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
| ISRCTN | ISRCTN16254044 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16254044 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 297725 |
| Protocol serial number | 9j 07/04/2021, IRAS 297725, CPMS 49321 |
| Sponsor | Gloucestershire Hospitals NHS Foundation Trust |
| Funders | Innovate UK, Optos Ltd, Centre Vue, RetinaScan Ltd |
- Submission date
- 15/06/2021
- Registration date
- 14/09/2021
- Last edited
- 11/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Diabetes affects 4.7 million people in the UK. A common complication is diabetic retinopathy (DR), where there is damage to the blood vessels in the eye. Screening for early detection of DR has contributed to reducing blindness due to diabetes in the UK. This is carried out each year by using photography of the back of the eye (the retina). In England and Wales, the pupils are dilated with eye drops and then two 45-degree photographs of each eye are taken which gives a combined photographic width of 60 degrees of retina.
Scanning confocal ophthalmoscopes (SCO) are cameras that use low-powered laser or LED light to scan across the retina without the need for a bright flash and the width of one photograph varies from 60 - 200 degrees. This means only one photo of each eye is needed and pupil dilation may not be required. This would be an advantage as pupil dilation takes time, can be uncomfortable, and blurs the vision for several hours, meaning most people need to be accompanied to screening appointments and can’t drive afterwards. Better accuracy, shorter appointment times, and the elimination of eye drops could increase the number of people who attend eye screening and DR could be caught earlier which may reduce the risk of vision loss.
At present, it is unknown whether white light LED or laser light is better for detection of DR, or if a wider photo might pick up more pathology in the wider retina but may pick up less in the centre. Both might have an effect on referral to hospital eye clinics (HEC). This study will assess the accuracy of two new cameras when screening for any eye disease caused by diabetes to find out whether the new cameras are as good as the current system or offer improved detection.
Who can participate?
Patients with diabetes who meet the inclusion criteria for the National Diabetes Eye Screening Programme in the UK. These will be people with diabetes over the age of 12 years (except for those under 16 years attending their first screening appointment)
What does the study involve?
The researchers will use some data from another similar study where people attending their routine screening appointment were asked to have one extra photograph taken of each eye by each of the cameras before pupil dilation, followed by the normal screening procedure. If the image quality was poor they were asked to have a further photograph taken of each eye with the new cameras after their pupils were dilated. The researchers will collect additional images in the same way from a second group of patients who will have one extra image of each eye taken with a third camera. The information from the images will be combined to see which camera provides the best photographs for screening. Participants will be asked for their opinion on having their eyes examined on the existing and new cameras. This is a single appointment visit and no study follow up is required.
What are the possible benefits and risks of participating?
There are no anticipated risks of taking part in the study or any direct benefits to the participants. The benefits may be in the future if these devices are considered an improvement and are adopted into the National Screening Programme. The extra images will add an extra 30 minutes to a participant’s appointment time but this was felt to be acceptable providing clear information is given and extra parking costs are reimbursed.
Where is the study run from?
Gloucestershire Hospitals NHS Foundation Trust (UK)
When will the study take place?
October 2020 to May 2023
Who is funding the study?
1. Innovate UK
2. Optos UK
3. Centre Vue (UK)
4. RetinaScan Ltd (UK)
Who is the main contact?
Prof. Peter Scanlon
p.scanlon@nhs.net
Contact information
Scientific
GRRG Office, above Oakley Ward
Cheltenham General Hospital
Cheltenham
GL53 7AN
United Kingdom
 ORCID ID |
0000-0001-8513-710X |
|---|---|
| Phone | +44 (0)3004222851 |
| p.scanlon@nhs.net |
Public
The Orchard Centre
Gloucestershire Royal Hospital
Great Western road
Gloucester
GL1 3NN
United Kingdom
| Phone | +44 (0)3004223853 |
|---|---|
| laura.lodge1@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre diagnostic accuracy study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Scanning CONfocal Ophthalmoscopy foR DIAbetic eye screening |
| Study acronym | CONCORDIA 1 |
| Study objectives | To assess the sensitivity and specificity of retinal images taken using the Optos California and the Zeiss Clarus or the CentreVue Eidon scanning ophthalmoscopes with staged mydriasis compared with standard two 45-degree photographs taken following mydriasis as currently used in the English National Diabetic Eye Screening Programme. Also, a health economic study to determine their cost-effectiveness. |
| Ethics approval(s) | Approved 09/08/2021, South West - Cornwall & Plymouth Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8019, +44 (0)207 104 8370, +44 (0)207 104 8071; cornwallandplymouth.rec@hra.nhs.uk), REC ref: 21/SW/0064 |
| Health condition(s) or problem(s) studied | Diabetic eye disease |
| Intervention | The interventions are three different SCO devices that are compared with the standard digital images taken in the English National Screening programme. Work package 1 is using data from two devices (Optos and Clarus) collected in another study (AIDED). The device order was randomised but not concealed for the operator as this isn’t possible. Work package 2 will collect additional data using a third SCO device (Eidon). The duration of participation in the trial is around 30 mins per participant, as they will have additional images taken with the new devices 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 and the EuroQoL EQ5D-5L which is part of the data collection for the health economics element in work package 3. 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Zeiss Clarus with an 88-degree (external) field, Optos California with a 135-degree (external) field, CentreVue Eidon with a 60-degree field (UK supplier Mainline) |
| Primary outcome measure(s) |
Sensitivity and specificity of the Optos, Clarus and Eidon devices 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. All the data are collected at a single timepoint which is at the routine screening appointment. |
| Key secondary outcome measure(s) |
All the data are collected at a single timepoint which is at the routine screening appointment: |
| Completion date | 31/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 867 |
| Key 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 |
| 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 | 01/07/2021 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Orchard Centre
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the Chief Investigator Prof. Peter Scanlon (p.scanlon@nhs.net). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/01/2024: The intention to publish date was changed from 31/12/2023 to 30/09/2024.
11/02/2022: The recruitment end date has been changed from 28/02/2022 to 31/12/2022.
01/10/2021: The CPMS number was added to the protocol/serial no. field.
24/06/2021: Trial's existence confirmed by the Cornwall and Plymouth Research Ethics Committee.
