Comparation of Different Devices to Measure Corneal Thick... | NCT01251705

Studies
Comparation of Different Devices to Measure Corneal Thickness

NCT01251705

Sponsor

Technische Universität Dresden

Status

Unknown status

Last Update Posted

Dec 2, 2010Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

Corneal Thickness

Interventions

Not provided

Countries

Germany

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

Dec 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

Nov 2010

Primary Completion Date

Dec 2010Estimated

Completion Date

Feb 2011Estimated

First Submitted Date

Dec 1, 2010

First Submission Date that Met QC Criteria

Dec 1, 2010

First Posted Date

Dec 2, 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

Dec 1, 2010

Last Update Posted Date

Dec 2, 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

Comparison of different methods for measuring peoples corneal thickness

Detailed Description

Volunteers with healthy corneas will be measured by different instruments to detect their corneal thickness. First interindividual difference between the instruments will be reviewed. People will be measured again two times on two different days to examine an interindividual difference in all instruments.

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

70Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy cornea

Exclusion Criteria:

myopia or astigmatism over 1,5 dpt
corneal surgery
acute ocular inflammation
lost of vision

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

volunteers without corneal disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haustein, Doctor med.	Contact	0049351458	3381	Michael.Haustein@uniklinikum-dresden.de
Wozniak	Contact	0049351458	3381	Kathleen.Wozniak@uniklinikum-dresden.de

Overall Officials

Name	Affiliation	Role
Haustein, Doctor med.	Departement of Ophthalmology University of Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement of Ophthalmology	Recruiting	Dresden	Saxony	01307	Germany