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

Not Applicable

Completed

• Conditions: Corneal Abrasions; Corneal Infiltrates
• Interventions: Device: Optical Coherence Tomography (OCT); Other: Slit lamp biomicroscopy

• Registration Number: NCT01753583
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Study Start: 2013-07-23
• Primary Completion: 2016-03-01
• Study Completion: 2016-03-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 patients with corneal infiltrates	Slit lamp biomicroscopy	-
10 patients with corneal abrasions	Slit lamp biomicroscopy	-
10 patients with corneal infiltrates	Optical Coherence Tomography (OCT)	-
10 patients with corneal abrasions	Optical Coherence Tomography (OCT)	-

Primary Outcome Measures

Name	Time	Method
Imaging of corneal abrasions and infiltrates	1 day	The aim of this pilot study is to investigate whether imaging of these corneal alterations is possible.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria