Methods for evaluation of corneal nerve fibres in diabetes mellitus by in vivo confocal microscopy: a scoping review protocol

INTRODUCTION: Globally, 422 million people have diabetes. Late complications of diabetes are blindness, kidney failure, heart attack, stroke and lower limb amputation. The prevalence of diabetic peripheral neuropathy and diabetic retinopathy is 50% and 35%, respectively. In vivo confocal microscopy (IVCM) is a rapid, non-invasive method to evaluate subbasal corneal nerve fibres, which are small fibres of the peripheral nervous system. Corneal nerve fibre changes can be a marker of diabetic peripheral neuropathy. There is currently no gold-standard procedure for IVCM imaging, image processing or quantitative analysis of the corneal nerve fibres in the subbasal plexus. This protocol describes a scoping review to map, summarise and critically evaluate current methods used with IVCM evaluation in people with diabetes mellitus. METHODS: The scoping review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for scoping review. A comprehensive search of the literature will be conducted in MEDLINE, Embase, Cochrane, Scopus and Web of Science. The search strategy will include terms related to IVCM, diabetes and corneal nerve fibres. We will set inclusion and exclusion criteria prior to the search, and two reviewers will screen titles and abstracts independently. One reviewer will full text read eligible articles and chart data from the studies. A descriptive summary of the methods used in imaging, image processing and quantitative analysis of peripheral corneal nerve fibres by IVCM will be written. ETHICS AND DISSEMINATION: Ethical approval is not required since this is a scoping review based on previously published articles. The findings will be published in a scientific peer-reviewed journal.