Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution OCT

June 9, 2017 updated by: Gerald Schmidinger, Medical University of Vienna

Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution Optical Coherence Tomography (UHR-OCT) Based Corneal Epithelium Thickness Mapping

The OCT used in this trial offers the advantage of both a non-contact method and a very high axial resolution. Determined parameters with the highest potential of diagnostic discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this trial is to investigate differences of specific parameters of epithelium thickness maps at healthy eyes and eyes with Keratoconus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eyes with Keratoconus Healthy eyes

Description

Inclusion Criteria:

  • Age>18
  • Existence of Keratoconus
  • written informed consent obtained

Exclusion Criteria:

  • Earlier surgery such as PK, CXL, relaxing incisions
  • Systemic diseases

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OCT-scanning
Patients with Keratoconus are scanned with an OCT-Prototype
Device: OCT-scanning
All participants will be scanned with a OCT-device
OCT-scanning for volunteers
Volunteers with healthy eyes are scanned with an OCT-Prototype
Device: OCT-scanning
All participants will be scanned with a OCT-device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal Epithelium Thickness
Time Frame: One visit
Parameters collected from epithelium thickness data and maps
One visit

Collaborators and Investigators

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

Sponsor

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)

December 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 9, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160/2014

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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