Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

German Corneal Cross Linking Register

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by St. Franziskus Hospital
Sponsor:
Information provided by (Responsible Party):
Suphi Taneri, St. Franziskus Hospital
ClinicalTrials.gov Identifier:
NCT00560651
First received: November 19, 2007
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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

Condition Intervention
Keratoconus
Procedure: CCL (Corneal Cross Linking)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: German Corneal Cross Linking Register

Resource links provided by NLM:


Further study details as provided by St. Franziskus Hospital:

Primary Outcome Measures:
  • Keratometry [ Time Frame: yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Slit-lamp biomicroscopical findings [ Time Frame: yearly ] [ Designated as safety issue: No ]
  • Best corrected Visual Acuity [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Estimated Enrollment: 7500
Study Start Date: November 2007
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • Collagen cross linking
  • Corneal collagen cross linking
  • CCL
  • 3C-L

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients treated with Corneal Cross Linking in Germany

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-ectatic conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560651

Contacts
Contact: Suphi Taneri, MD 49-251-987-7890 taneri@refraktives-zentrum.de
Contact: Saskia Oehler 49-251-987-7890 oehler@refraktives-zentrum.de

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

Additional Information:
Publications:
Responsible Party: Suphi Taneri, Director, St. Franziskus Hospital
ClinicalTrials.gov Identifier: NCT00560651     History of Changes
Other Study ID Numbers: CCL
Study First Received: November 19, 2007
Last Updated: November 18, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by St. Franziskus Hospital:
keratoconus
cornea
cross linking
UV-light
riboflavin

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on November 25, 2014