Suspended

Comparison of Two Optical Coherence Tomography Devices in Corneal Epithelial Thickness Maps

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Corneal epithelial thickness measurements

Diagnostic Test
Who is being recruted

Corneal Diseases

+ Eye Diseases

+ Keratoconus

From 21 to 100 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: October 2020
See protocol details

Summary

Principal SponsorVienna Institute for Research in Ocular Surgery
Study ContactOliver Findl, Prof., MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 15, 2020

Actual date on which the first participant was enrolled.

In total 50 eyes of 50 patients will be included, divided into two groups: study group comprised of 20 eyes with diagnosed keratoconus and a control group formed out of 30 healthy eyes. Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation. After each measurement patients will be asked to blink in order to allow adequate tear-film recovery. Each patient will be measured three times with both devices. Only one visit will be necessary. The order in which the measurements will be performed (Anterion or MS-39) will be randomised using randomised.org. The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces. Main outcome variable: \- Mean differences in central corneal epithelial thickness between the devices investigated (+ limits of agreement (1.96xSD) between the investigated devices) Secondary outcome variables: * Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation of the two devices * Comparison in epithelial thickness between normal and keratoconus eyes * Sensitivity and specificity of swept-source OCT device in keratoconus diagnosis

Official TitleComparison of Two Optical Coherence Tomography Devices in Corneal Epithelial Thickness Maps
NCT04578184
Principal SponsorVienna Institute for Research in Ocular Surgery
Study ContactOliver Findl, Prof., MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Corneal DiseasesEye DiseasesKeratoconus

Criteria

Inclusion Criteria: * Patient with diagnosed keratoconus (diagnosed using tomography and topography map changes and slit-lamp changes) and patients with healthy cornea * Age 21 and older * Signed informed consent Exclusion Criteria: * Previous ocular surgery * Associated corneal pathologies (e.g. trauma, edema, scarring) * In women of childbearing age, a pregnancy test will be performed before inclusion into the study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation Each patient will be measured three times with both devices. The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces.

Group II

Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation Each patient will be measured three times with both devices. The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hanusch Hospital, Ophthalmology Department

Vienna, AustriaOpen Hanusch Hospital, Ophthalmology Department in Google Maps
SuspendedOne Study Center