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Clinical Trials/NCT04251143
NCT04251143
Recruiting
Not Applicable

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)

Technische Universität Dresden1 site in 1 country700 target enrollmentMarch 12, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Corneal Ectasia
Sponsor
Technische Universität Dresden
Enrollment
700
Locations
1
Primary Endpoint
postoperative follow-up intervals
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 12, 2018
End Date
December 31, 2030
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • corneal disease
  • corneal ectasia

Exclusion Criteria

  • pregnancy
  • age under 18 years

Outcomes

Primary Outcomes

postoperative follow-up intervals

Time Frame: 15 years

To find the best follow-up intervals for keratoconus patients after surgical Intervention.

Follow-up intervals

Time Frame: 15 years

To find the best follow-up intervals for keratoconus patients with or without progression of the disease

Secondary Outcomes

  • Assessment of treatment quality(15 years)

Study Sites (1)

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