Implementation of Corneal Confocal Microscopy in Optometry Practices
Research type
Research Study
Full title
Implementation of Corneal Confocal Microscopy in Primary Care Optometry Practices for Screening and Early Assessment of Diabetic Neuropathy: a Feasibility Study.
IRAS ID
149169
Contact name
Mitra Tavakoli
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
15/WA/0055, Wales
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
This study will investigate the feasibility and acceptability of using Corneal Confocal Microscopy (CCM) for the early assessment of lower limb nerve damage. We will evaluate the practical ability of optometrists to capture good enough images to enable CCM tests to be done in clinical practice. We will evaluate patient and provider views of CCM and the type of training/support that optometrists require to capture images of good enough quality for analysis. We will compare how many patients have a positive CCM result (indicating nerve damage) with the diabetic eye test screening result and medical histories.
The CCM procedure will be carried out in four optometry practices across Greater Manchester. The practices will have a variation in number of patients screened over the last 6 months and local population (age, ethnicity, and social-deprivation). Images will be graded for quality, as well as analysed for nerve damage. The training and support needs of optometrists will also be recorded. Patient and optometrist information will be captured using a short questionnaire after each CCM procedure, and optometrists will take part in detailed interviews at the end of the study.
Results will include the percentages on: images of sufficient quality, patients who consent, patient who undertake successful screening. A combined cost-of-illness and budget impact analysis (BIA), will provide an assessment of the likely impact that that CCM screening tests would have on healthcare budgets. We will also assess the impact of early nerve damage diagnosis, treatment and outcomes. This will allow us to produce a cost-effectiveness analysis of the approach in practice. Heidelberg Engineering will also benefit by learning about the implementation of this technology in the community.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
15/EM/0079
Date of REC Opinion
26 Feb 2015
REC opinion
Further Information Favourable Opinion