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

Corneal Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01084850
• Other study ID #: FH5
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2010
• Last updated: March 10, 2010
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: January 2010
• Source: Frederiksberg University Hospital
• Contact: Allan Storr-Paulsen, MD
• Phone: +4538163646
• Email: allanstorr[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

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").

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Corneal Dystrophy
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Denmark	Frederiksberg University Eye Clinque	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal endothelium cell number	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".	1 year	No
Secondary	Corneal endothelium morphology	The size and hexagonality of the cells are analysed automaticly by computer recognizion.	1 year	No