 2015
  ident: 10.1016/S2213-8587(18)30036-6_bib21
  article-title: Safety and acceptability of an organic light emitting diode (OLED) sleep mask for the treatment of retinal diseases: INSIGHT Study
  publication-title: Invest Ophthalmol Vis Sci
  contributor:
    fullname: Czanner
– volume: 24
  start-page: 993
  year: 2005
  ident: 10.1016/S2213-8587(18)30036-6_bib17
  article-title: Adjusting for partially missing baseline measurements in randomized trials
  publication-title: Stat Med
  doi: 10.1002/sim.1981
  contributor:
    fullname: White
– volume: 183
  start-page: 323
  year: 2003
  ident: 10.1016/S2213-8587(18)30036-6_bib19
  article-title: Estimating psychological treatment effects from a randomised controlled trial with both non-compliance and loss to follow-up
  publication-title: Br J Psychiatry
  doi: 10.1192/bjp.183.4.323
  contributor:
    fullname: Dunn
– year: 1990
  ident: 10.1016/S2213-8587(18)30036-6_bib18
  contributor:
    fullname: Altman
– volume: 88
  start-page: 521
  year: 1986
  ident: 10.1016/S2213-8587(18)30036-6_bib6
  article-title: Effects of light and darkness on oxygen distribution and consumption in the cat retina
  publication-title: J Gen Physiol
  doi: 10.1085/jgp.88.4.521
  contributor:
    fullname: Linsenmeier
– volume: 30
  start-page: 189
  year: 2016
  ident: 10.1016/S2213-8587(18)30036-6_bib7
  article-title: Spare the rods and spoil the retina: revisited
  publication-title: Eye (Lond)
  doi: 10.1038/eye.2015.254
  contributor:
    fullname: Sivaprasad
– volume: 9
  start-page: 396
  year: 2012
  ident: 10.1016/S2213-8587(18)30036-6_bib16
  article-title: Including all individuals is not enough: lessons for intention-to-treat analysis
  publication-title: Clin Trials
  doi: 10.1177/1740774512450098
  contributor:
    fullname: White
– volume: 57
  start-page: 4272
  year: 2016
  ident: 10.1016/S2213-8587(18)30036-6_bib26
  article-title: Photoreceptor cells influence retinal vascular degeneration in mouse models of retinal degeneration and diabetes
  publication-title: Invest Ophthalmol Vis Sci
  doi: 10.1167/iovs.16-19415
  contributor:
    fullname: Liu
– volume: 25
  start-page: A246
  year: 2002
  ident: 10.1016/S2213-8587(18)30036-6_bib13
  article-title: Preliminary study of the test-retest reliability and concurrent validities of the Pittsburgh Insomnia Rating Scale (PIRS)
  publication-title: Sleep
  contributor:
    fullname: Moul
– volume: 58
  year: 2017
  ident: 10.1016/S2213-8587(18)30036-6_bib20
  article-title: Investigating the Arden hypothesis: a pilot investigation of the prevention of dark adaptation as complementary therapy for diabetic retinopathy and macular edema
  publication-title: Invest Ophthalmol Vis Sci
  contributor:
    fullname: Ramsey
– year: 2003
  ident: 10.1016/S2213-8587(18)30036-6_bib25
– volume: 45
  start-page: 617
  year: 2004
  ident: 10.1016/S2213-8587(18)30036-6_bib8
  article-title: Supplemental oxygen improves diabetic macular edema: a pilot study
  publication-title: Invest Ophthalmol Vis Sci
  doi: 10.1167/iovs.03-0557
  contributor:
    fullname: Nguyen
– volume: 353
  start-page: 487
  year: 2005
  ident: 10.1016/S2213-8587(18)30036-6_bib24
  article-title: Adherence to medication
  publication-title: N Engl J Med
  doi: 10.1056/NEJMra050100
  contributor:
    fullname: Osterberg
– volume: 31
  start-page: 97
  year: 2017
  ident: 10.1016/S2213-8587(18)30036-6_bib22
  article-title: Safety and acceptability of an organic light-emitting diode sleep mask as a potential therapy for retinal disease
  publication-title: Eye (Lond)
  doi: 10.1038/eye.2016.259
  contributor:
    fullname: Sahni
– volume: 103
  start-page: 1796
  year: 1985
  ident: 10.1016/S2213-8587(18)30036-6_bib4
  article-title: Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1
  publication-title: Arch Ophthalmol
  doi: 10.1001/archopht.1985.01050120030015
– volume: 14
  start-page: 540
  year: 1991
  ident: 10.1016/S2213-8587(18)30036-6_bib12
  article-title: A new method for measuring daytime sleepiness: the Epworth sleepiness scale
  publication-title: Sleep
  doi: 10.1093/sleep/14.6.540
  contributor:
    fullname: Johns
– volume: 6
  year: 2017
  ident: 10.1016/S2213-8587(18)30036-6_bib3
  article-title: Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis
  publication-title: Cochrane Database Syst Rev
  contributor:
    fullname: Virgili
– volume: 42
  start-page: 303
  year: 2008
  ident: 10.1016/S2213-8587(18)30036-6_bib14
  article-title: Recommendations for the primary analysis of continuous endpoints in longitudinal clinical trials
  publication-title: Drug Inf J
  doi: 10.1177/009286150804200402
  contributor:
    fullname: Mallinckrod
– volume: 60
  start-page: 2111
  year: 2017
  ident: 10.1016/S2213-8587(18)30036-6_bib27
  article-title: Photoreceptor cells produce inflammatory products that contribute to retinal vascular permeability in a mouse model of diabetes
  publication-title: Diabetologia
  doi: 10.1007/s00125-017-4381-5
  contributor:
    fullname: Tonade
– volume: 35
  start-page: 944
  year: 2015
  ident: 10.1016/S2213-8587(18)30036-6_bib2
  article-title: Topical nepafenec in eyes with noncentral diabetic macular edema
  publication-title: Retina
  doi: 10.1097/IAE.0000000000000403
  contributor:
    fullname: Friedman
– volume: 15
  start-page: 458
  year: 2014
  ident: 10.1016/S2213-8587(18)30036-6_bib11
  publication-title: Trials
  doi: 10.1186/1745-6215-15-458
  contributor:
    fullname: Sivaprasad
– volume: 125
  start-page: 318
  year: 2007
  ident: 10.1016/S2213-8587(18)30036-6_bib5
  article-title: Effect of ruboxistaurin in patients with diabetic macular edema: thirty-month results of the randomized PKC-DMES clinical trial
  publication-title: Arch Ophthalmol
  doi: 10.1001/archopht.125.3.318
– volume: 342
  start-page: d40
  year: 2011
  ident: 10.1016/S2213-8587(18)30036-6_bib15
  article-title: Strategy for intention to treat analysis in randomised trials with missing outcome data
  publication-title: BMJ
  doi: 10.1136/bmj.d40
  contributor:
    fullname: White
– volume: 25
  start-page: 1546
  year: 2011
  ident: 10.1016/S2213-8587(18)30036-6_bib10
  article-title: Regression of early diabetic macular oedema is associated with prevention of dark adaptation
  publication-title: Eye (Lond)
  doi: 10.1038/eye.2011.264
  contributor:
    fullname: Arden
– volume: 5
  start-page: 143
  year: 2017
  ident: 10.1016/S2213-8587(18)30036-6_bib1
  article-title: Diabetic macular oedema
  publication-title: Lancet Diabetes Endocrinol
  doi: 10.1016/S2213-8587(16)30052-3
  contributor:
    fullname: Tan
– volume: 39
  start-page: 1647
  year: 1998
  ident: 10.1016/S2213-8587(18)30036-6_bib28
  article-title: Retinal hypoxia in long-term diabetic cats
  publication-title: Invest Ophthalmol Vis Sci
  contributor:
    fullname: Linsenmeier
SSID ssj0001053680
Score 2.3550315
Snippet 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...
BACKGROUNDWe aimed to assess 24-month outcomes of wearing an organic light-emitting sleep mask as an intervention to treat and prevent progression of...
SourceID pubmedcentral
proquest
crossref
pubmed
elsevier
SourceType Open Access Repository
Aggregation Database
Index Database
Publisher
StartPage 382
SubjectTerms 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
Title 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
URI https://dx.doi.org/10.1016/S2213-8587(18)30036-6
https://www.ncbi.nlm.nih.gov/pubmed/29519744
https://search.proquest.com/docview/2012918432
https://pubmed.ncbi.nlm.nih.gov/PMC5908782
Volume 6
hasFullText 1
inHoldings 1
isFullTextHit
isPrint
link http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV1Zb9NAEF61qYR4QdwNlwYJpFauU3u98cFbKIUKlUM0VH2z1t41iZraUZPywO_lhzB7-OjBUV4sK_aONjvz7RyemSXkRRQVUUYL5nqFH7ssZ8LlgRCuQPnwgqSQYaazLT6Ge1_Z-6Ph0crqdidr6WyZDfIfV9aV_A9X8Tfkq6qSvQZnG6L4A94jf_GKHMbrP_F4py5rlKoRhDq4XYfBeSFNngV3Zsr3dk744ljnE85twyZjJAp-euxwwec241ClPGob0tYt1m_revXqm8mY1SOlbots4rbTHOmbbNZKCnnCVX0kZQ6uwnKiY7o7-7ufPo_GX0YvaWKKq3Uao84L1fHU-QR1qROoW1SdokLZk6LOop_hrT5bpGtHK-me6fLtgfOmDR-HjsThuBGe_1pwMP3O56d8YcT5oMomjTI65ItcVW7OKvtBhJe8jRyrBle2KmbkjKusodhWcmi93Y2doDA2mYpmi6XUD9x4aFW-1QdhR-yHnb09MKckWTMhMIeMXdJAJhhy0FDW7bZweQPd-vmKrt8XtHGTI9mk3ylSqSKV-nGqyaThKllTnR9Zj6y9e71_OGrDiriphvq8wGYGbd3adjutDT_etFP6nUV22eO6mDjcscTGt8kt60LByODhDlmR5V1y44NNErlHftawgBoWgEIFBhZQFcBBwwIULABhAS0s1GMFC2hhAdMSalhoQi0soAMLNVLDAmpYgIUFGFgAXwJlYGABGw0oNl_hhDqA2AINBwi2oAUDtGAADYb7ZPx2d7yz59rDTNwcbZGlK1ksoygQ1MsCHjOZK18rLHgkEvTpPZ7kYUyFz2ieRV4xzKjPI16wgkr0cYZh8ID0yqqU6wSkiCjPBZU4hsUBLmPisyIRjCvnJkr6ZFDzM52bljXpH4WpT-Ka66m1u409naJQ_23o81pKUlwO9bGRl7I6W6RURbjVYVK0Tx4aqWlmQxNVLs9Yn0Tn5Kl5QfW8P_-knE507_th4sXo1Dy67n98TG62G8AT0luensmn6E4ss2cWQr8AoLUg7Q
link.rule.ids 230,314,780,784,885,27924,27925
linkProvider Elsevier
openUrl ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=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+%28CLEOPATRA%29%3A+a+multicentre%2C+phase+3%2C+randomised+controlled+trial&rft.jtitle=The+lancet.+Diabetes+%26+endocrinology&rft.au=Sivaprasad%2C+Sobha&rft.au=Vasconcelos%2C+Joana+C&rft.au=Prevost%2C+A+Toby&rft.au=Holmes%2C+Helen&rft.date=2018-05-01&rft.issn=2213-8587&rft.volume=6&rft.issue=5&rft.spage=382&rft.epage=391&rft_id=info:doi/10.1016%2FS2213-8587%2818%2930036-6&rft.externalDBID=n%2Fa&rft.externalDocID=10_1016_S2213_8587_18_30036_6
thumbnail_l http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=2213-8587&client=summon
thumbnail_m http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=2213-8587&client=summon
thumbnail_s http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=2213-8587&client=summon