German Corneal Cross Linking Register

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Estimated Enrollment :	7500 participants
Time Perspective:	Prospective
Official Title:	German Corneal Cross Linking Register
Study Start Date :	November 2007
Estimated Primary Completion Date :	November 2017
Estimated Study Completion Date :	November 2017

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

German Ophthalmological Society, Cornea section 

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
First Posted:	November 20, 2007
Last Update Posted:	October 18, 2016
Last Verified:	October 2016

Keywords provided by Suphi Taneri, St. Franziskus Hospital:

keratoconus; cornea; cross linking; UV-light; riboflavin

Additional relevant MeSH terms:

Keratoconus; Corneal Diseases; Eye Diseases