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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05604443
Other study ID # KUK-Ophthalmology-007
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 28, 2022
Est. completion date May 1, 2023

Study information

Verified date October 2023
Source Johannes Kepler University of Linz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 173
Est. completion date May 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers
Gender All
Age group 14 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
retrospective analyze
retrospective analyze of MS39 and Pentacam images

Locations

Country Name City State
Austria Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria Linz Oberösterreich

Sponsors (1)

Lead Sponsor Collaborator
Johannes Kepler University of Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary topography of the cornea measurement of the topography of the cornea with MS39 and Pentacam 12 months
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