Diabetic retinopathy Eye Diseases Diabetic retinopathy
Conditions
Interventions
Participant demographics and baseline characteristics will be captured as well as height, weight, waist and hip measurements and blood pressure. Retinal imaging and OCT scans will be performed on pati
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults > 40 years of age 2. Ability to give informed consent 3. Patient has to meet ONLY ONE of the criteria below to be included in this study: 3.1. Patient is not diabetic 3.2. Patient is Type 2 DM for > 5 years but no diabetic retinopathy in both eyes 3.3. Mild/Moderate/Severe NPDR with DMO defined as morphological OCT evidence of macular oedema in the worse eye in the last 12 months 3.4. Active PDR with or without diabetic macular oedema in the worse eye (newly diagnosed treatment naïve or being treated with PRP and/or VR surgery in the last 2 years)
Exclusion criteria
Exclusion criteria: 1. Type 1 Diabetes Mellitus 2. Type 2 Diabetes Mellitus 180 mmHg or diastolic > 110 mmHg 5. Pregnant and breast feeding women 6. Patient on corticosteroids or immunosuppression 7. Major ocular conditions like uveitis, glaucoma, AMD, vasculitis, occlusion etc in either eye 8. Any ocular conditions other than diabetic retinopathy/maculopathy affecting vision in either eye – for e.g. epiretinal membrane, vitreomacular traction etc 9. Cataract surgery or any ocular surgery in the last 3 months in either eye 10. Significant cataract affecting adequate fundus photographs in either eye 11. Mild/Moderate/Severe NPDR without DMO in worse eye (study eye)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of novel and existing circulating biomarkers for sight threatening retinopathy; the sensitivity, specificity and receiver operating characteristics (ROC) curves will be reported. As it is a cross-sectional study, there is a one-off blood collection, analysis and reporting. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnostic accuracy of novel and existing circulating biomarkers for any diabetic retinopathy 2. Diagnostic accuracy of novel and existing circulating biomarkers for identifying people at risk of microvascular and/or macrovascular complications of diabetes The sensitivity, specificity and receiver operating characteristics (ROC) curves will be reported. As it is a cross-sectional study, there is a one-off blood collection, analysis and reporting. | — |
Countries
England, United Kingdom
Outcome results
None listed