Correlation Between In-vivo Anatomy of Corneal Dystrophies as Assessed by High- Resolution Optical Coherence Tomography (OCT) Measurement and Histological Examination - A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 2
- Locations
- 4
- Primary Endpoint
- Correlation in measurement of corneal layers in preoperative high-resolution OCT and histological diagnosis of corneal dystrophies of the removed cornea
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Gerhard Garhofer
Assoc. Prof. Priv.-Doz. Dr.
Medical University of Vienna