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NCT00560651 Clinical Trial

German Corneal Cross Linking Register

Keratoconus Clinical Trial

Official title:
German Corneal Cross Linking Register

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00560651
Other study ID # CCL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2007
Est. completion date November 2027

Study information
Verified date April 2024
Source St. Franziskus Hospital
Contact Suphi Taneri, MD
Phone 49-251-987-7890
Email taneri@refraktives-zentrum.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 7500
Est. completion date November 2027
Est. primary completion date November 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients diagnosed with keratokonus and treated with corneal cross Linking in Germany Exclusion Criteria: - Non-ectatic conditions

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany University of Saar Homburg
Germany Augenklinik am St. Franziskus Hospital Münster

Sponsors (1)
Lead Sponsor Collaborator
Suphi Taneri

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Keratometry yearly
Secondary Slit-lamp biomicroscopical findings yearly
Secondary Best corrected Visual Acuity Yearly
See also
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Completed NCT01691651 - Botulinum Toxin A for the Treatment of Keratoconus N/A
Completed NCT01527708 - Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas N/A
Completed NCT01527721 - Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus N/A
Recruiting NCT00841386 - Treatment of Keratoconus Using Collagen Cross-Linking Phase 2/Phase 3
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Completed NCT03235856 - Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
Completed NCT05019768 - Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS N/A
Withdrawn NCT01789333 - Higher Irradiance in Keratoconus Ectasia N/A
Completed NCT05114928 - Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.
Completed NCT03647046 - Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus N/A
Recruiting NCT04439552 - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Recruiting NCT06100939 - Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus Phase 3

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