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

Primary Purpose

Corneal Dystrophy

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Ultrahigh resolution Spectral Domain OCT
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Corneal Dystrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vienna Institute for Research in Ocular Surgery (VIROS)Recruiting
  • Department of Clinical Pharmacology, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients scheduled for corneal transplantation

Arm Description

Outcomes

Primary Outcome Measures

Correlation in measurement of corneal layers in preoperative high-resolution OCT and histological diagnosis of corneal dystrophies of the removed cornea
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.

Secondary Outcome Measures

Full Information

First Posted
January 2, 2018
Last Updated
April 6, 2022
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03461991
Brief Title
Correlation Between In-vivo Anatomy of Corneal Dystrophies as Assessed by High- Resolution Optical Coherence Tomography (OCT) Measurement and Histological Examination
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2018 (Actual)
Primary Completion Date
September 2, 2023 (Anticipated)
Study Completion Date
September 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Dystrophy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients scheduled for corneal transplantation
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Ultrahigh resolution Spectral Domain OCT
Intervention Description
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 Measure Information:
Title
Correlation in measurement of corneal layers in preoperative high-resolution OCT and histological diagnosis of corneal dystrophies of the removed cornea
Description
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.
Time Frame
preoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Garhofer, MD
Phone
00431/40400 29880
Email
gerhard.garhoefer@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Stjepanek, MD
Phone
0043140400 29880
Email
kristina.stjepanek@meduniwien.ac.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD, MBA
Phone
+43 (0)1 91021- 57564
Email
office@viros.at
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assoc.Prof.PD Garhoefer
Phone
+43 1 40400 2981
Email
gerhard.garhoefer@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
PD MD Schmidl
Phone
+4314040029880
Email
doreen.schmidl@meduniwien.ac.at

12. IPD Sharing Statement

Learn more about this trial

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

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