Evaluation of Corneal Confocal Microscopy for the Identification and Prediction of Neuropathy in Type 1 Diabetes

CompletedOBSERVATIONAL
Enrollment

624

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2018

Conditions
Diabetic PolyneuropathyDiabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes Complications
Interventions
OTHER

Exposure: Corneal nerve fibre morphology by the CCM Procedure

"CCM is a non-invasive method for direct visualization of corneal nerve fibers. Previous research work has confirmed that corneal nerves status correlates with both small and large fibre damage as assessed by quantitative sensory testing and nerve conduction.~In the current trial subjects will undergo a bilateral examination of the Bowman's layer of the cornea using the Rostock Cornea Module of the Heidelberg Tomograph III (Heidelberg Engineering, Smithfield RI, USA) to determine their corneal nerve fiber length, corneal nerve fiber density, corneal nerve branch density, and the tortuosity coefficient. Topical anaesthetic and a viscous gel medium will be applied to the eye, which will create a visual gel bridge between the cornea and the sterile single-use cap on the microscope objective lens. After the interface between the corneal epithelium and Bowman's layer is identified, batches of images will be taken and the most technically sound images will be identified and analyzed."

Trial Locations (5)

4059

Queensland University of Technology, Brisbane

48105

University of Michigan, Ann Arbor

T3B6A8

University of Calgary, Calgary

M5G 2C4

Mount Sinai Hospital and University Health Network, Toronto

M139PT

University of Manchester, Manchester

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

University of Calgary

OTHER

collaborator

Queensland University of Technology

OTHER

collaborator

University of Michigan

OTHER

collaborator

University of Manchester

OTHER

lead

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

NCT02423434 - Evaluation of Corneal Confocal Microscopy for the Identification and Prediction of Neuropathy in Type 1 Diabetes | Biotech Hunter | Biotech Hunter