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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
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Brief Summary:
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.

Condition or disease Intervention/treatment
Corneal Ectasia Corneal Disease Corneal Astigmatism Keratoconus Keratopathy Procedure: corneal cross-linking Diagnostic Test: corneal topography and tomography

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.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Ectasia
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




Primary Outcome Measures :
  1. Follow-up intervals [ Time Frame: 15 years ]
    To find the best follow-up intervals for keratoconus patients with or without progression of the disease

  2. postoperative follow-up intervals [ Time Frame: 15 years ]
    To find the best follow-up intervals for keratoconus patients after surgical Intervention.


Secondary Outcome Measures :
  1. Assessment of treatment quality [ Time Frame: 15 years ]
    What is the best treatment option for the individual patient?



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with corneal diseases attending a University Hospital Corneal Diseases Service.
Criteria

Inclusion Criteria:

  • corneal disease
  • corneal ectasia

Exclusion Criteria:

  • pregnancy
  • age under 18 years

Information from the National Library of Medicine

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


Contacts
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Contact: Robert Herber, MSc 004935145815091 robert.herber@uniklinikum-dresden.de
Contact: Janine Lenk, MD

Locations
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Germany
Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden Recruiting
Dresden, Saxony, Germany, 01307
Contact: Robert Herber    004935145815091    robert.herber@uniklinikum-dresden.de   
Sub-Investigator: Janine Lenk, MD         
Sub-Investigator: Naim Terai, MD         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
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Study Director: Frederik Raiskup, MD, PhD Department of Ophthalmology; Medical Faculty Carl Gustav Carus, Techinal University Dresden
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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT04251143    
Other Study ID Numbers: EK 104032018
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Technische Universität Dresden:
Cornea
Ectasia
Keratoconus
Cross-Linking
Keratoplasty
Additional relevant MeSH terms:
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Keratoconus
Astigmatism
Corneal Diseases
Dilatation, Pathologic
Eye Diseases
Refractive Errors
Pathological Conditions, Anatomical