110
Participants
Start Date
November 20, 2023
Primary Completion Date
September 30, 2027
Study Completion Date
September 30, 2028
Corneal Crosslinking
"Riboflavin isotonic, 0,1 % Vitamin B2, with Dextran 20,0%, for epi-off procedure or Riboflavin isotonic 0,1% (Vitamin B2), 1,1% HPMC without Dextran for epi-off) 0.1% riboflavin-5-phosphate and 20% dextran T-500) will be applied to the cornea after epithelial debridement every 2 min for 10 minutes before irradiation and every 2 minutes during the course of a 10 minute exposure to 365 nm UV-A with an irradiance rate of 9 mW/cm2. This dose, mode and scheme of the intervention follows the internationally recognized accelerated CXL protocol (Elbaz et al. 2014). The data existing shows equivalent outcome regarding efficacy and safety compared to the standard protocol. To avoid any damage to the limbal stem cells, the limbus will not be irradiated during the procedure, as a CXL device (with maximal diameter of 11 mm) will be used. Furthermore, the limbal area will additionally be protected by a custom-cut LSC protection shield. (Protocol V04\_0 Page 45-46)"
RECRUITING
Charité - Universitätsmedizin Berlin, Klinik für Augenheilkunde, Berlin
RECRUITING
Klinik und Poliklinik für Augenheilkunde - Universitätsmedizin Rostock, Rostock
RECRUITING
Universitätsklinikum Düsseldorf, Klinik für Augenheilkunde, Düsseldorf
RECRUITING
University Hospital of Cologne, Centre for Ophthalmology, Cologne
RECRUITING
Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde, Homburg
RECRUITING
Universitätsklinikum Freiburg, Klinik für Augenheilkunde, Freiburg im Breisgau
RECRUITING
Augenklinik des Klinikums der Universität München, München
Uniklinik Köln, Zentrum für Klinische Studien
UNKNOWN
Uniklinik Köln, Institut für Medizinische Statistik und Bioinformatik
UNKNOWN
German Federal Ministry of Education and Research
OTHER_GOV
Claus Cursiefen
OTHER