Hemel Hempstead, UK – Diabetic neuropathy – the most common and costly complication of diabetes leading to foot ulceration and amputation in severe cases – is the subject of a major international ocular research project at the University of Manchester.
The £200k, six month project, has significant implications as nerve fibre damage is typically assessed through invasive tests, including nerve and skin biopsies. Screening for diabetic nerve damage via corneal nerves is being sponsored by Heidelberg Engineering, with clinicians using the HRT3 with Rostock Corneal Module advanced screening technology.
The study of patients with diabetic eye disease – from four very diverse areas of Greater Manchester – will show the value of early neuropathy screening believes the lead researcher, Dr Mitra Tavakoli, optometrist and research fellow at the University’s Centre for Endocrinology and Diabetes.
“Early identification of neuropathy enables earlier treatment to control progression of this serious and life-limiting condition. Corneal confocal microscopy (CCM) is an established diagnostic tool used in a variety of other clinical applications. This relatively novel eye test is non-invasive and quick to administer, making it an ideal method to study the cornea as a sensitive alternative marker to detect diabetic neuropathy early,” believes Dr Tavakoli.
Jointly funded by Heidelberg Engineering and the CLAHRC-GM National Institute for Health Research, the study will be conducted at four primary care optometry practices across Greater Manchester. The areas selected for assessment reflect the diverse genetic and social demographical mix that includes the most opulent and the most deprived communities of Harpurhey, Hulme, Urmston, Altrincham – will each monitor 100 patients with diabetic eye disease. The novel and important project aims to assess the feasibility and acceptability of implementing this new technology in community optometry practices alongside routine diabetic retinopathy screening.
As a leading centre for the past twelve years in the establishment of corneal confocal microscopy for the early detection of diabetic neuropathy, Manchester was a natural choice to conduct the study. Translating research into clinical practice is the aim, with a combined cost-of-illness and budget impact analysis. This will provide an assessment of the likely impact that routine screening would have on healthcare budgets.
“This study forms part of a wider, long term, programme of work which aims to consider whether early assessment of diabetic neuropathy using CCM would be appropriate to adopt as a national screening programme. The major clinical impact of this work is that the most costly and serious complication of diabetes – namely neuropathy which results in foot ulceration and amputation – could be identified to allow earlier treatment and prevention,” added Dr Tavakoli.
It is possible that following the study, all people with diabetes mellitus could undergo regular screening for diabetic neuropathy alongside their retinopathy screening. People with existing early-stage neuropathy, or at risk of this, will be able to access treatment early, preventing progression of this damage.
“We have a very successful, long established, retinopathy screening programme in England and this reflects the fact that the UK has the world’s lowest incidence of blindness caused by diabetes. We believe that the Early Neuropathy Assessment Group is set to take this to the next level. Our fellow healthcare clinicians around the world are watching the study with great interest as this screening negates the need for invasive and painful nerve biopsies, as a basis to intervene with treatment,” said Dr Tavakoli.
“In the future we expect High Street opticians to be performing this screening for both retinopathy and neuropathy and to share this data with General Practitioners. Currently only the Heidelberg Engineering technology is sensitive enough to monitor these minute changes,” she added.