EYE-SCREEN-4-DPN
Research type
Research Study
Full title
Development of an innovative intelligent EYE imaging solution for SCREENing of Diabetic Peripheral Neuropathy
IRAS ID
365672
Contact name
Uazman Alam
Contact email
Sponsor organisation
University of Liverpool
ISRCTN Number
ISRCTN12967700
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes. High blood sugar over time can damage the nerves, usually associated with changes in sensation or pain in the feet and hands. DPN is often only diagnosed once symptoms have become noticeable, and current tests look mainly at large nerve fibres or require invasive procedures such as skin biopsies. This means early nerve damage can be missed. There is a need for a simple, accurate and practical way to detect DPN earlier so treatment can start sooner and prevent further complications.
The cornea, the clear curved surface at the front of the eye, contains small nerves. Research has shown that these nerves begin to change in early stages of DPN - even before symptoms appear - when using a technique called corneal confocal microscopy (CCM). However, CCM involves touching the eye with a camera for several minutes, which can be uncomfortable and is not suitable for everyone, especially for screening large numbers of people.
This study will test a new, contact-free eye imaging device called an optical coherence microscope, which can capture detailed images of corneal nerves without touching the eye. After an initial usability study with healthy volunteers, we will invite participants into phase 1 and 2 clinical studies to assess how well the new device works.
This device will also be integrated with artificial intelligence (AI), which can automatically analyse the images to detect signs of DPN. By combining quick, comfortable eye scanning with automated image analysis, this approach may offer a modern and widely accessible way to screen for DPN early.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
26/NW/0060
Date of REC Opinion
20 Mar 2026
REC opinion
Favourable Opinion