German Corneal Cross Linking Register
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ClinicalTrials.gov Identifier: NCT00560651 |
Recruitment Status
:
Recruiting
First Posted
: November 20, 2007
Last Update Posted
: October 18, 2016
|
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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 or disease | Intervention/treatment |
---|---|
Keratoconus | Procedure: CCL (Corneal Cross Linking) |
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 |

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

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients diagnosed with keratokonus and treated with corneal cross Linking in Germany
Exclusion Criteria:
- Non-ectatic conditions

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
Contact: Suphi Taneri, MD | 49-251-987-7890 | taneri@refraktives-zentrum.de | |
Contact: Saskia Oehler | 49-251-987-7890 | oehler@refraktives-zentrum.de |
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 |
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 |
Additional Information:
Publications:
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 Key Record Dates |
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 |