Diabetic eye disease Eye Diseases Diabetic retinopathy
Conditions
Interventions
The interventions are three different SCO devices that are compared with the standard digital images taken in the English National Screening programme.
Work package 1 is using data from two devices (
Sponsors
Gloucestershire Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. People with diabetes giving informed consent 2. Those that meet the inclusion criteria for the national diabetic eye screening programme (DESPs), who are people with diabetes over the age of 12 years except for those under 16 years attending their first screening appointment
Exclusion criteria
Exclusion criteria: 1. People in whom it is not possible to take retinal images (it is normally not possible to obtain adequate images to grade in a small number of people in a screening population due to opacities in the media e.g. cataract, corneal scarring etc or due to disability making it impossible for the individual to place their chin on a chin rest and other forms of screening are required in these individuals) 2. People or parents unable or unwilling to give informed consent 3. Those with eye disease that might affect interpretation of DR levels e.g. branch or central retinal vein occlusion 4. Children under 16 years of age attending for their first retinal screening appointment, which will automatically exclude children 12 years old and under as this is when they are first invited
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of the Optos, Clarus and Eidon devices for detecting any diabetic retinopathy within the area of the two 45-degree field mydriatic images against a reference standard of two-field digital photography. All the data are collected at a single timepoint which is at the routine screening appointment. | — |
Secondary
| Measure | Time frame |
|---|---|
| All the data are collected at a single timepoint which is at the routine screening appointment: 1. Sensitivity and specificity of the SCO devices for detecting referable DR within the area of the two 45-degree field mydriatic digital images against a reference standard of two-field digital photography 2. Proportion of ungradable images 3. Proportion of images that are gradable on the Eidon SCO device that are ungradable on the digital images 4. Inter-and intra-grader agreement for detecting any DR 5. Microaneurysm counts within 1DD of the central fovea, the macular area, and the area of the two 45-degree fields (SCO images and digital images) 6. Screener and participant’s perspectives of the device assessed using a graphical feedback question 7. Lesions detected outside the standard fields by the Optos, Clarus and Eidon devices and whether this alters the NSC grade or referral outcome 8. Health-related quality of life measured using the EuroQol EQ-5D-5L to support the cost-effectiveness study (for work package 3) 9. Time taken to capture and grade images by device type recorded automatically via the software used in the screening department (for the health economic analysis in work package 3) | — |
Countries
England, United Kingdom
Contacts
Public ContactLaura Lodge
Outcome results
None listed