German Corneal Cross Linking Register
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Suphi Taneri, MD
- Phone Number: 49-251-987-7890
- Email: taneri@refraktives-zentrum.de
Study Contact Backup
- Name: Anika Förster, MSc
- Phone Number: 49-251-987-7890
- Email: foerster@refraktives-zentrum.de
Study Locations
-
-
-
Homburg, Germany, 66421
- University of Saar
-
Münster, Germany, 48145
- Augenklinik am St. Franziskus Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed with keratokonus and treated with corneal cross Linking in Germany
Exclusion Criteria:
- Non-ectatic conditions
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
1
Cross linked eyes
|
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:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Acuity
Time Frame: 172 to 3396 days
|
Corrected Visual Acuity after crosslinking at the latest follow up examination
|
172 to 3396 days
|
|
Postoperative K Max
Time Frame: 172 to 3396 days
|
K max after Crosslinking
|
172 to 3396 days
|
|
Sphere
Time Frame: 172 to 3396 days
|
Sphere values after crosslinking at lastest-follow-up
|
172 to 3396 days
|
|
Cylinder
Time Frame: 172 to 3396 days
|
Refractive cylinder after Crosslinking at latest follow-up
|
172 to 3396 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Slit-lamp biomicroscopical findings
Time Frame: yearly
|
yearly
|
|
Best corrected Visual Acuity
Time Frame: Yearly
|
Yearly
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endothelial Cell Density
Time Frame: 172 to 3396 days
|
Endothelial cell density after Crosslinking at latest follow-up
|
172 to 3396 days
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Keratoconus
- Corneal Diseases
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Therapeutics
- Drug Therapy
- Amides
- beta-Lactams
- Lactams
- Cephalosporins
- Thiazines
- Combined Modality Therapy
- Phototherapy
- Photochemotherapy
- Cephalexin
- Cefaclor
- Corneal Cross-Linking
Other Study ID Numbers
Other Study ID Numbers
- CCL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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