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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT01753583
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.3
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Abrasions; Corneal Infiltrates	Device: Optical Coherence Tomography (OCT); Other: Slit lamp biomicroscopy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study
• Actual Study Start Date: Jul 23, 2013
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Slit lamp biomicroscopy with fluorescein staining [1 day]

   The volume and size of corneal lesions or infiltrates will be assessed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT01753583
• Other Study ID Numbers: OPHT-041112
• First Posted: Dec 20, 2012
• Last Update Posted: Feb 20, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna: optical coherence tomography; corneal abrasion; corneal infiltrate
• Additional relevant MeSH terms: Corneal Injuries

Study Results

No Results Posted as of Feb 20, 2020