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Completed

NCT Number: NCT01753583

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical coherence tomography (OCT)

Device

High-resolution OCT imaging of the cornea

Slit lamp biomicroscopy

Other

Slit lamp biomicroscopy with fluorescein staining and slit lamp photograph

Primary outcomes

  1. Imaging of corneal abrasions and infiltrates

    Time frame: 1 day

    The aim of this pilot study is to investigate whether imaging of these corneal alterations is possible.

Secondary outcomes

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

    Time frame: 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

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 20, 2012
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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