Dresden Corneal Disease and Treatment Study
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|ClinicalTrials.gov Identifier: NCT04251143|
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment|
|Corneal Ectasia Corneal Disease Corneal Astigmatism Keratoconus Keratopathy||Procedure: corneal cross-linking Diagnostic Test: corneal topography and tomography|
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.
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|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)|
|Actual Study Start Date :||March 12, 2018|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2030|
Keratoconus, Keratoconus suspects
Procedure: corneal cross-linking
UV-A Irradiation and riboflavin
Diagnostic Test: corneal topography and tomography
Detailed Information about corneal tomography is used for diagnosis
- Follow-up intervals [ Time Frame: 15 years ]To find the best follow-up intervals for keratoconus patients with or without progression of the disease
- postoperative follow-up intervals [ Time Frame: 15 years ]To find the best follow-up intervals for keratoconus patients after surgical Intervention.
- Assessment of treatment quality [ Time Frame: 15 years ]What is the best treatment option for the individual patient?
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 ClinicalTrials.gov identifier (NCT number): NCT04251143
|Contact: Robert Herber, MScemail@example.com|
|Contact: Janine Lenk, MD|
|Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden||Recruiting|
|Dresden, Saxony, Germany, 01307|
|Contact: Robert Herber 004935145815091 firstname.lastname@example.org|
|Sub-Investigator: Janine Lenk, MD|
|Sub-Investigator: Naim Terai, MD|
|Study Director:||Frederik Raiskup, MD, PhD||Department of Ophthalmology; Medical Faculty Carl Gustav Carus, Techinal University Dresden|