Corneal Nerve Fiber Changes as a Biomarker for Diabetic Nerve Damage

The LANDMARK study has confirmed previous findings that changes to the nerves in the cornea of the eye may reflect changes in peripheral nerves and indicate the presence of peripheral nerve damage. Corneal nerves can be imaged non-invasively using confocal microscopy. The current paper finds that changes in corneal nerve fibers, such as decreased length of fibers, correlate with the presence of peripheral nerve damage in trial subjects with T1D.


Utility of corneal confocal microscopy for assessing mild diabetic neuropathy: baseline findings of the LANDMARK study. Clin Exp Optom. 2012 May;95(3):348-54. Edwards K, Pritchard N, Vagenas D, Russell A, Malik RA, Efron N.

Investigators and Institutions:

Dr. Nathan Efron, Queensland University of Technology, Rayaz Malik, University of Manchester and colleagues.

Ramifications for Individuals with Type 1 Diabetes:

Peripheral nerve damage can lead to numbness, pain and contribute to non-healing ulcers and the need for amputation in those with diabetes. There are currently no disease-modifying therapies. Current tests to detect and stage peripheral nerve damage such as measurement of nerve conduction speed can be complex, invasive or not very sensitive to change. More sensitive techniques and biomarkers could help earlier detection of diabetic nerve damage and might even be used in clinical trials to detect effects of therapy to treat diabetic peripheral nerve damage. Previous clinical trials for therapies to treat diabetic peripheral nerve damage have been of substantial length and with complex endpoints. Biomarkers that could detect a therapeutic effect earlier in a trial could help to de-risk the development pathway for companies developing new therapies in this area.

JDRF Involvement:

JDRF funds the LANDMARK study through a milestone-managed clinical award (PI: Dr. Nathan Efron). JDRF also coordinates a group of international, collaborating investigators working on different aspects of validation of this biomarker and to develop software to assist in more rapidly analyzing images of corneal nerve fibers which would be essential for more widespread use of this biomarker.