Corneal Confocal Microscopy: A multinational study
Research type
Research Study
Full title
Evaluation of corneal confocal microscopy as a surrogate endpoint for the identification and prediction of diabetic neuropathy (multinational study)
IRAS ID
197851
Contact name
Andrew J Boulton
Contact email
Sponsor organisation
The university of Manchester
Duration of Study in the UK
1 years, 6 months, 28 days
Research summary
Research Summary
Peripheral neuropathy develops when nerves in the body’s extremities – such as the hands, feet and arms – are damaged. Diabetic peripheral neuropathy is a significant clinical problem that currently has no effective therapy, and in advanced cases, it is a major cause of morbidity and mortality worldwide. Furthermore, management of this condition places a major economic burden on the health care system. The accurate detection, characterization and quantification of this condition are important to define at risk patients, anticipate deterioration, monitor progression and assess new therapies. There is thus a fundamental need to establish a diagnostic test that can accurately diagnose, predict onset, and assess progression of nerve damage. We previously showed that the measurement of nerve morphology parameters in the cornea, the transparent front part of the eye, using in-vivo corneal confocal microscopy (CCM) represents an accurate diagnostic test of diabetic neuropathy in patients with type 1 and type 2 diabetes. \nImportantly, this procedure could be arranged with the annual eye examination for retinopathy (damage to the back of the eye), a part of current clinical practice. Results of our study will unequivocally determine the role of CCM as a method to determine future risk of neuropathy allowing clinicians to risk stratify their patients. Finally, CCM has the potential to be used in diagnosing the onset, severity and progression of peripheral neuropathy and may prove to be a valid diagnostic test for use in the clinical trials designed to identify disease-modifying interventions.
Summary of Results
Lay summary of study results: Significant reduction was observed in corneal nerve parameters - corneal nerve fibre density (CNFD), branch density (CNBD) and length (CNFL) - in patients with type 1 and type 2 diabetes compared to healthy controls. Furthermore, corneal nerve fibre parameters were signficantly lower in type 1 compared to type 2 diabetes.
Multivariate regression analysis revealed that age, HbA1c and weight contribute to a reduction in CNFL in patients with type 2 diabetes and duration of diabetes, LDL cholesterol and triglycerides contribute to a reduction in CNFL in patients with type 1 diabetes.
Corneal confocal microscopy provides good diagnostic accuracy for diabetic peripheral neuropathyREC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0729
Date of REC Opinion
11 Nov 2016
REC opinion
Further Information Favourable Opinion