MRCP(UK), 4 on behalf of the EMERALD Study Group 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 lifelong 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 7field 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%e99%) and specificity of 31% (95% CI, 23%e40%) to detect DME. For PDR, sensitivity and specificity using 7-field ETDRS images (85% [95% CI, 77%e91%] and 48% [95% CI, 41%e56%], respectively) or UWF images (83% [95% CI, 75%e89%] and 54% [95% CI, 46%e61%], respectively) were comparable. For detection of high-risk PDR, sensitivity and specificity were higher when using UWF images (87% [95% CI, 78%e93%] and 49% [95% CI, 42%e56%], respectively, for UWF versus 80% [95% CI, 69e88%] and 40% [95% CI, 34%e47%], 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. Ophthalmology 2020;-:1e13
Background/objectives Optical coherence tomography angiography (OCT-A) allows non-invasive imaging of chorio-retinal vasculature, and is a potential alternative to fluorescein angiography (FA). Sensitivity and specificity of OCT-A for detecting choroidal neovascularisation (CNV) in treatment-naïve neovascular age-related macular degeneration (nAMD) patients is examined, using the Heidelberg Spectralis in a 'real world' setting. Subject/methods Overall, 43 eyes from 26 patients were included in the study. Spectral domain OCT (SD-OCT), OCT-A and FA images were obtained at baseline. Each of the three retinal image modalities was systematically assessed by three masked clinicians. Decisions about the presence/absence of CNV were recorded using an automated segmentation for OCT-A, a manual method, and using both OCT-A and SD-OCT in conjunction. Additional information about the presence of subretinal hyper-reflective material (SHRM) and the 'double layer sign' (DLS) were recorded. ResultsThe average sensitivity and specificity of the OCT-A for the detection of CNV in treatment naïve AMD was 89% and 87% for the combined SD-OCT and OCT-A, 76% and 91% for the automated segmentation and 84% and 85% for the manual segmentation, respectively. Inter-clinician agreement was 0.59-65 kappa. In patients without CNV, SHRM was present in only 6% while DLS was present in 28%. Sensitivity and specificity was >78% for both SHRM and DLS. Conclusions OCT-A provides a reliable tool for detecting CNV in treatment naïve nAMD patients, with high sensitivity and specificity. Combined use of SD-OCT images and SHRM as an additional bio-marker, OCT-A could become an alternative to FA in routine clinical practice.
Indeed, in EMERALD, we used the Optos system (Optos plc) to obtain ultrawide field fundus images. The models used included the Optos 200Tx and the newest model Optos California. We obtained images under mydriasis, either with tropicamide 1.0% or with both tropicamide 1.0% and phenylephrine 2.5%.We agree with the authors that other problems that may be detected in clinic, such as increased intraocular pressure, neovascularization in the iris or angle, and cataract, will not be detected by fundus images or OCT examinations. We do not envision (nor do we recommend) patients to be reviewed only, for life, in the ophthalmic grader pathway. As we stated in our article, "it would be important that, from time to time, patients whose disease remains inactive are still seen by ophthalmologists." This will not only allow for the detection of other po-
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