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

NCT01753583 | Completed

• 1 other identifier: OPHT-041112
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Abrasions; Corneal Infiltrates

Keywords

optical coherence tomography; corneal abrasion; corneal infiltrate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Size and depth of corneal lesions as assessed with high-resolution OCT

  1 day

• Slit lamp biomicroscopy with fluorescein staining

  1 day

Study Arms (2)

10 patients with corneal abrasions

EXPERIMENTAL

Device: Optical Coherence Tomography (OCT); Other: Slit lamp biomicroscopy

10 patients with corneal infiltrates

EXPERIMENTAL

Device: Optical Coherence Tomography (OCT); Other: Slit lamp biomicroscopy

Interventions

Optical Coherence Tomography (OCT) DEVICE

High-resolution OCT imaging of the cornea

10 patients with corneal abrasions; 10 patients with corneal infiltrates

Slit lamp biomicroscopy OTHER

Slit lamp biomicroscopy with fluorescein staining and slit lamp photograph

10 patients with corneal abrasions; 10 patients with corneal infiltrates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Corneal Injuries

Interventions

Tomography, Optical Coherence; Slit Lamp

Condition Hierarchy (Ancestors)

Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Ophthalmoscopes; Diagnostic Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 20, 2012
• Study Start: July 23, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

AU (1)