Working... Menu

Correlation Between In-vivo Anatomy of Corneal Dystrophies as Assessed by High- Resolution Optical Coherence Tomography (OCT) Measurement and Histological Examination

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. Identifier: NCT03461991
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : October 25, 2018
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Brief Summary:

Corneal dystrophies are usually classified histopathologically according to the layer of the cornea that is affected. The International Committee for the Classification of Corneal Dystrophies (IC3D) takes this anatomical classification as referral with summarizing clinical, genetic, and pathological data.

Most of this classification relies on slit lamp findings or histologic specimen, since in-vivo imaging of corneal microstructures has only become available in the recent years. With confocal microscopy it is possible to image corneal microstructures at a high resolution, but this technique is limited by its reduced repeatability and the fact that only a small area can be imaged. By the use of optical coherence tomography (OCT) systems it is possible to overcome these limitations. Commercially available systems, however, only have an axial resolution of about 18 µm which is not sufficient for imaging of all corneal layers.

Recently, a high-resolution optical coherence tomography (OCT) system was developed at the Center for Medical Physics and Biomedical Engineering that enables a resolution of about 1 µm. With this resolution, all corneal structures and several pathologies can be visualized.

In the present study the investigators want to use this OCT system to image corneal dystrophies in patients scheduled for corneal transplantation.

Condition or disease Intervention/treatment Phase
Corneal Dystrophy Device: Ultrahigh resolution Spectral Domain OCT Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Correlation Between In-vivo Anatomy of Corneal Dystrophies as Assessed by High- Resolution Optical Coherence Tomography (OCT) Measurement and Histological Examination - A Pilot Study
Actual Study Start Date : August 21, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

Arm Intervention/treatment
Patients scheduled for corneal transplantation Device: Ultrahigh resolution Spectral Domain OCT
A spectrometer based ultrahigh resolution Spectral Domain OCT (SDOCT) system operating at 800 nm for the anterior chamber will be employed in the present study. The spectrum of the Ti:Sapphire laser light source is centered at 800 nm. With a full width at half maximum bandwidth of 170 nm, the axial resolution is 1.3 μm in the cornea. The transverse resolution of the employed OCT system is 21 μm at the front surface of the cornea. For measurement, patients will place their head in a modified slit lamp head rest. During the measurement period, patients will be asked to look straight forward onto an internal fixation target and to avoid blinking. Different scattering patterns, e.g. raster, circular and spiral scans will be employed.

Primary Outcome Measures :
  1. Correlation in measurement of corneal layers in preoperative high-resolution OCT and histological diagnosis of corneal dystrophies of the removed cornea [ Time Frame: preoperative ]
    Preoperative high-resolution OCT measurement of the corneal layers in the study eye will be performed to assess corneal dystrophies. The corneal tissue removed during surgery will then be sent to the Institute for Clinical Pathology for histological preparation and diagnosis of corneal dystrophies. The correlation between the preoperative measurement and histological diagnosis will be shown to assess the accuracy of measuring corneal layers in high-resolution OCT imaging.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women aged over 18 years
  • Presence of corneal dystrophy
  • Scheduled for corneal transplantation (PK, ALK, DALK, DSAEK or DMEK)
  • No previous corneal surgery in the study eye

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

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 identifier (NCT number): NCT03461991

Layout table for location contacts
Contact: Gerhard Garhofer, MD 00431/40400 29880
Contact: Kristina Stjepanek, MD 0043140400 29880

Layout table for location information
Vienna Institute for Research in Ocular Surgery (VIROS) Recruiting
Vienna, Austria, 1140
Contact: Oliver Findl, MD, MBA    +43 (0)1 91021- 57564   
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, A-1090
Contact: Assoc.Prof.PD Garhoefer    +43 1 40400 2981   
Contact: PD MD Schmidl    +4314040029880   
Sponsors and Collaborators
Medical University of Vienna

Layout table for additonal information
Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv.-Doz. Dr., Medical University of Vienna Identifier: NCT03461991     History of Changes
Other Study ID Numbers: OPHT-270617
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn