Dresden Corneal Disease and Treatment Study

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Corneal Astigmatism; Keratoconus; Corneal Ectasia; Corneal Disease; Keratopathy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with corneal diseases attending a University Hospital Corneal Diseases Service.

Description

Inclusion Criteria:

• corneal disease
• corneal ectasia

Exclusion Criteria:

• pregnancy
• age under 18 years

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow-up intervals	To find the best follow-up intervals for keratoconus patients with or without progression of the disease	15 years
postoperative follow-up intervals	To find the best follow-up intervals for keratoconus patients after surgical Intervention.	15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of treatment quality	What is the best treatment option for the individual patient?	15 years

Collaborators and Investigators

• Sponsor: Technische Universität Dresden

Publications and helpful links

General Publications

• Herber R, Lenk J, Pillunat LE, Raiskup F. Comparison of corneal tomography using a novel swept-source optical coherence tomographer and rotating Scheimpflug system in normal and keratoconus eyes: repeatability and agreement analysis. Eye Vis (Lond). 2022 May 23;9(1):19. doi: 10.1186/s40662-022-00290-6.
• Herber R, Pillunat LE, Raiskup F. Development of a classification system based on corneal biomechanical properties using artificial intelligence predicting keratoconus severity. Eye Vis (Lond). 2021 Jun 1;8(1):21. doi: 10.1186/s40662-021-00244-4.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Cornea; Keratoconus; Ectasia; Cross-Linking; Keratoplasty
• Additional Relevant MeSH Terms: Eye Diseases; Pathological Conditions, Anatomical; Refractive Errors; Astigmatism; Keratoconus; Dilatation, Pathologic; Corneal Diseases
• Other Study ID Numbers: EK 104032018

Drug and device information, study documents

• 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