NCT01084850

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

March 11, 2010

Status Verified

January 1, 2010

Enrollment Period

1 year

First QC Date

February 25, 2010

Last Update Submit

March 10, 2010

Conditions

Corneal Dystrophy

Keywords

Corneal endotheliumdiabetes mellituscorneal thickness

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Corneal endothelium morphology

    1 year

Study Arms (2)

Diabetes Type II

Patients with type 2 Diabetes Mellitus

Control

Patients with no diabetes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients visiting Frederiksberg hospital for any reason

You may qualify if:

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

You may not qualify if:

  • Glaucoma
  • Uveitis (current or previous)
  • Corneal scaring
  • Previous eye surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frederiksberg University Eye Clinque

Frederiksberg, Frederiksberg, 2000, Denmark

RECRUITING

MeSH Terms

Conditions

Corneal Dystrophies, HereditaryDiabetes Mellitus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jens C Norregaard, MD, phd

    Frederiksberg University Hospital, Eye Clinque

    STUDY CHAIR

Central Study Contacts

Allan Storr-Paulsen, MD

CONTACT

+4538163646allanstorr@dadlnet.dk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2010

First Posted

March 11, 2010

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

September 1, 2010

Last Updated

March 11, 2010

Record last verified: 2010-01

Locations

DK(1)