Scanning CONfoCal Ophthalmoscopy foR DIAbetic eye screening (CONCORDIA 2) in Asian and Afro-Caribbean Groups

Abstract Background: A study has been undertaken in Gloucestershire using a new type of Scanning Confocal Ophthalmoscope Camera (SCO - Eidon white light 60-degree field) which demonstrated that less than 5% of images taken without eye drops were ungradable and the camera detected a high level of both any retinopathy and sight threatening diabetic retinopathy in a principally White Caucasian population.

Objectives: The purpose of this study is to determine if the Eidon white light 60-degree field SCO camera is safe to use in staged mydriatic mode in a Diabetic Eye Screening Programme (DESP) for those people of Asian and Afro-Caribbean descent in a screening programme in Leyton Green in North East London that has 34.6% (6759) of Asian descent and 21.2% (4139) of Afro-Caribbean descent.

Methods: We propose a clinical trial to determine the sensitivity and specificity of the Eidon 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.

Study size: A total of 1800 patients will be recruited – 900 of Asian descent and 900 of Afro-Caribbean descent