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

This study is currently recruiting participants.
Verified April 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01753583
First received: December 7, 2012
Last updated: April 4, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Corneal Abrasions
Corneal Infiltrates
 Device: Optical Coherence Tomography (OCT)
Other: Slit lamp biomicroscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Imaging of corneal abrasions and infiltrates [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The aim of this pilot study is to investigate whether imaging of these corneal alterations is possible.


Secondary Outcome Measures:
  • Size and depth of corneal lesions as assessed with high-resolution OCT [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The volume and size of corneal lesions or infiltrates will be assessed using a specific software.

  • Slit lamp biomicroscopy with fluorescein staining [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The volume and size of corneal lesions or infiltrates will be assessed.


Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753583

Contacts
Contact: Gerhard Garhoefer, MD +43140400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhoefer, MD     +43140400 ext 2981     gerhard.garhoefer@meduniwien.ac.at    
Principal Investigator: Katarzyna Napora, MD            
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01753583     History of Changes
Other Study ID Numbers: OPHT-041112
Study First Received: December 7, 2012
Last Updated: April 4, 2013
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University of Vienna:
optical coherence tomography
corneal abrasion
corneal infiltrate

ClinicalTrials.gov processed this record on May 23, 2013