German Corneal Cross Linking Register

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2016 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: October 16, 2016

Last verified: October 2016

History of Changes

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

Applying Riboflavin (Vitamin B2) eye drops every 2 minutes for 30 minutes to the cornea
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:

Genetic and Rare Diseases Information Center resources: Keratoconus

U.S. FDA Resources

Further study details as provided by St. Franziskus Hospital:

Primary Outcome Measures:

Keratometry [ Time Frame: yearly ]

Secondary Outcome Measures:

Slit-lamp biomicroscopical findings [ Time Frame: yearly ]
Best corrected Visual Acuity [ Time Frame: Yearly ]


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


Ages Eligible for Study:	Child, Adult, Senior
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

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:

German Ophthalmological Society, Cornea section This link exits the ClinicalTrials.gov site

Publications:

Koller T, Seiler T. [Therapeutic cross-linking of the cornea using riboflavin/UVA]. Klin Monbl Augenheilkd. 2007 Sep;224(9):700-6. Review. German.

Spoerl E, Mrochen M, Sliney D, Trokel S, Seiler T. Safety of UVA-riboflavin cross-linking of the cornea. Cornea. 2007 May;26(4):385-9. Review.

Seiler T, Hafezi F. Corneal cross-linking-induced stromal demarcation line. Cornea. 2006 Oct;25(9):1057-9.

Wollensak G, Aurich H, Pham DT, Wirbelauer C. Hydration behavior of porcine cornea crosslinked with riboflavin and ultraviolet A. J Cataract Refract Surg. 2007 Mar;33(3):516-21.


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:	October 16, 2016

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 May 25, 2017

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