DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser (DIAMONDS) : a randomized double-masked non-inferiority clinical trial

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Abstract

Purpose
Determine clinical-effectiveness, safety, and cost-effectiveness of subthreshold micropulse laser (SML), compared with standard laser (SL), for diabetic macular edema (DME) with central retinal thickness (CRT) <400μ.
Design
Pragmatic, multicenter, allocation-concealed, double-masked, randomized, non-inferiority trial.
Participants
Adults with <400μ center-involved DME and best-corrected visual acuity (BCVA) >24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in one/both eyes.
Intervention
Randomisation 1:1 to 577nm SML or SL; retreatments were allowed. Rescue with intravitreal anti-vascular endothelial growth factor therapies or steroids was permitted if >10 ETDRS-letter-loss and/or CRT increased >400μ.
Outcomes
Primary: Mean change in BCVA in the study eye at 24 months (non-inferiority margin 5 ETDRS-letters). Secondary: mean change from baseline to month-24 in binocular BCVA; CRT and mean deviation (MD) of Humphrey 10-2 visual field in the study eye; percentage meeting driving standards; EuroQoL (EQ-5D-5L), National Eye Institute-Visual Function Questionnaire (NEI-VFQ25), and Vision and Quality of Life Index (VisQoL) scores; cost per quality-adjusted life year (QALY) gained; adverse effects; number of laser and rescue treatments.
Results
DIAMONDS recruited fully (n=266); 87% SML and 86% SL had primary outcome data. Mean BCVA change from baseline to month-24 was -2.43 (Standard Deviation [SD] 8.20) and -0.45 (SD 6.72) in SML and SL, respectively. SML was deemed not only non-inferior but also equivalent to SL as the 95% confidence interval (CI) (-3.9 to -0.04) lay wholly within both upper and lower margins of the permitted maximum difference (5 ETDRS-letters). There was no statistically significant difference in binocular BCVA (0.32 ETDRS letters; 95% CI -0.99, 1.64; p = 0.63), CRT (-0.64 microns; 95% CI -14.25, 12.98; p = 0.93), MD (0.39 dB; 95% CI -0.23, 1.02; p = 0.21), meeting driving standards (% point difference 1.6, 95% CI -25.3, 28.5; p=0.91), adverse effects (Risk Ratio 0.28, 95% CI 0.06, 1.34; p=0.11), rescue treatments (% point difference -2.8, 95% CI -13.1, 7.5; p=0.59) or EQ-5D/VFQ-25/VisQoL scores. Number of laser treatments was higher in SML (0.48; 95% CI 0.18, 0.79; p = 0.002). Base-case analysis indicated no differences in costs or QALYs.
Conclusions
SML was equivalent to SL, requiring slightly higher laser treatments.

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