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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01084850

Enrollment

300

Registered

2010-03-11

Start date

2009-06-30

Completion date

2010-09-30

Last updated

2010-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Dystrophy

Keywords

Corneal endothelium, diabetes mellitus, corneal thickness

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.

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Corneal endothelium cell number	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.

Secondary

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

Countries

Denmark

Contacts

Primary ContactAllan Storr-Paulsen, MD

allanstorr@dadlnet.dk+4538163646

Outcome results