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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Frederiksberg University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01084850
First received: February 25, 2010
Last updated: March 10, 2010
Last verified: January 2010
History of Changes
  Purpose

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
Corneal Dystrophy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • Corneal endothelium cell number [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Corneal endothelium morphology [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The size and hexagonality of the cells are analysed automaticly by computer recognizion.


Estimated Enrollment: 300
Study Start Date: June 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes Type II
Patients with type 2 Diabetes Mellitus
Control
Patients with no diabetes

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").

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084850

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

Locations
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
Study Chair: Jens C Norregaard, MD, phd Frederiksberg University Hospital, Eye Clinque
  More Information

No publications provided

Responsible Party: Jens christian Norregaard/Head of Department, Frederiksberg Hospital
ClinicalTrials.gov Identifier: NCT01084850     History of Changes
Other Study ID Numbers: FH5
Study First Received: February 25, 2010
Last Updated: March 10, 2010
Health Authority: Denmark: National Board of Health

Keywords provided by Frederiksberg University Hospital:
Corneal endothelium
diabetes mellitus
corneal thickness

Additional relevant MeSH terms:
Corneal Dystrophies, Hereditary
Diabetes Mellitus
Diabetes Mellitus, Type 2
Corneal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Genetic Diseases, Inborn
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013