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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)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04251143
Enrollment
700
Registered
2020-01-31
Start date
2018-03-12
Completion date
2030-12-31
Last updated
2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Astigmatism, Corneal Disease, Corneal Ectasia, Keratoconus, Keratopathy

Keywords

Cornea, Ectasia, Keratoconus, Cross-Linking, Keratoplasty

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.

Interventions

UV-A Irradiation and riboflavin

DIAGNOSTIC_TESTcorneal topography and tomography

Detailed Information about corneal tomography is used for diagnosis

Sponsors

Technische Universität Dresden
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* corneal disease * corneal ectasia

Exclusion criteria

* pregnancy * age under 18 years

Design outcomes

Primary

MeasureTime frameDescription
Follow-up intervals15 yearsTo find the best follow-up intervals for keratoconus patients with or without progression of the disease
postoperative follow-up intervals15 yearsTo find the best follow-up intervals for keratoconus patients after surgical Intervention.

Secondary

MeasureTime frameDescription
Assessment of treatment quality15 yearsWhat is the best treatment option for the individual patient?

Countries

Germany

Contacts

Primary ContactRobert Herber, MSc
robert.herber@uniklinikum-dresden.de004935145815091
Backup ContactJanine Lenk, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026