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

NCT ID: NCT01084850

Last Updated: 2010-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-09-30

Brief Summary

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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

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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").

Conditions

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Corneal Dystrophy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diabetes Type II

Patients with type 2 Diabetes Mellitus

No interventions assigned to this group

Control

Patients with no diabetes

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Frederiksberg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frederiksberg Hospital

Principal Investigators

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Jens C Norregaard, MD, phd

Role: STUDY_CHAIR

Frederiksberg University Hospital, Eye Clinque

Locations

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Frederiksberg University Eye Clinque

Frederiksberg, Frederiksberg, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Allan Storr-Paulsen, MD

Role: CONTACT

+4538163646

Facility Contacts

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Allan Storr-Paulsen, MD

Role: primary

+4538163646

Other Identifiers

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FH5

Identifier Type: -

Identifier Source: org_study_id

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