Diabetic Macular Edema Clinical Trial
— EMERALDOfficial title:
Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
Verified date | February 2022 |
Source | Belfast Health and Social Care Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Given the high number of people with DMO and PDR, the need for patients to be seen at short follow-up intervals, the need for frequent treatments and the requirement for long-term follow-up, there is a very large workload in Hospital Eye Services related to DMO/PDR which is making it difficult for the NHS to cope with the demand, in particular, due to shortage of ophthalmologists. This is only expected to get worse given the increasing prevalence of DM. Identifying new ways of increasing the NHS capacity and efficiency without compromising the quality of care would greatly benefit the NHS. The purpose of this study is to determine whether successfully treated patients with DMO and PDR could be followed up without a face-to-face examination by an ophthalmologist. EMERALD will evaluate a new care pathway which will include multimodal retinal imaging and separate image assessment by trained ophthalmic graders. This new pathway will be compared to the current standard care pathway: for DMO: ophthalmologist evaluating patients in clinic by slit-lamp biomicroscopy and with access to OCT images; for PDR ophthalmologists evaluating patients in clinic by slit-lamp biomicroscopy. EMERALD will compare how accurate the new pathway is at determining which patients have active or inactive disease. The costs and acceptability of current and new models of care will also be compared.
Status | Completed |
Enrollment | 401 |
Est. completion date | December 23, 2019 |
Est. primary completion date | December 23, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults (18 years of age or older) with type 1 or 2 diabetes with previously successfully treated DMO and/or PDR in one or both eyes and in whom, at the time of enrolment in the study, DMO and/or PDR may be active or inactive. - Active DMO will be defined as a central subfield retinal thickness (CRT) of > 300 microns and/or presence of intraretinal/subretinal fluid on spectral domain OCT. - Inactive DMO will be defined as no intraretinal/subretinal fluid - Active PDR will be defined by the presence of sub-hyaloid/vitreous haemorrhage and/or active new vessels (new vessels with lack of fibrosis on them) - Inactive PDR will be defined by the lack of preretinal/vitreous haemorrhage and lack of active new vessels. Exclusion Criteria: - Unable to provide informed consent - Patients do not read, speak or understand English |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Victoria Hospital | Belfast | |
United Kingdom | Bradford Royal Infirmary | Bradford | |
United Kingdom | Bristol Eye Hospital | Bristol | |
United Kingdom | Queen Margaret Hospital | Dunfermline | Scotland |
United Kingdom | Frimley Park Hospital | Frimley | |
United Kingdom | Gloucestershire Royal Hospital | Gloucester | |
United Kingdom | King's College Hospital | London | |
United Kingdom | Moorfields eye Hospital | London | |
United Kingdom | Manchester Eye Hospital | Manchester | |
United Kingdom | James Cook University Hopsital | Middlesbrough | North Yorkshire |
United Kingdom | Oxford John Radcliffe Hospital | Oxford | |
United Kingdom | Sheffield Eye Hospital | Sheffield | |
United Kingdom | City Hopsitals Sunderland | Sunderland |
Lead Sponsor | Collaborator |
---|---|
Belfast Health and Social Care Trust | National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR, using the standard care pathway as the reference standard. | Sensitivity analysis | 30 months | |
Secondary | Specificity, concordance (agreement) between new pathway (ophthalmic grader pathway) and the standard care pathway, positive and negative likelihood ratios | specificity, concordance, positive and negative likelihood ratios | 30 months | |
Secondary | Cost-effectiveness | specificity analysis, QALY | 30 months | |
Secondary | Acceptability | specificity, concordance, positive and negative likelihood ratios | 30 months | |
Secondary | Proportion of patients requiring subsequent full clinical assessment | specificity, concordance, positive and negative likelihood ratios | 30 months | |
Secondary | Proportions of patients unable to undergo imaging, with inadequate quality images or indeterminate findings. | specificity, concordance, positive and negative likelihood ratios | 30 months |
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