Assessing whether the images taken of the back of the eye using new devices called scanning confocal ophthalmoscopes are of suitable quality to be used in the diabetic eye screening programme for the diagnosis of diabetic eye disease

Not Applicable

Completed

• Conditions: Diabetic eye disease; Eye Diseases; Diabetic retinopathy

• Registration Number: ISRCTN16254044
• Lead Sponsor: Gloucestershire Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-14
• Study Completion: 2023-05-31
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 867

Inclusion Criteria

1. People with diabetes giving informed consent
2. Those that meet the inclusion criteria for the 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified