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NCT Number: NCT04251143

Dresden Corneal Disease and Treatment Study

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden

Dresden, Saxony, 01307, Germany

Location status: Recruiting

Location contact

Janine Lenk, MD

SUB_INVESTIGATOR

Naim Terai, MD

SUB_INVESTIGATOR

Robert Herber

CONTACT

[email protected]

004935145815091

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • corneal disease
  • corneal ectasia

Exclusion criteria

  • pregnancy
  • age under 18 years

Treatment and study plan

Corneal Cross-linking

Procedure

UV-A Irradiation and riboflavin

corneal topography and tomography

Diagnostic Test

Detailed Information about corneal tomography is used for diagnosis

Primary outcomes

  1. Follow-up intervals

    Time frame: 15 years

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

  2. postoperative follow-up intervals

    Time frame: 15 years

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

Secondary outcomes

  1. Assessment of treatment quality

    Time frame: 15 years

    What is the best treatment option for the individual patient?

Study contacts

Contact information is provided by the study sponsor or research team.

Janine Lenk, MD

CONTACT

Robert Herber, MSc

CONTACT

[email protected]

004935145815091

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2025
Study completion
2030
First posted
Jan 31, 2020
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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