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Status unknownNCT01084850Updated Mar 11, 2010

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

An observational study in Corneal Dystrophy, sponsored by Frederiksberg University Hospital. Status unknown at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2010-03-11.

Sponsored by Frederiksberg University Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
300
Sex
All
01

Study 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.

Read the 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").

02

Conditions studied

  • Corneal Dystrophy

Keywords

  • Corneal endothelium
  • diabetes mellitus
  • corneal thickness
03

In context

Corneal Dystrophies, Hereditary

58 studies on the registry are indexed under Corneal Dystrophies, Hereditary; 11 are open to participants now.

This study's planned enrollment of 300 is above the median of 213 across 20 observational studies indexed under Corneal Dystrophies, Hereditary.

Browse Corneal Dystrophies, Hereditary studies →

Lead sponsor

Frederiksberg University Hospital is the lead sponsor of 40 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients visiting Frederiksberg hospital for any reason

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Glaucoma
  • Uveitis (current or previous)
  • Corneal scaring
  • Previous eye surgery
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)

Groups and cohorts

  • Diabetes Type II

    Patients with type 2 Diabetes Mellitus

  • Control

    Patients with no diabetes

06

What researchers measure

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".

    Time frame: 1 year

Secondary outcomes

  1. Corneal endothelium morphology

    The size and hexagonality of the cells are analysed automaticly by computer recognizion.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Frederiksberg University Eye Clinque
    Frederiksberg, 2000, Denmark
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01084850
Lead sponsor
Frederiksberg University Hospital
First posted
Mar 11, 2010
Start date
Jun 2009
Primary completion
Jun 2010 (estimated)
Completion
Sep 2010 (estimated)
Last update
Mar 11, 2010

Study contacts

Allan Storr-Paulsen, MD
Contact
allanstorr@dadlnet.dk
+4538163646
Jens C Norregaard, MD, phd
study chair · Frederiksberg University Hospital, Eye Clinque

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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