Development of an innovative intelligent EYE imaging solution for SCREENing of diabetic peripheral neuropathy
Diabetes mellitus, polyneuropathies and other disorders of the peripheral nervous system
(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 cross-sectional clinical study - 54 healthy volunteer participants and 116 patients with diabetes. For the usability study, healthy volunteers will undergo imaging with the novel OCM device at the University of Liverpool. These volunteers will be recruited from the University of Liverpool, from health friends and family of patients at Aintree University Hospital of NHS University Hospitals of Liverpool Group. For the phase 1 longitudinal study, 50 participants with diabetes and healthy age-gender matched volunteers will undergo routine diabetes-related blood and urine tests, standard-of-care clinical neuropathy tests, clinical questionnaires, autonomic neuropathy testing, corneal confocal microscope and the novel OCM. These participants will be followed up at 9-12 months to undergo the same tests from baseline. For the phase 2 cross-sectional study, 54 healthy volunteers and 116 patients with diabetes will also undergo routine diabetes-related blood and urine tests, standard-of-care clinical neuropathy tests, clinical questionnaires, autonomic neuropathy testing, corneal confocal microscope and the novel OCM. For reproducibility, 10 participants among the 54 healthy volunteers and 20 from the 116 diabetic patients in the phase 2 cross-sectional study will be rescanned with the novel OCM only after 2-6 weeks. Each visit in the clinical studies will include: - Obtaining consent, reviewing medical history and concomitant medications - Height, weight, resting heart rate and blood pressure - Blood and urine tests - Neurological examination with monofilament testing and vibration perception threshold - Clinical questionnaires (Michigan Neuropathy Screening Instrument, Neuropathy Symptom Profile, painDETECT) - Nerve conduction studies - Autonomic neuropathy assessment (usi
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
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