Dresden Corneal Disease and Treatment Study

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Brief Title

Dresden Corneal Disease and Treatment Study

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)

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.
    

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.
    


Study Type

Observational


Primary Outcome

Follow-up intervals

Secondary Outcome

 Assessment of treatment quality

Condition

Corneal Ectasia

Intervention

corneal cross-linking

Study Arms / Comparison Groups

 Ectasia
Description:  Keratoconus, Keratoconus suspects

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

700

Start Date

March 12, 2018

Completion Date

December 31, 2030

Primary Completion Date

December 31, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  corneal disease

          -  corneal ectasia

        Exclusion Criteria:

          -  pregnancy

          -  age under 18 years
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Frederik Raiskup, MD, PhD, 004935145815091, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04251143

Organization ID

EK 104032018


Responsible Party

Sponsor

Study Sponsor

Technische Universität Dresden


Study Sponsor

Frederik Raiskup, MD, PhD, Study Director, Department of Ophthalmology; Medical Faculty Carl Gustav Carus, Techinal University Dresden


Verification Date

September 2021