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DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser (DIAMONDS) : a randomized double-masked non-inferiority clinical trial
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The DIAMONDS study group (Including:
). (2023) DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser (DIAMONDS) : a randomized double-masked non-inferiority clinical trial. Ophthalmology, 130 (1). pp. 14-27. doi:10.1016/j.ophtha.2022.08.012 ISSN 0161-6420.
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Official URL: http://doi.org/10.1016/j.ophtha.2022.08.012
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.
| Item Type: | Journal Article | ||||||||||
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| Subjects: | R Medicine > RE Ophthalmology | ||||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Vascular endothelial growth factors -- Antagonists, Diabetic retinopathy, Macula lutea -- Diseases, Edema, Lasers in ophthalmology, Ophthalmology | ||||||||||
| Journal or Publication Title: | Ophthalmology | ||||||||||
| Publisher: | Elsevier Inc. | ||||||||||
| ISSN: | 0161-6420 | ||||||||||
| Official Date: | January 2023 | ||||||||||
| Dates: |
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| Volume: | 130 | ||||||||||
| Number: | 1 | ||||||||||
| Page Range: | pp. 14-27 | ||||||||||
| DOI: | 10.1016/j.ophtha.2022.08.012 | ||||||||||
| Status: | Peer Reviewed | ||||||||||
| Publication Status: | Published | ||||||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||||||
| Copyright Holders: | Elsevier | ||||||||||
| Date of first compliant deposit: | 12 December 2022 | ||||||||||
| Date of first compliant Open Access: | 12 December 2022 | ||||||||||
| RIOXX Funder/Project Grant: |
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