Imperial College London
Alternate

Professor Toby Prevost

Faculty of Medicine, School of Public Health

Visiting Professor
 
 
 
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Contact

 

a.prevost

 
 
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Location

 

57Stadium HouseWhite City Campus

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Summary

 

Publications

Citation

BibTex format

@article{Sivaprasad:2018:10.1016/S2213-8587(18)30036-6,
author = {Sivaprasad, S and Vasconcelos, JC and Prevost, AT and Holmes, H and Hykin, P and George, S and Murphy, C and Kelly, J and Arden, GB},
doi = {10.1016/S2213-8587(18)30036-6},
journal = {Lancet Diabetes and Endocrinology},
pages = {382--391},
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},
url = {http://dx.doi.org/10.1016/S2213-8587(18)30036-6},
volume = {6},
year = {2018}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - 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 a
AU  - Sivaprasad,S
AU  - Vasconcelos,JC
AU  - Prevost,AT
AU  - Holmes,H
AU  - Hykin,P
AU  - George,S
AU  - Murphy,C
AU  - Kelly,J
AU  - Arden,GB
DO  - 10.1016/S2213-8587(18)30036-6
EP  - 391
PY  - 2018///
SN  - 2213-8595
SP  - 382
TI  - 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
T2  - Lancet Diabetes and Endocrinology
UR  - http://dx.doi.org/10.1016/S2213-8587(18)30036-6
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000430631600015&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - http://hdl.handle.net/10044/1/71846
VL  - 6
ER  -
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