Diabetes mellitus, polyneuropathies and other disorders of the peripheral nervous system Nutritional, Metabolic, Endocrine
Conditions
Interventions
(i) Usability study - 10 healthy volunteers
(ii) Phase 1 longitudinal clinical study - 50 participants, including patients with diabetes and age- and gender-matched healthy volunteers.
(iii) Phase 2 c
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Diabetes Cohort 1. Male or female aged > = 18 years old 2. Diagnosis of type 1 or type 2 diabetes mellitus documented in medical records or HbA1C > = 48mmol/mol at screening Healthy Volunteer Cohort 1. Male or female aged > = 18 years old 2. No history or presence of any systemic disorders that may affect nerve fibres or cornea
Exclusion criteria
Exclusion criteria: 1. Unable to provide informed consent 2. Previous corneal transplantation or ocular trauma 3. Ocular surgery or laser eye treatment within 12 months before screening visit 4. Presence of non-diabetic neuropathies 5. Presence or history of aphakia 6. Presence or history of epilepsy or photosensitive seizures 7. Active corneal disease – not limited to dry eye disease, keratitis, keratoconus, corneal dystrophies, corneal ulcers, Fuchs’ dystrophy, Sjogren’s-associated dry eye disease 8. Active ocular disease – not limited to herpes zoster ophthalmicus, glaucoma, nystagmus 9. Any contraindication to nerve conduction studies – pacemaker, implanted electronic devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance of the OCM device for detecting diabetic peripheral neuropathy, as defined by the Toronto criteria measured using various collected metrics, including sensitivity, specificity, precision (or positive predictive value), negative predictive value, F1 score and area under the curve, at one time point at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity, and area under the curve of OCM for diagnosing DPN measured using OCM imaging at one time point at baseline;Repeatability and reproducibility of the OCM in terms of corneal nerve parameters in a subset of 30 participants (10 healthy volunteers and 20 patients with diabetes) measured using OCM imaging at baseline and 2-6 weeks;Agreement and correlation between OCM and corneal confocal microscopy using corneal nerve metrics (corneal nerve fibre density, corneal nerve fibre length, corneal nerve branching density and inferior whorl length) measured using OCM imaging and corneal confocal microscopy (CCM) at one time point at baseline;Predictive ability of the OCM for DPN measured using OCM imaging at baseline and 9-12 months;Usability and feasibility of the OCM device in a clinical research setting measured using task performance metrics (completion rate, scan time, error rates), operator reproducibility, image quality measures (signal-to-noise ratio, artefact prevalence), system reliability, and human factors engineering methods, complemented by participant experience questionnaires, structured observations of use-related errors, and qualitative user feedback, at one time point at baseline;Image quality metrics of OCM imaging measured using data collected from OCM imaging at one time point at baseline;Performance of AI-based corneal nerve analysis adapted from CCM to OCM measured using OCM imaging CCM at one time point at baseline | — |
Countries
England, United Kingdom
Contacts
Public ContactUazman;Kevin Alam;Shaji
;
Outcome results
None listed