UWF-SEND
Research type
Research Study
Full title
The implementation of Ultra-widefield/Optical Coherence Tomography imaging clinics as a method of referral refinement in reducing unnecessary Hospital Eye Service referrals from the Diabetic Eye Screening Programme
IRAS ID
287889
Contact name
Adam Wilson
Contact email
Sponsor organisation
Optos Plc
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 4 days
Research summary
NHS patients with Diabetes are regularly screened for eye diseases through the Diabetic Eye Screening Programme (DESP). This service looks at the images of the back of the eye (retinal images), and records the level of eye disease present. Patients with retinal images that require a review by a specialist doctor at the hospital, are referred from the DESP to the Hospital Eye Services (HES).
All patients referred from DESP to HES with non-urgent referrals, will be invited to take part in the study. The aim is to recruit around 1,200 participants at 3 hospitals in the UK.
The study consists of 1 study visit that may last up to 1 hour and will take place on the same day as your regular scheduled HES appointment.
The retinal imaging devices used in this study are CE marked, which means they are already approved for medical use in the UK/Europe and have been proven to be safe for retinal imaging.
The purpose of the main study (OPT1051) is to try and find out if having extra retinal images could reduce the number of patients who need a HES appointment.
Participants in the main study (OPT 1051) will be invited to take part in a sub-study (OPT 1050). The purpose of this sub-study is to follow (for up to 3 years) patients who have been sent to the local digital surveillance clinic (instead of HES), to see if they have stayed there or have been sent back to HES. This will involve study staff looking at participant's medical records every 6 months to see if they are still being cared for by the local digital surveillance clinic or by HES.
This data will help us understand the number of patients who stay in the local digital surveillance clinic and the costs involved.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0212
Date of REC Opinion
14 Sep 2021
REC opinion
Further Information Favourable Opinion