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Dresden Corneal Disease and Treatment Study

T

Technische Universität Dresden

Status

Enrolling

Conditions

Keratoconus
Corneal Disease
Keratopathy
Corneal Astigmatism
Corneal Ectasia

Treatments

Diagnostic Test: corneal topography and tomography
Procedure: corneal cross-linking

Study type

Observational

Funder types

Other

Identifiers

NCT04251143
EK 104032018

Details and patient eligibility

About

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.

Full 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.

Enrollment

700 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • corneal disease
  • corneal ectasia

Exclusion criteria

  • pregnancy
  • age under 18 years

Trial design

700 participants in 1 patient group

Ectasia
Description:
Keratoconus, Keratoconus suspects
Treatment:
Diagnostic Test: corneal topography and tomography
Procedure: corneal cross-linking

Trial contacts and locations

1

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Central trial contact

Janine Lenk, MD; Robert Herber, MSc

Data sourced from clinicaltrials.gov

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