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Trial record 10 of 161 for:    Recruiting, Not yet recruiting, Available Studies | "Corneal Diseases"

Investigation of Different Scanning Protocols for 3 Dimensional High-resolution Imaging of the Human Cornea With Optical Coherence Tomography (OCT) - A Pilot Study

This study is currently recruiting participants.
Verified November 2016 by Gerhard Garhofer, Medical University of Vienna
Sponsor:
ClinicalTrials.gov Identifier:
NCT01843101
First Posted: April 30, 2013
Last Update Posted: December 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
  Purpose
The aim of the present study is to develop a protocol for optimal corneal 3-dimensional imaging based on measurements in healthy volunteers. For this purpose, a customized ultra-high resolution Spectral Domain OCT will be used. To validate whether the protocol can also be applied in patients with corneal pathologies, for whom it is intended to be used, measurements in these patients will be performed. We propose to obtain images from patients with keratoconus, since this is one of the most frequent causes for corneal transplantations in Europe and from patients with corneal neovascularization which is a major cause of vision loss in several ophthalmic diseases. Based on the obtained measurement protocol, further studies investigating the pathophysiology or treatment success of several corneal pathologies can be planned.

Condition Intervention Phase
Corneal Neovascularisation Keratoconus Device: Optical Coherence Tomography Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigation of Different Scanning Protocols for 3 Dimensional High-resolution Imaging of the Human Cornea With Optical Coherence Tomography (OCT) - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Gerhard Garhofer, Medical University of Vienna:

Primary Outcome Measures:
  • Corneal Imaging [ Time Frame: 1 day ]
    Development of a measurement protocol for 3 dimensional imaging of the human cornea


Secondary Outcome Measures:
  • Imaging of corneal pathologies [ Time Frame: 1 day ]
    Application of the protocol in patients with corneal pathologies


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Healthy volunteers
10 healthy volunteers
Device: Optical Coherence Tomography
Imaging of the cornea using ultrahigh resolution Spectral Domain OCT
Corneal Neovascularisation
5 patients with corneal neovascularisation
Device: Optical Coherence Tomography
Imaging of the cornea using ultrahigh resolution Spectral Domain OCT
Keratoconus
5 patients with keratoconus
Device: Optical Coherence Tomography
Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy volunteers:

  • Men and women aged over 18 years
  • Normal findings in the slit lamp examination, no corneal pathologies

Patients with keratoconus:

  • Men and women aged over 18 years
  • Presence of keratoconus
  • No ophthalmic surgery in the 3 months preceding the study

Patients with corneal neovascularization:

  • Men and women aged over 18 years
  • Presence of corneal neovascularization
  • No ophthalmic surgery in the 3 months preceding the study

Exclusion Criteria:

  • Participation in a clinical trial in the previous 3 weeks
  • Presence of any abnormalities preventing reliable measurements as judged by the investigator
  • Pregnancy, planned pregnancy or lactating
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843101


Contacts
Contact: Gerhard Garhoefer, MD +43 1 40400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhoefer, MD    +43 1 40400 ext 2981    gerhard.garhoefer@meduniwien.ac.at   
Principal Investigator: Katarzyna Napora, MD, PhD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Katarzyna Napora, MD, PhD Department of Clinical Pharmacology, Medical University of Vienna
  More Information

Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01843101     History of Changes
Other Study ID Numbers: OPHT-040413
First Submitted: April 26, 2013
First Posted: April 30, 2013
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by Gerhard Garhofer, Medical University of Vienna:
Optical Coherence Tomography
Cornea
Imaging

Additional relevant MeSH terms:
Neovascularization, Pathologic
Keratoconus
Corneal Neovascularization
Metaplasia
Pathologic Processes
Corneal Diseases
Eye Diseases