Dresden Corneal Disease and Treatment Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Corneal Ectasia, Corneal Disease, Corneal Astigmatism, Keratoconus, Keratopathy

Intervention / Treatment
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* Procedure: corneal cross-linking
* Diagnostic Test: corneal topography and tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: corneal disease corneal ectasia Exclusion Criteria: pregnancy age under 18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ectasia<br>Keratoconus, Keratoconus suspects | Procedure: corneal cross-linking<br>* UV-A Irradiation and riboflavin<br>Diagnostic Test: corneal topography and tomography<br>* Detailed Information about corneal tomography is used for diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up intervals | To find the best follow-up intervals for keratoconus patients with or without progression of the disease | 15 years | 
| postoperative follow-up intervals | To find the best follow-up intervals for keratoconus patients after surgical Intervention. | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of treatment quality | What is the best treatment option for the individual patient? | 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cornea, Ectasia, Keratoconus, Cross-Linking, Keratoplasty