Diabetic eye disease Eye Diseases Diabetic retinopathy
Conditions
Interventions
The interventions are two different scanning confocal ophthalmoscopes (SCO) devices (the Optos California and Zeiss Clarus Scanning ophthalmoscopes) and the images are compared with the standard digit
Sponsors
Gloucestershire Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. People with diabetes giving informed consent 2. Those meeting the inclusion criteria for the English 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 2. People or parents unable or unwilling to give informed consent 3. Those with eye disease that might affect the interpretation of DR levels 4. Children under 16 years attending for their first retinal screening appointment, which will automatically exclude 12 year old children as this is when they are first invited
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence or absence of diabetic eye disease in the retinal images taken by the Optos California and Zeiss Clarus Scanning ophthalmoscope as assessed by the grading system used in the England Diabetic Eye screening service at a single timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of those with non-mydriatic images that the screener considers are ungradable and decides that a mydriatic image is required with that SCO device, measured using the grading system used in the England Diabetic Eye screening service at a single timepoint 2. The proportion of those in whom a second mydriatic image is taken that then become gradable, measured using the grading system used in the England Diabetic Eye screening service at a single timepoint 3. Screener and participant's perspectives on the devices: 3.1. Participant feedback: immediately after imaging on the SCO device, participants will be asked to complete a graphical feedback question. Participants will be asked to score the experience of the SCO devices from one of four options: No problem, Okay, Not nice, unpleasant. 3.2. Research imager feedback: as soon as each participant has completed imaging on each SCO device and has left the room, the imager will score the experience of screening the patient on each SCO from one of the following four options: No problem, Okay, Difficult, Very difficult. 4. Time taken to capture and grade images by device type. The time taken to capture the images is recorded automatically via the software used in the screening department. The graders will record the time spent grading each image. 5. Quality of life measured using the EuroQuol EQ-5D 5L at the screening appointment. The researchers will convert the responses to the EQ-5D-5L instrument into health utilities as per national guidelines (https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/technology-appraisal-guidance/eq-5d-5l) 6. Seek consent from participants to link images with their clinical information relating to diabetic care for a future cost-benefit analysis. Data from outcomes 3-6 will contribute to the CONCORDIA 1 study | — |
Countries
England, United Kingdom
Contacts
Public ContactLaura Lodge
Outcome results
None listed