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2018 ; 6
(5
): 382-391
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English Wikipedia
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
#MMPMID29519744
Sivaprasad S
; Vasconcelos JC
; Prevost AT
; Holmes H
; Hykin P
; George S
; Murphy C
; Kelly J
; Arden GB
Lancet Diabetes Endocrinol
2018[May]; 6
(5
): 382-391
PMID29519744
show ga
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 ?m [SE 2·5] for the light mask vs -12·9 ?m [SE 2·9] for the sham
mask; adjusted mean difference -0·65 ?m, 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.
|*Dark Adaptation
[MESH]
|*Phototherapy/instrumentation/methods
[MESH]
|Aged
[MESH]
|Diabetic Retinopathy/*complications
[MESH]
|Disease Progression
[MESH]
|Female
[MESH]
|Humans
[MESH]
|Macular Edema/complications/diagnostic imaging/*prevention & control
[MESH]