Keratoconus Detection Using MS39 and Pentacam | NCT05604443

Studies
Keratoconus Detection Using MS39 and Pentacam

NCT05604443

Sponsor

Johannes Kepler University of Linz

Status

Completed

Last Update Posted

Oct 13, 2023Actual

Enrollment

173Actual

Phase

Not provided

Conditions

Keratoconus

Interventions

retrospective analyze

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

Oct 2023

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 28, 2022Actual

Primary Completion Date

Apr 1, 2023Actual

Completion Date

May 1, 2023Actual

First Submitted Date

Oct 5, 2022

First Submission Date that Met QC Criteria

Nov 2, 2022

First Posted Date

Nov 3, 2022Actual

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

Oct 12, 2023

Last Update Posted Date

Oct 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This retrospective study aims to investigate whether the MS39 and Pentacam are delivering comparable results in the diagnosis of keratoconus.

In the future, these measurement devices could be interchangeable in usage.

Detailed Description

Keratoconus is a degenerative pathology of the cornea, which tends to progress. It comes along with central and paracentral thinning of the cornea as well as with an apical protrusion of the cornea. Keratoconus leads to vision loss. This pathology is diagnosed by using CE certified OCT technology in order to map the topography of the cornea. This process constitutes a really important step in the line of management of the keratoconus. MS39 and Pentacam are used for detection. Retrospectively, data will be investigated, in order to see if these measurement devices deliver comparable results. In the future, these measurement devices could be interchangeable in usage.

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

173Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
retrospective analyze	Other	retrospective analyze of MS39 and Pentacam images

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
topography of the cornea	measurement of the topography of the cornea with MS39 and Pentacam	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age older than 14 years
patients who show up at Keratokonus consultation hours

Exclusion Criteria:

age younger than 14 years
age older than 100 years

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

patients between 14 and 100 years who consult Keratokonus specialst.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias Bolz, MD	JKU Linz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria		Linz	Upper Austria	4020	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