Corneal Endothelium Morphology and Central Thickness in T... | NCT01084850

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

NCT01084850

Sponsor

Frederiksberg University Hospital

Status

Unknown status

Last Update Posted

Mar 11, 2010Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Corneal Dystrophy

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jun 2010Estimated

Completion Date

Sep 2010Estimated

First Submitted Date

Feb 25, 2010

First Submission Date that Met QC Criteria

Mar 10, 2010

First Posted Date

Mar 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2010

Last Update Posted Date

Mar 11, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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").

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetes Type II		Patients with type 2 Diabetes Mellitus
Control		Patients with no diabetes

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients visiting Frederiksberg hospital for any reason

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Allan Storr-Paulsen, MD	Contact	+4538163646		allanstorr@dadlnet.dk

Overall Officials

Name	Affiliation	Role
Jens C Norregaard, MD, phd	Frederiksberg University Hospital, Eye Clinque	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Frederiksberg University Eye Clinque	Recruiting	Frederiksberg	Frederiksberg	2000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003317	Corneal Dystrophies, Hereditary
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases
D015785	Eye Diseases, Hereditary
D030342	Genetic Diseases, Inborn

Browse Leaves

Not provided

Browse Branches

Not provided