Distinguishing Healthy and Keratoconic Eyes Using Ultrahi... | NCT03184610

Studies
Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution OCT

NCT03184610

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Jun 12, 2017Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Keratoconus

Interventions

OCT-scanning

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

Jun 2017

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

Dec 2014Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Not provided

First Submitted Date

Jun 9, 2017

First Submission Date that Met QC Criteria

Jun 9, 2017

First Posted Date

Jun 12, 2017Actual

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

Jun 9, 2017

Last Update Posted Date

Jun 12, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gerald Schmidinger, Ass.Prof. PD Dr. Gerald Schmidinger, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

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

The OCT used in this trial offers the advantage of both a non-contact method and a very high axial resolution. Determined parameters with the highest potential of diagnostic discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this trial is to investigate differences of specific parameters of epithelium thickness maps at healthy eyes and eyes 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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OCT-scanning		Patients with Keratoconus are scanned with an OCT-Prototype	Device: OCT-scanning
OCT-scanning for volunteers		Volunteers with healthy eyes are scanned with an OCT-Prototype	Device: OCT-scanning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OCT-scanning	Device	All participants will be scanned with a OCT-device	OCT-scanning OCT-scanning for volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corneal Epithelium Thickness	Parameters collected from epithelium thickness data and maps	One visit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age>18
Existence of Keratoconus
written informed consent obtained

Exclusion Criteria:

Earlier surgery such as PK, CXL, relaxing incisions
Systemic diseases

Accepts Healthy Volunteers

Yes

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

Eyes with Keratoconus Healthy eyes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

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

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases