Dresden Corneal Disease and Treatment Study

Sponsor
Technische Universität Dresden (Other)
Overall Status
Recruiting
CT.gov ID
NCT04251143
Collaborator
(none)
700
1
153.7
4.6

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Mar 12, 2018
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2030

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Follow-up intervals [15 years]

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

  2. postoperative follow-up intervals [15 years]

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

Secondary Outcome Measures

  1. Assessment of treatment quality [15 years]

    What is the best treatment option for the individual patient?

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • corneal disease

  • corneal ectasia

Exclusion Criteria:
  • pregnancy

  • age under 18 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden Dresden Saxony Germany 01307

Sponsors and Collaborators

  • Technische Universität Dresden

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT04251143
Other Study ID Numbers:
  • EK 104032018
First Posted:
Jan 31, 2020
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2021