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

Corneal Infiltrates Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753583
• Other study ID #: OPHT-041112
• Status: Completed
• Phase: N/A
• Start date: July 23, 2013
• Est. completion date: March 1, 2016

Study information

• Verified date: February 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: March 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Abrasions
• Corneal Infiltrates

Intervention

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

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging of corneal abrasions and infiltrates	The aim of this pilot study is to investigate whether imaging of these corneal alterations is possible.	1 day
Secondary	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.	1 day
Secondary	Slit lamp biomicroscopy with fluorescein staining	The volume and size of corneal lesions or infiltrates will be assessed.	1 day