Agreement and Accuracy of Different Devices Corneal Measu... | NCT04383366

Studies
Agreement and Accuracy of Different Devices Corneal Measurements

NCT04383366

Sponsor

Gerald Schmidinger

Status

Completed

Last Update Posted

Mar 3, 2021Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Keratoconus

Interventions

Pentacam® (Oculus, Inc., Wetzlar, Germany)
Casia II (Tomey Germany, Nürnberg)
Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)

Countries

Austria

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 21, 2019Actual

Primary Completion Date

Feb 6, 2020Actual

Completion Date

Feb 6, 2020Actual

First Submitted Date

May 7, 2020

First Submission Date that Met QC Criteria

May 11, 2020

First Posted Date

May 12, 2020Actual

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 2, 2021

Last Update Posted Date

Mar 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

To compare repeatability, reproducibility and agreement of both, AS- OCT and Scheimpflug imaging, for the measurement of corneal curvature and corneal thickness in patients with keratoconus.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with keratoconus			Device: Pentacam® (Oculus, Inc., Wetzlar, Germany) Device: Casia II (Tomey Germany, Nürnberg) Device: Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pentacam® (Oculus, Inc., Wetzlar, Germany)	Device	Scheimpflug imaging	Patients with keratoconus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
maximum K-value		1 day

Secondary Outcomes

Measure	Description	Time Frame
Simulated minimum and maximum K-value		1 day
Mean K-values		1 day
Central Corneal thickness

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women aged between 18 and 99 years
Presence of keratoconus
Signed informed consent

Exclusion Criteria:

Contact lens history within 5 days
Pathologic changes of the lid or conjunctiva on slit-lamp examination
History of corneal ocular surgery/Previous corneal cross-linking

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

50 patients with keratoconus will be recruited in the outpatient department of the Department of Ophthalmology.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerald Schmidinger, Prof.Dr.	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna, Department of Ophthalmology		Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007640	Keratoconus

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided