Scanning CONfoCal Ophthalmoscopy foR DIAbetic eye screening (CONCORDIA 2) in Asian and Afro-Caribbean Groups
Diabetic eye screening
We propose a clinical trial to determine the sensitivity and specificity of the EIDON scanning confocal ophthalmoscope (SCO) camera using a staged mydriatic approach in a screening cohort to detect any retinopathy in the central area covered by the standard two 45-degree photographs used in the English NHS DESP, and the proportion of ungradable images. All participants will have images of their retinas taken with an EIDON SCO camera without mydriasis. The total duration of participation in the trial is around 30 minutes per participant, as they will have additional images taken with the new device before their pupils are dilated and then have their normal screening images taken for comparison. They will be asked to complete a short satisfaction questionnaire. If the images on the new device are not readable, they will be re-taken after the pupils are dilated. After this, their participation is finished as there is no follow-up for the study.
1. People with diabetes giving informed consent 2. Those that meet the inclusion criteria for the National DESPs who are people with diabetes over the age of 12 years except for those under 16 years attending their first screening appointment 3. Asian or Afro-Caribbean descent
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