Proliferative diabetic retinopathy (PDR) and diabetic macular oedema (DMO) Eye Diseases 1. Proliferative diabetic retinopathy (PDR) 2. Diabetic macular edema (DME)
Conditions
Interventions
EMERALD has a case-referent cross-sectional diagnostic study design with both sampling (selection) of patients and data collection carried out prospectively.
Multimodal retinal imaging with subsequen
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 12/03/2019: 1. Adults (18 years of age or older) 2. Type 1 or 2 diabetes 3. Previously successfully treated DMO and/or PDR in one or both eyes and in whom, at the time of enrolment in the study 4. DMO and/or PDR may be active or inactive 4.1. 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 4.2. Inactive DMO will be defined as no intraretinal/subretinal fluid 4.3. 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) 4.4. Inactive PDR will be defined by the lack of preretinal/vitreous haemorrhage and lack of active new vessels Previous participant inclusion criteria: 1. Adults (18 years of age or older) 2. Type 1 or 2 diabetes 3. Previously successfully treated DMO and/or PDR in one or both eyes and in whom, at the time of enrolment in the study 4. DMO and/or PDR may be active or inactive 4.1. 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 4.2. Inactive DMO will be defined as a CRT of <300 microns and no intraretinal/subretinal fluid 4.3. 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) 4.4. Inactive PDR will be defined by the lack of preretinal/vitreous haemorrhage and lack of active new vessels
Exclusion criteria
Exclusion criteria: 1. Unable to provide informed consent 2. Patients do not read, speak or understand English
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Specificity, concordance (agreement) between the new pathway (ophthalmic grader pathway) and the standard care pathway, positive and negative likelihood ratios are assessed by evaluating the CRFs at baseline 2. Cost-effectiveness is assessed by evaluating the CRFs and the EQ-5D questionnaire at baseline 3. Acceptability is assessed by evaluating the Focus Group Discussion feedback at baseline 4. Proportion of patients requiring subsequent full clinical assessment is assessed by evaluating the CRFs at baseline 5. Proportion of patients unable to undergo imaging, with inadequate quality images or indeterminate findings, is assessed by evaluating the CRFs at baseline | — |
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR is assessed by evaluating the Case Report Forms (CRFs) at baseline | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Contacts
Public ContactLynn Murphy
Outcome results
None listed