Dresden Corneal Disease and Treatment Study

Keratoconus Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04251143
• Other study ID #: EK 104032018
• Status: Recruiting
• Start date: March 12, 2018
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2023
• Source: Technische Universität Dresden
• Contact: Robert Herber, MSc
• Phone: 004935145815091
• Email: robert.herber[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• corneal disease

• corneal ectasia

Exclusion Criteria:

• pregnancy

• age under 18 years

Related Conditions & MeSH terms

• Astigmatism
• Corneal Astigmatism
• Corneal Disease
• Corneal Diseases
• Corneal Ectasia
• Keratoconus
• Keratopathy

Intervention

Procedure:
• corneal cross-linking
UV-A Irradiation and riboflavin

Diagnostic Test:
• corneal topography and tomography
Detailed Information about corneal tomography is used for diagnosis

Locations

Country	Name	City	State
Germany	Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follow-up intervals	To find the best follow-up intervals for keratoconus patients with or without progression of the disease	15 years
Primary	postoperative follow-up intervals	To find the best follow-up intervals for keratoconus patients after surgical Intervention.	15 years
Secondary	Assessment of treatment quality	What is the best treatment option for the individual patient?	15 years