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Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects

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ClinicalTrials.gov Identifier: NCT01084850
Recruitment Status : Unknown
Verified January 2010 by Frederiksberg University Hospital.
Recruitment status was:  Recruiting
First Posted : March 11, 2010
Last Update Posted : March 11, 2010
Sponsor:
Information provided by:
Frederiksberg University Hospital

Study Description
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Brief Summary:
The purpose of this study is to compare corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with special reference to glycemic status.

Condition or disease
Corneal Dystrophy

Detailed Description:
Diabetes might influence the health of the corneal endothelium. Older studies have presented different results and the glycemic status of the patients have not been reported. In this study we examine the corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with modern specular microscopy. Each patient and control is examined once ("entry to study").
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects
Study Start Date : June 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : September 2010

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Groups and Cohorts
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Group/Cohort
Diabetes Type II
Patients with type 2 Diabetes Mellitus
Control
Patients with no diabetes


Outcome Measures
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Primary Outcome Measures :
  1. Corneal endothelium cell number [ Time Frame: 1 year ]
    The study is a cross-sectional study. We compare a cohort of patients with DM to a cohort with no DM. We examine each patient and control once. We call time of appointment or examination for "at entry to study".


Secondary Outcome Measures :
  1. Corneal endothelium morphology [ Time Frame: 1 year ]
    The size and hexagonality of the cells are analysed automaticly by computer recognizion.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients visiting Frederiksberg hospital for any reason
Criteria

Inclusion Criteria:

  • Type II diabetes (diagnose confirmed by general practitioner)
  • Controls with no diabetes (confirmed by blood testing).

Exclusion Criteria:

  • Glaucoma
  • Uveitis (current or previous)
  • Corneal scaring
  • Previous eye surgery
Contacts and Locations
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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): NCT01084850


Contacts
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Contact: Allan Storr-Paulsen, MD +4538163646 allanstorr@dadlnet.dk

Locations
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Denmark
Frederiksberg University Eye Clinque Recruiting
Frederiksberg, Denmark, 2000
Contact: Allan Storr-Paulsen, MD    +4538163646    allanstorr@dadlnet.dk   
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
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Study Chair: Jens C Norregaard, MD, phd Frederiksberg University Hospital, Eye Clinque
More Information
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Responsible Party: Jens christian Norregaard/Head of Department, Frederiksberg Hospital
ClinicalTrials.gov Identifier: NCT01084850    
Other Study ID Numbers: FH5
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: March 11, 2010
Last Verified: January 2010
Keywords provided by Frederiksberg University Hospital:
Corneal endothelium
diabetes mellitus
corneal thickness
Additional relevant MeSH terms:
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Corneal Dystrophies, Hereditary
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn