ClinicalTrials.gov
ClinicalTrials.gov Menu

German Corneal Cross Linking Register

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00560651
Recruitment Status : Recruiting
First Posted : November 20, 2007
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Suphi Taneri, St. Franziskus Hospital

Brief Summary:

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 or disease Intervention/treatment
Keratoconus Procedure: CCL (Corneal Cross Linking)

Study Type : Observational
Estimated Enrollment : 7500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: German Corneal Cross Linking Register
Study Start Date : November 2007
Estimated Primary Completion Date : November 2027
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine


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:
  • Collagen cross linking
  • Corneal collagen cross linking
  • CCL
  • 3C-L




Primary Outcome Measures :
  1. Keratometry [ Time Frame: yearly ]

Secondary Outcome Measures :
  1. Slit-lamp biomicroscopical findings [ Time Frame: yearly ]
  2. Best corrected Visual Acuity [ Time Frame: Yearly ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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