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German Corneal Cross Linking Register

NCT00560651 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 7500

Last updated 2025-01-10

No results posted yet for this study

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

Conditions

  • Keratoconus

Interventions

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

Sponsors & Collaborators

  • Suphi Taneri

    lead OTHER

Principal Investigators

  • Suphi Taneri, MD · Augenklinik am St. Franziskus Hospital

  • Berthold Seitz, MD · University of Homburg, Saar, Germany

  • Philip Maier, MD · Univer. Freiburg, Germany

  • Claus Cursiefen, MD · Univer. Erlangen, Germany

  • Thomas Reinhard, MD · Univers. Freiburg

  • Arnd Heiligenhaus, MD · Augenklinik am St.Franzsikus Hospital, Münster

  • Walter Sekundo, MD · Univers. Mainz

  • Theo Seiler, MD · IROC, Zürich

  • Atilla Osvald, MD · Univers Homurg, Saar

  • Jan M Vetter, MD · Univers. Mainz

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2024-11-30
Completion
2027-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00560651 on ClinicalTrials.gov