High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study

February 19, 2020 updated by: Gerhard Garhofer, Medical University of Vienna
Corneal lesions such as corneal abrasions and corneal infiltrates are common in clinical practice. The current study seeks to investigate whether high-resolution OCT is suitable for imaging of these corneal lesions. The present study has the character of a pilot study and the results are intended to be used to develop a standardized protocol for imaging and analysis of these corneal lesions. Based on this protocol, further studies investigating the pathophysiology of corneal lesions or evaluating therapeutic success can be planned.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

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
        • Department of Clinical Pharmacology, Medical University of Vienna

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged over 18 years
  • Newly diagnosed corneal abrasion or corneal infiltrate

Exclusion Criteria:

  • Recurrent corneal erosion
  • Participation in a clinical trial in the previous 3 weeks
  • Presence of any abnormalities preventing reliable measurements as judged by the investigator
  • Any contraindication for topical application of Novain 0.4% eye drops for topical anesthesia or of Minims-Fluorescein Sodium eye drops for fluorescein staining
  • Pregnancy, planned pregnancy or lactating

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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 10 patients with corneal abrasions
Device: Optical Coherence Tomography (OCT)
High-resolution OCT imaging of the cornea
Other: Slit lamp biomicroscopy
Slit lamp biomicroscopy with fluorescein staining and slit lamp photograph
EXPERIMENTAL: 10 patients with corneal infiltrates
Device: Optical Coherence Tomography (OCT)
High-resolution OCT imaging of the cornea
Other: Slit lamp biomicroscopy
Slit lamp biomicroscopy with fluorescein staining and slit lamp photograph

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging of corneal abrasions and infiltrates
Time Frame: 1 day
The aim of this pilot study is to investigate whether imaging of these corneal alterations is possible.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Size and depth of corneal lesions as assessed with high-resolution OCT
Time Frame: 1 day
The volume and size of corneal lesions or infiltrates will be assessed using a specific software.
1 day
Slit lamp biomicroscopy with fluorescein staining
Time Frame: 1 day
The volume and size of corneal lesions or infiltrates will be assessed.
1 day

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)

July 23, 2013

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (ESTIMATE)

December 20, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-041112

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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