Evaluation of Corneal Confocal Microscopy for the Identification and Prediction of Neuropathy in Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT02423434|
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : November 6, 2019
Through the multinational pooled dataset approach, this trial will aim to derive and validate specific in vivo Corneal Confocal Microscopy (CCM) parameter thresholds for the identification of diabetic polyneuropathy, and - more importantly - the identification of individuals at future risk. Results of the study will permit application in clinical practice and intervention trials for diabetic polyneuropathy (DPN) risk stratification.
The primary goal of the study is to re-examine individuals with type 1 and type 2 diabetes with and without neuropathy, who had CCM performed in the past as a part of their neurological examination, to assess concurrent and predictive validity of different CCM parameters in individuals . These subjects will be invited to the study to be re-examined by CCM along with other neurological tests (physical exam, nerve conduction studies, quantitative sensory testing, blood test and in some centres also skin biopsy) during the single study visit. Additionally CCM data will be analyzed both manually and by recently developed automated analytical software to evaluate accuracy of the automated method. Evaluation of automated image analysis will influence likelihood of successful knowledge translation of this surrogate biomarker for DPN into clinical practice - in which the procedure could be harmonized with annual retinal examinations - and into intervention trials.
Secondary aim of the study is to determine the factors associated with CCM parameters and their longitudinal change and collect bio-samples for future research in this field.
|Condition or disease||Intervention/treatment|
|Diabetic Polyneuropathy Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Complications||Other: Exposure: Corneal nerve fibre morphology by the CCM Procedure|
|Study Type :||Observational|
|Actual Enrollment :||624 participants|
|Official Title:||Multinational Collaborative Evaluation of Corneal Confocal Microscopy as a Surrogate Endpoint for the Identification and Prediction of Diabetic Neuropathy in Type 1 Diabetes|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
|Corneal Confocal Microscopy subjects||
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.
- Evaluate the Concurrent Validity of CCM Parameters from Cross-Sectional Analysis of Well-Characterized T1D and T2D Subjects. [ Time Frame: Any data obtained from pre-study measurements ]
- Evaluate the Predictive Validity of CCM Parameters based on the 5-7 year Incidence of Neuropathy in Well-Characterized T1D and T2D Subjects Without Neuropathy at Baseline [ Time Frame: Study visit ]
- Evaluate the Predictive Validity of CCM Parameters for 5-7 year Progression of Neuropathy [ Time Frame: Study visit ]
- Comparison of Manual versus Automated Image analysis [ Time Frame: Pre-study and study visit data ]
- Determination of the Factors associated with CCM Parameters and their Longitudinal Change [ Time Frame: Study visit ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423434
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48105|
|Queensland University of Technology|
|Brisbane, Australia, 4059|
|University of Calgary|
|Calgary, Alberta, Canada, T3B6A8|
|Mount Sinai Hospital and University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|University of Manchester|
|Manchester, United Kingdom, M139PT|
|Principal Investigator:||Bruce A Perkins, MD||MOUNT SINAI HOSPITAL|