German Corneal Cross Linking Register

April 16, 2024 updated by: Suphi Taneri

Corneal Cross Linking is new treatment modality for patients with keratoconus. A keratoconus is characterized by progressive bulging and thinning of the eye's cornea. Keratoconus is a potentially severely sight impairing condition that may necessitate corneal transplantation in the progressive state.

Corneal Cross Linking is designed to

  • increase the cornea's mechanical stability
  • to stop progression of bulging and thinning of the cornea
  • to prevent the need for corneal transplantation

Corneal Cross Linking is performed by

  1. Applying Riboflavin (Vitamin B2) eye drops every 2 minutes for 30 minutes to the cornea
  2. Illuminating the cornea with UV-light

This register of Corneal Cross Linking procedures performed in Germany serves to

  • gather long-term results
  • detect rare complications and side-effects
  • evaluate the efficacy in a large number of patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

7500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Homburg, Germany, 66421
        • Recruiting
        • University of Saar
        • Principal Investigator:
          • Berthold Seitz, MD
        • Sub-Investigator:
          • Atilla Osvald, MD
      • Münster, Germany, 48145
        • Recruiting
        • Augenklinik am St. Franziskus Hospital
        • Principal Investigator:
          • Suphi Taneri, MD
        • Sub-Investigator:
          • Arnd Heiligenhaus, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients treated with Corneal Cross Linking in Germany

Description

Inclusion Criteria:

  • Patients diagnosed with keratokonus and treated with corneal cross Linking in Germany

Exclusion Criteria:

  • Non-ectatic conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Cross linked eyes
Procedure: CCL (Corneal Cross Linking)
Apply Riboflavin 0.1% in Dextran 500 20% in NaCl solution Illuminate with UV-light of 365 nm wave-length and 3.0 mW/cm² intensity at 5 cm distance
Other Names:
  • CCL
  • Collagen cross linking
  • Corneal collagen cross linking
  • 3C-L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Keratometry
Time Frame: yearly
yearly

Secondary Outcome Measures

Outcome Measure
Time Frame
Slit-lamp biomicroscopical findings
Time Frame: yearly
yearly
Best corrected Visual Acuity
Time Frame: Yearly
Yearly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suphi Taneri

Investigators

  • Study Chair: Suphi Taneri, MD, Augenklinik am St. Franziskus Hospital
  • Study Director: Berthold Seitz, MD, University of Homburg, Saar, Germany
  • Study Director: Philip Maier, MD, Univer. Freiburg, Germany
  • Study Director: Claus Cursiefen, MD, Univer. Erlangen, Germany
  • Principal Investigator: Thomas Reinhard, MD, Univers. Freiburg
  • Principal Investigator: Arnd Heiligenhaus, MD, Augenklinik am St.Franzsikus Hospital, Münster
  • Principal Investigator: Walter Sekundo, MD, Univers. Mainz
  • Principal Investigator: Theo Seiler, MD, IROC, Zürich
  • Principal Investigator: Atilla Osvald, MD, Univers Homurg, Saar
  • Principal Investigator: Jan M Vetter, MD, Univers. Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

November 19, 2007

First Submitted That Met QC Criteria

November 19, 2007

First Posted (Estimated)

November 20, 2007

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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