Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000058077
Ethics application status
Approved
Date submitted
3/12/2009
Date registered
19/01/2010
Date last updated
9/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Corneal nerve microstructure in Diabetes Mellitus
Scientific title
Correlation of corneal nerve microstructure and function with peripheral neuropathy in Type I Diabetes Mellitus
Secondary ID [1] 294547 0
Auckland District Health Board: A+ 4611
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type I Diabetes Mellitus 252324 0
Condition category
Condition code
Metabolic and Endocrine 252510 252510 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 255628 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253411 0
To quantify changes in corneal innervation, thickness, epithelium, keratocyte density and endothelium, and correlate these with the severity of peripheral diabetic neuropathy and retinopathy.

Techniques will include in vivo confocal microscopy of the cornea to measure epithelium, keratocyte and endothelium density, corneal thickness measurement by computerised corneal topography, assessment of corneal sensation by aesthesiometry. Corneal data will be compared with a cohort of 40 age-matched controls, who have no history of corneal disease, diabetes, or neurological disease. Within the diabetic group, data will be correlated with the stage of peripheral neuropathy as characterised by a standardised neuropathy questionnaire and clinical examination graded by the Neuropathy Disability Score.
Timepoint [1] 253411 0
140 participants will be assessed within a period of 24 months. Each participant will require only one visit.
Primary outcome [2] 253412 0
To qualitatively compare corneal nerve pattern in the normal, Type I diabetic cornea.
Technique will include in vivo confocal microscopy of the cornea to obtain images of corneal nerves. The images will be arranged to form a contiguous montage of corneal nerve pattern.
Timepoint [2] 253412 0
20 participants will undergo this assessment within a period of 6 months. Each participant will require only one visit.
Secondary outcome [1] 262519 0
To evaluate tear film abnormalities in the diabetic eye.
Tear film Symptomatology will be assessed by McMonnies Dry Eye Questionnaire, Tear film stability by Tearscope Plus (Keeler) and Tear production by phenol red thread test.
The tear film data will be compared with a cohort of 40 age-matched controls, who have no history of corneal disease, diabetes, or neurological disease. Within the diabetic group, data will be correlated with the stage of peripheral neuropathy as characterised by a standardised neuropathy questionnaire and clinical examination graded by the Neuropathy Disability Score.
Timepoint [1] 262519 0
140 participants will be assessed within a period of 24 months. Each participant will require only one visit.

Eligibility
Key inclusion criteria
Type I Diabetes Mellitus
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/01/2010
Actual
20/03/2010
Date of last participant enrolment
Anticipated
Actual
28/02/2018
Date of last data collection
Anticipated
Actual
28/02/2018
Sample size
Target
140
Accrual to date
Final
138
Recruitment outside Australia
Country [1] 2350 0
New Zealand
State/province [1] 2350 0
Auckland

Funding & Sponsors
Funding source category [1] 256130 0
University
Name [1] 256130 0
University of Auckland Doctoral Scholarship
Country [1] 256130 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland,
Private Bag 92019,
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 251471 0
None
Name [1] 251471 0
Address [1] 251471 0
Country [1] 251471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258219 0
Northern X Regional Ethics Committee
Ethics committee address [1] 258219 0
Ethics Committees
Health & Disability Services Policy Group
Population Health Directorate
Ministry of Health
09 580 9105
09 580 9001
Ethics committee country [1] 258219 0
Date submitted for ethics approval [1] 258219 0
20/11/2009
Approval date [1] 258219 0
16/03/2010
Ethics approval number [1] 258219 0
NTX/09/12/122

Summary
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.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30567 0
Dr Stuti Misra
Address 30567 0
Department of Ophthalmology, Faculty of Medical & Health Science University of Auckland, Private bag 92019 Auckland 1142
Country 30567 0
New Zealand
Phone 30567 0
+6499236582
Fax 30567 0
Email 30567 0
[email protected]
Contact person for public queries
Name 13814 0
Stuti Misra
Address 13814 0
Department of Ophthalmology,
Faculty of Medical & Health Science
University of Auckland,
Private bag 92019
Auckland 1142
Country 13814 0
New Zealand
Phone 13814 0
+64 9 923 6582
Fax 13814 0
+64 9 367 7173
Email 13814 0
[email protected]
Contact person for scientific queries
Name 4742 0
Dr. Jennifer Craig
Address 4742 0
Department of Ophthalmology,
Faculty of Medical & Health Science
University of Auckland,
Private bag 92019
Auckland 1142
Country 4742 0
New Zealand
Phone 4742 0
+64 9 923 8173
Fax 4742 0
+64 9 367 7173
Email 4742 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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