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 not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01843101
First received: April 26, 2013
Last updated: April 29, 2013
Last verified: April 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Medical University of Vienna:

Primary Outcome Measures:
  • Corneal Imaging [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Development of a measurement protocol for 3 dimensional imaging of the human cornea


Secondary Outcome Measures:
  • Imaging of corneal pathologies [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Application of the protocol in patients with corneal pathologies


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01843101

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

Locations
Austria
Department of Clinical Pharmacology Not yet 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

No publications provided

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
Study First Received: April 26, 2013
Last Updated: April 29, 2013
Health Authority: Austria: Austrian Federal Office for Safety in Health Care

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

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

ClinicalTrials.gov processed this record on July 20, 2014