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Corneal nerve microstructure in Diabetes Mellitus

Correlation of corneal nerve microstructure and function with peripheral neuropathy in Type I Diabetes Mellitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12610000058077
Enrollment
138
Registered
2010-01-19
Start date
2010-03-20
Completion date
2018-02-28
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Diabetic neuropathy involves changes to peripheral somatic and autonomic innervation, as well as quantifiable changes to cranial nerves and the central nervous system. Corneal innervation provides important protective and trophic functions and its interruption may result in impaired cell attachment, altered epithelial structure, decreased mitotic rate, increased permeability, poor tear film and delayed wound healing. Reduced corneal sensation, observed in 70% of diabetics compared with 10% of controls, has been shown to be associated with duration of diabetic disease and correlates strongly with stage of peripheral neuropathy. We hypothesise that changes in corneal innervation, as imaged by in vivo confocal microscopy and assessed by aesthesiometry, will correlate with the stage of peripheral diabetic neuropathy, offering future potential for assessing nerve structure in vivo, without the need for nerve biopsy.

Interventions

Observational study. The changes in corneal innervation, thickness, epithelium, keratocyte density and endothelium will be observed in 100 participants with diabetic cornea and 40 age matched participants with normal cornea without any history of diabetes or corneal disorders. These will be correlated with the severity of peripheral diabetic neuropathy and retinopathy. The corneal nerve pattern will also be observed in both normal and diabetic cornea. The duration of the project is 3 years.

Sponsors

University of Auckland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

Type I Diabetes Mellitus

Exclusion criteria

History of contact lens wear ocular disease or ocular surgery use of preservative topical medications Any other known cause of neuropathy Any clinical evidence of significant corneal abnormality.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026