Back to resultsHigh-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study
Primary Purpose
Corneal Abrasions, Corneal Infiltrates
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Optical Coherence Tomography (OCT)
Slit lamp biomicroscopy
Sponsored by
About this trial
This is an interventional basic science trial for Corneal Abrasions focused on measuring optical coherence tomography, corneal abrasion, corneal infiltrate
Eligibility 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
Sites / Locations
- Department of Clinical Pharmacology, Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
10 patients with corneal abrasions
10 patients with corneal infiltrates
Arm Description
Outcomes
Primary Outcome Measures
Imaging of corneal abrasions and infiltrates
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
The volume and size of corneal lesions or infiltrates will be assessed using a specific software.
Slit lamp biomicroscopy with fluorescein staining
The volume and size of corneal lesions or infiltrates will be assessed.
Full Information
NCT ID
NCT01753583
First Posted
December 7, 2012
Last Updated
February 19, 2020
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01753583
Brief Title
High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study
Official Title
High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 23, 2013 (Actual)
Primary Completion Date
March 1, 2016 (Actual)
Study Completion Date
March 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Abrasions, Corneal Infiltrates
Keywords
optical coherence tomography, corneal abrasion, corneal infiltrate
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 patients with corneal abrasions
Arm Type
Experimental
Arm Title
10 patients with corneal infiltrates
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Optical Coherence Tomography (OCT)
Intervention Description
High-resolution OCT imaging of the cornea
Intervention Type
Other
Intervention Name(s)
Slit lamp biomicroscopy
Intervention Description
Slit lamp biomicroscopy with fluorescein staining and slit lamp photograph
Primary Outcome Measure Information:
Title
Imaging of corneal abrasions and infiltrates
Description
The aim of this pilot study is to investigate whether imaging of these corneal alterations is possible.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Size and depth of corneal lesions as assessed with high-resolution OCT
Description
The volume and size of corneal lesions or infiltrates will be assessed using a specific software.
Time Frame
1 day
Title
Slit lamp biomicroscopy with fluorescein staining
Description
The volume and size of corneal lesions or infiltrates will be assessed.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study
We'll reach out to this number within 24 hrs