| Trial Acronym | EMERALD |
| Clinical Area | Diabetic macular oedema (DMO) and proliferative diabetic retinopathy (PDR) |
| Description | Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy |
| Status | Closed |
The EMERALD Trial is now complete. If you wish to discuss the EMERALD study, please email info@nictu.hscni.net
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Recruitment
Date Opened to Recruitment Expected 1st October 2017 Target Recruitment 416 Recruitment to date 274 Date Closed to Recruitment N/A No. of Sites 13 -
Trial Design
Trial Design Prospective, cross-sectional diagnostic study
.Study Aim EMERALD aims to determine the diagnostic performance and cost-effectiveness of a new form of surveillance for people with stable DMO and/or PDR, using the current standard of care as the reference standard.
The specific objectives of this study are to evaluate the new surveillance pathway to:1. Quantify and compare the diagnostic accuracy (in terms of sensitivity, specificity, overall agreement, positive and negative likelihood ratios) of the new pathway of surveillance (ophthalmic grader pathway) using the current standard of care pathway as the reference standard. This will be done separately for DMO and PDR.
2. Assess acceptability of the new surveillance pathway.
3. Determine the proportion of patients requiring subsequent full clinical assessment by an ophthalmologist under the new pathway.
4. Determine the proportion of patients unable to undergo imaging tests, with images of inadequate quality and indeterminate findings under the new pathway.
5. Establish relative cost-effectiveness of the new surveillance pathway. -
Chief Investigator
Chief Investigator Professor Noemi Lois -
Sponsor & Funder
Sponsors Belfast Health and Social Care Trust Funder National Institute of Health Research (NIHR)