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

March 10, 2010 updated by: Frederiksberg University Hospital
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • Recruiting
        • Frederiksberg University Eye Clinque
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients visiting Frederiksberg hospital for any reason

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal endothelium morphology
Time Frame: 1 year
The size and hexagonality of the cells are analysed automaticly by computer recognizion.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frederiksberg University Hospital

Investigators

  • Study Chair: Jens C Norregaard, MD, phd, Frederiksberg University Hospital, Eye Clinque

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

March 10, 2010

First Posted (Estimate)

March 11, 2010

Study Record Updates

Last Update Posted (Estimate)

March 11, 2010

Last Update Submitted That Met QC Criteria

March 10, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FH5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Corneal Dystrophy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe