Evaluating a new camera for diabetic eye disease screening in Afro-Caribbean and Asian populations without pupil dilation
| ISRCTN | ISRCTN18020816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18020816 |
| IRAS number | 336593 |
| Secondary identifying numbers | 24/0006674, CPMS 59470 |
- Submission date
- 27/11/2024
- Registration date
- 20/01/2025
- Last edited
- 12/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
People with diabetes can lose their sight because diabetes can damage their eyes. This damage can be detected early by taking pictures of the back of the eyes. Usually, eye drops are needed to get good quality pictures. Newer cameras, like the EIDON camera, might take high-quality images without needing eye drops. In Gloucestershire, 9 out of 10 people didn't need eye drops with these new cameras. This study aims to see if these new cameras work without eye drops in other areas of the country.
Who can participate?
People with diabetes who are scheduled for eye screening at Leyton Green in London can participate in this study.
What does the study involve?
Participants will receive a patient information leaflet two weeks before their eye screening appointment. On arrival, the study will be explained, and written consent will be taken. Participants will provide information on their sex, age, and ethnicity. The research imager will take one photograph of each eye with the EIDON camera without eye drops. Participants will then undergo the routine screening procedure, which includes using eye drops and taking two images of each eye. If the initial images from the EIDON camera are of poor quality, they will be repeated after using eye drops.
What are the possible benefits and risks of participating?
The main benefit is the potential to avoid the discomfort of eye drops, which can sting and blur vision, making it hard to drive or work afterwards. If the EIDON camera works well without eye drops, it could improve the screening experience for many people with diabetes. The risks are minimal, but there is a chance that the initial images might not be clear, requiring the use of eye drops as usual.
Where is the study run from?
Gloucestershire Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2024 to December 2026.
Who is funding the study?
Diabetes UK.
Who is the main contact?
Prof Peter Scanlon, p.scanlon@nhs.net
Contact information
Public, Scientific, Principal Investigator
Gloucestershire Hospitals NHSFT, GRRG Offices above Oakley Ward, Cheltenham General Hospital, Sandford Road
Cheltenham
GL53 7AN
United Kingdom
 ORCID ID |
0000-0001-8513-710X |
|---|---|
| Phone | +44 300422 2851 |
| p.scanlon@nhs.net |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Diagnostic, Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Scanning CONfoCal Ophthalmoscopy foR DIAbetic eye screening (CONCORDIA 2) in Asian and Afro-Caribbean Groups |
| Study acronym | CONCORDIA 2 |
| Study 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 London, England. |
| Ethics approval(s) |
Approved 11/09/2024, Black Country Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8010; blackcountry.rec@hra.nhs.uk), ref: 24/WM/0182 |
| Health condition(s) or problem(s) studied | Diabetic eye screening |
| Intervention | 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. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | EIDON Scanning confocal ophthalmoscope |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 11/09/2024 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 12 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 1800 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2025 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leyton
London
E10 6BL
United Kingdom
Sponsor information
Hospital/treatment centre
Alexandra House, Cheltenham General Hospital, Sandford Road
Cheltenham
GL53 7AN
England
United Kingdom
| Phone | +44 3004225460 |
|---|---|
| chris.ford1@nhs.net | |
| Website | http://www.gloshospitals.nhs.uk/ |
"ROR" |
https://ror.org/04mw34986 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to submit abstracts for meetings and publish the results of this study in peer reviewed journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request: p.scanlon@nhs.net |
Editorial Notes
12/02/2025: Internal review.
27/11/2024: Trial's existence confirmed by NHS HRA.
