Ultra-widefield diabetic retinopathy screening
Research type
Research Study
Full title
Ultra-widefield retinal imaging for diabetic retinopathy screening
IRAS ID
156927
Contact name
Nigel Davies
Contact email
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
Across the UK, patients known to have diabetes are invited at least annually to attend diabetic retinopathy screening. A fundus camera is used to produce two overlapping images of the posterior of the retina. Following a nationally agreed protocol, patients in whom referable diabetic retinopathy is detected in their images are referred to the hospital eye service.
An alternative imaging device for diabetic retinopathy screening is potentially a "Daytona" (Optos plc, Dunfermline) ultra-widefield scanning laser ophthalmoscope (UWF-SLO). This would have the advantage of obtaining a larger retinal field being imaged in a single photograph for each eye. Optos plc received CE mark clearance for the Daytona UWF-SLO in November 2011.
The aim of this study will be to evaluate the effectiveness of a computer program designed to assess diabetic retinopathy in images captured by the Daytona UWF-SLO.
Patients attending screening for diabetic retinopathy and who consent to participate will be imaged by the Daytona device at the start of their appointment. They will then continue to their routine screening photography.
Approximately 600 patients (including 100 with referable diabetic retinopathy) attending Kensington Chelsea & Westminster Diabetic Eye Screening Service, a service contracted to 1st Retinal Screen Ltd, will be imaged in this way. 1st Retinal Screen staff will operate the Daytona device, undertake the routine appointment and grade the images.
Anonymised images will be processed by Optos automated diabetic retinopathy grading software. The result will be compared to the manual grading allowing the sensitivity (true positive rate) and specificity (true negative rate) of the software for the detection for diabetic retinopathy to be estimated. The automated grading result will not be linked to the patient identifiable data and will not influence patient care.
1st Retinal Screen Ltd will receive funding from Optos plc for this study.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
14/EM/1196
Date of REC Opinion
29 Oct 2014
REC opinion
Further Information Favourable Opinion