Agreement and Accuracy of Different Devices Corneal Measurements

March 2, 2021 updated by: Gerald Schmidinger

Agreement and Accuracy of Different Devices for the Measurement of Corneal Thickness and Corneal Curvature in Patients With Keratoconus

To compare repeatability, reproducibility and agreement of both, AS- OCT and Scheimpflug imaging, for the measurement of corneal curvature and corneal thickness in patients with keratoconus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

50 patients with keratoconus will be recruited in the outpatient department of the Department of Ophthalmology.

Description

Inclusion Criteria:

  • Men and women aged between 18 and 99 years
  • Presence of keratoconus
  • Signed informed consent

Exclusion Criteria:

  • Contact lens history within 5 days
  • Pathologic changes of the lid or conjunctiva on slit-lamp examination
  • History of corneal ocular surgery/Previous corneal cross-linking

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with keratoconus
Device: Pentacam® (Oculus, Inc., Wetzlar, Germany)
Scheimpflug imaging
Device: Casia II (Tomey Germany, Nürnberg)
Anterior segment optical coherence tomography
Device: Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)
Anterior segment optical coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximum K-value
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Simulated minimum and maximum K-value
Time Frame: 1 day
1 day
Mean K-values
Time Frame: 1 day
1 day
Central Corneal thickness
Time Frame: 1 day
1 day
Thinnest corneal point
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerald Schmidinger

Investigators

  • Principal Investigator: Gerald Schmidinger, Prof.Dr., Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2019

Primary Completion (Actual)

February 6, 2020

Study Completion (Actual)

February 6, 2020

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOPOC

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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