Sensitivity and specificity of corneal microscopy in polyneuropathy
Research type
Research Study
Full title
Sensitivity and specificity of corneal confocal microscopy in painless and painful polyneuropathy (SeCoM) - Part of the Europain Collaboration
IRAS ID
159790
Contact name
Becky Ward
Contact email
Sponsor organisation
Imperial College
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Corneal Confocal Microscopy (CCM) is a new, non-invasive tool to assess nerve fibre loss at an early stage of diseases affecting small nerve fibres, such as diabetic neuropathy. It also offers a way to non-invasively follow the disease process and any response to treatment. Currently the only other reliable ways to do this are by taking an invasive skin biopsy or by complicated sensory testing.
There is minimal data on how corneal nerve fibres change with age in healthy subjects. There is also limited information about the observer and re-retest reliability of CCM, so initially healthy volunteers will be recruited to assess this prior to the recruitment of patients.
CCM has been proven to be a sensitive way of measuring fibre loss in diabetic neuropathy which has several similarities to HIV associated neuropathy. This would be the first study to examine corneal images in HIV patients to identify nerve loss. Studies have also been conducted in animal models of HIV where corneal nerve fibre density has been shown to correlate to nerve fibre density in the skin. Therefore in this study we aim to identify whether there is a similar correlation between CCM images and skin biopsies in humans.
The study will be conducted in conjunction with sites in Bochum, Mannheim and Kiel in Germany and Aarhus, Denmark and image capture and analysis in the UK will be conducted at Moorfields Eye Hospital, London.
Patients and healthy volunteers will undergo CCM, a quick, non-invasive procedure to take a photograph of the front of their eye. They will be asked to complete questionnaires, undergo sensory testing, a clinical examination and two small skin biopsies, under local anaesthetic.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/0559
Date of REC Opinion
16 Apr 2015
REC opinion
Further Information Favourable Opinion