Prospective EMERALD Study completed –
“Considering the great demand that eye services face, due to the increasing numbers of people with diabetes and, subsequently, DMO and PDR, implementation of EMERALD findings may help ophthalmic units across the world to improve their capacity and save patient’s sight.”
EMERALD (the Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy) was a prospective, case-referent, cross-sectional diagnostic accuracy study aimed at evaluating diagnostic performance, cost-effectiveness, and acceptability of a new health care pathway, the “ophthalmic grader” pathway, for the surveillance of people with previously treated and stable diabetic macular oedema (DMO) and proliferative diabetic retinopathy (PDR). The new pathway tested in EMERALD entailed multimodal imaging interpreted by ophthalmic graders. EMERALD was an investigator-led study funded by the Health Technology Assessment of the National Institute for Health Research (HTA-NIHR) in the UK.
EMERALD was set in 13 National Health Service (NHS) hospitals across the UK. Trained and tested ophthalmic graders reviewed spectral domain optical coherence tomography (SD-OCT) scans to determine whether there was reactivated DMO, and 7-field Early Treatment Diabetic Retinopathy Study (ETDRS) and ultra-wide field fundus images to determine whether there was reactivation of PDR. Their performance was compared with results of standard care (i.e. ophthalmologists examining patients face-to-face by slit-lamp biomicroscopy for PDR and, in addition, SD-OCT imaging for DMO).
EMERALD achieved full recruitment, with 397 eligible participants recruited, and found the ophthalmic grader pathway to be safe, having adequate diagnostic accuracy, and cost-saving, specifically being able to save Ophthalmologists time which could be then re-directed to the evaluation and/or treatment of patients with sight-threatening disease. EMERALD showed also that graders had higher sensitivity and specificity to identify active PDR with high-risk characteristics when using ultrawide field imaging than if using 7-field ETDRS images.
Participants attending focus group discussions, aimed at evaluating the acceptability of the new pathway by users, expressed preference for face-to-face evaluations by ophthalmologists but, in their absence, they would accept the ophthalmic grader’s pathway provided they would receive immediate feedback following grader’s assessments and periodic evaluations by an ophthalmologist from time to time, even if their condition were to remain stable. Graders and ophthalmologists, who also attended focus group meetings aim at addressing the acceptability of the new pathway by health care professionals, were supportive of the new pathway.
Considering the great demand that eye services face, due to the increasing numbers of people with diabetes and, subsequently, DMO and PDR, implementation of EMERALD findings may help ophthalmic units across the world to improve their capacity and save patient’s sight.