Diabetic eye screening Eye Diseases
Conditions
Interventions
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 an
Sponsors
Gloucestershire Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
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 Eidon device 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 at a single timepoint at the routine screening appointment | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at a single timepoint at the routine screening appointment: 1. Sensitivity and specificity of the device 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 measured using recorded data 3. Proportion of images that are gradable on the Eidon SCO device that are ungradable on the digital images measured using recorded data 4. Inter-and intra-grader agreement for detecting any DR measured using recorded data 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. The screener and participant’s perspectives of the device measured using a graphical feedback question 7. Lesions detected outside the standard fields and whether this alters the NSC grade or referral outcome measured using recorded data | — |
Countries
England, United Kingdom
Contacts
Public ContactPeter Scanlon
Outcome results
None listed