Dresden Corneal Disease and Treatment Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: corneal cross-linking, corneal topography and tomography.
- Who it may be relevant to
- Registry conditions: Corneal Ectasia, Corneal Disease, Corneal Astigmatism, Keratoconus. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dresden Corneal Disease and Treatment Study - Analysis for Quality Inspection of Follow-up and Treatment Procedures of Corneal Diseases of the Department of Ophthalmology (University Hospital Carl Gustav Carus Dresden)
Overview
The purpose of this study is long-term follow up of patients with corneal diseases to analyze the quality of surgical interventions and diagnosis. Corneal ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of visual acuity while the cornea becomes steeper, thinner and irregular. For these patients, surgical intervention (e.g. corneal cross-linking) is performed, in case of disease progression. Overall, a long-term follow up is needed to evaluate an early disease progression as well as corneal stability after surgical intervention.
Detailed description
Corneal ectasia (e.g. keratoconus) is a corneal disease that is characterized by irregular steepening of corneal curvature, stromal thinning and reduced biomechanical properties. As a result of this, visual acuity is reduced and can improved by spectacles in early state or with rigid gas permeable contact lenses in mild as well as advanced stage of the disease. Furthermore, in moderate and advanced cases stromal scarring occurs that affected the vision negatively. Therefore, a corneal transplantation is needed. Since the introduction of corneal cross-linking, the amount of corneal transplantations has been reduced. It is necessary to perform closely examinations to detect the progression of the disease as well as post-operatively follow-ups to confirm treatment success.
Parameters being analyzed are:
Age, sex, refraction, family history, known duration of ectasia, previous ocular surgery, systemic diseases, systemic and topical medication;
biomicroscopy, anterior optical coherence tomography (OCT), Scheimpflug-based tomography (Pentacam), Biomechanical assessment (Ocular Response Analyzer and Corneal Visualization with the Scheimpflug Technology), optical biometry, confocal microscopy, endothelium cell count.
Interventions
- Procedure corneal cross-linking
UV-A Irradiation and riboflavin - Diagnostic test corneal topography and tomography
Detailed Information about corneal tomography is used for diagnosis
Primary outcome measures
- Follow-up intervals [Time frame: 15 years]
- postoperative follow-up intervals [Time frame: 15 years]
Secondary outcome measures (1)
- Assessment of treatment quality [Time frame: 15 years]
Eligibility criteria
Inclusion criteria
- corneal disease
- corneal ectasia
Exclusion criteria
- pregnancy
- age under 18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresd — Dresden
Publications
- Herber R, Lenk J, Pillunat LE, Raiskup F. Comparison of corneal tomography using a novel swept-source optical coherence tomographer and rotating Scheimpflug system in normal and keratoconus eyes: repeatability and agreement analysis. Eye Vis (Lond). 2022 May 23;9(1):19. doi: 10.1186/s40662-022-00290-6. PMID 35606839
- Herber R, Pillunat LE, Raiskup F. Development of a classification system based on corneal biomechanical properties using artificial intelligence predicting keratoconus severity. Eye Vis (Lond). 2021 Jun 1;8(1):21. doi: 10.1186/s40662-021-00244-4. PMID 34059127
Identifiers
NCT: NCT04251143 · EK 104032018