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Purpose The increasing diabetes prevalence and advent of new treatments for its major visual-threatening complications (diabetic macular edema [DME] and proliferative diabetic retinopathy [PDR]), which require frequent life-long follow-up, have increased hospital demands markedly. Subsequent delays in patient's evaluation and treatment are causing sight loss. Strategies to increase capacity are needed urgently. The retinopathy (EMERALD) study tested diagnostic accuracy, acceptability, and costs of a new health care pathway for people with previously treated DME or PDR. Design Prospective, multicenter, case-referent, cross-sectional, diagnostic accuracy study undertaken in 13 hospitals in the United Kingdom. Participants Adults with type 1 or 2 diabetes previously successfully treated DME or PDR who, at the time of enrollment, had active or inactive disease. Methods A new health care pathway entailing multimodal imaging (spectral-domain OCT for DME, and 7-field Early Treatment Diabetic Retinopathy Study [ETDRS] and ultra-widefield [UWF] fundus images for PDR) interpreted by trained nonmedical staff (ophthalmic graders) to detect reactivation of disease was compared with the current standard care (face-to-face examination by ophthalmologists). Main Outcome Measures Primary outcome: sensitivity of the new pathway. Secondary outcomes: specificity; agreement between pathways; costs; acceptability; proportions requiring subsequent ophthalmologist assessment, unable to undergo imaging, and with inadequate images or indeterminate findings. Results The new pathway showed sensitivity of 97% (95% confidence interval [CI], 92%–99%) and specificity of 31% (95% CI, 23%–40%) to detect DME. For PDR, sensitivity and specificity using 7-field ETDRS images (85% [95% CI, 77%–91%] and 48% [95% CI, 41%–56%], respectively) or UWF images (83% [95% CI, 75%–89%] and 54% [95% CI, 46%–61%], respectively) were comparable. For detection of high-risk PDR, sensitivity and specificity were higher when using UWF images (87% [95% CI, 78%–93%] and 49% [95% CI, 42%–56%], respectively, for UWF versus 80% [95% CI, 69–88%] and 40% [95% CI, 34%–47%], respectively, for 7-field ETDRS images). Participants preferred ophthalmologists’ assessments; in their absence, they preferred immediate feedback by graders, maintaining periodic ophthalmologist evaluations. When compared with the current standard of care, the new pathway could save £1390 per 100 DME visits and between £461 and £1189 per 100 PDR visits. Conclusions The new pathway has acceptable sensitivity and would release resources. Users’ suggestions should guide implementation.

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.Pragmatic, multicenter, allocation-concealed, double-masked, randomized, non-inferiority trial.Adults with400μ center-involved DME and best-corrected visual acuity (BCVA)24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in one/both eyes.Randomisation 1:1 to 577nm SML or SL; retreatments were allowed. Rescue with intravitreal anti-vascular endothelial growth factor therapies or steroids was permitted if10 ETDRS-letter-loss and/or CRT increased400μ.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.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.SML was equivalent to SL, requiring slightly higher laser treatments.