Clinical trial NCT00560651: German Corneal Cross Linking Register
Official title: German Corneal Cross Linking Register
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Keratoconus
Keywords: keratoconus
cornea
cross linking
UV-light
riboflavin
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
First posted: 2007-11-20
Enrollment: 7500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with Corneal Cross Linking in Germany

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Non-ectatic conditions

Primary outcomes:
measure: Keratometry
timeFrame: yearly
Secondary outcomes:
measure: Slit-lamp biomicroscopical findings
timeFrame: yearly
measure: Best corrected Visual Acuity
timeFrame: Yearly
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University of Saar
city: Münster
country: Germany
facility: Augenklinik am St. Franziskus Hospital
Study officials:
affiliation: Augenklinik am St. Franziskus Hospital
name: Suphi Taneri, MD
role: STUDY_CHAIR
affiliation: University of Homburg, Saar, Germany
name: Berthold Seitz, MD
role: STUDY_DIRECTOR
affiliation: Univer. Freiburg, Germany
name: Philip Maier, MD
role: STUDY_DIRECTOR
affiliation: Univer. Erlangen, Germany
name: Claus Cursiefen, MD
role: STUDY_DIRECTOR
affiliation: Univers. Freiburg
name: Thomas Reinhard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Augenklinik am St.Franzsikus Hospital, Münster
name: Arnd Heiligenhaus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univers. Mainz
name: Walter Sekundo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IROC, Zürich
name: Theo Seiler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univers Homurg, Saar
name: Atilla Osvald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univers. Mainz
name: Jan M Vetter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koller T, Seiler T. [Therapeutic cross-linking of the cornea using riboflavin/UVA]. Klin Monbl Augenheilkd. 2007 Sep;224(9):700-6. doi: 10.1055/s-2007-963492. German.
citation: 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. doi: 10.1097/ICO.0b013e3180334f78.
citation: Seiler T, Hafezi F. Corneal cross-linking-induced stromal demarcation line. Cornea. 2006 Oct;25(9):1057-9. doi: 10.1097/01.ico.0000225720.38748.58.
citation: 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. doi: 10.1016/j.jcrs.2006.11.015.