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

August 31, 2021 updated by: Gerhard Garhofer, Medical University of Vienna
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy volunteers
10 healthy volunteers
Device: Optical Coherence Tomography
Imaging of the cornea using ultrahigh resolution Spectral Domain OCT
Other: Corneal Neovascularisation
5 patients with corneal neovascularisation
Device: Optical Coherence Tomography
Imaging of the cornea using ultrahigh resolution Spectral Domain OCT
Other: Keratoconus
5 patients with keratoconus
Device: Optical Coherence Tomography
Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal Imaging
Time Frame: 1 day
Development of a measurement protocol for 3 dimensional imaging of the human cornea
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging of corneal pathologies
Time Frame: 1 day
Application of the protocol in patients with corneal pathologies
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Katarzyna Napora, MD, PhD, Department of Clinical Pharmacology, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2014

Primary Completion (Actual)

October 24, 2016

Study Completion (Actual)

October 24, 2016

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

April 30, 2013

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-040413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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