search
Back to results

High-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
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 7, 2012
Last Updated
February 19, 2020
Sponsor
Medical University of Vienna
search

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