Keratoconus Detection Using MS39 and Pentacam (KKMS39Penta)

Keratoconus Detection Using MS39 and Pentacam - a Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Keratoconus
• Intervention / Treatment: Other: retrospective analyze

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.

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

• Study Contact: Name: Nino Hirnschall, MD; Phone Number: 1048 +435768083; Email: nino.hirnschall@kepleruniklinikum.at
• Study Contact Backup: Name: Matthias Bolz, MD; Phone Number: 1050 +4357680883; Email: matthias.bolz@kepleruniklinikum.at

Study Locations

• Austria
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4020
      • Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients between 14 and 100 years who consult Keratokonus specialst.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johannes Kepler University of Linz
• Investigators: Principal Investigator: Matthias Bolz, MD, JKU Linz

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Keratoconus; Pentacam; MS39
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: KUK-Ophthalmology-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No