Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]

NARecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

November 20, 2023

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2028

Conditions
Corneal Transplantation
Interventions
DEVICE

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)"

Trial Locations (7)

13353

RECRUITING

Charité - Universitätsmedizin Berlin, Klinik für Augenheilkunde, Berlin

18057

RECRUITING

Klinik und Poliklinik für Augenheilkunde - Universitätsmedizin Rostock, Rostock

40225

RECRUITING

Universitätsklinikum Düsseldorf, Klinik für Augenheilkunde, Düsseldorf

50937

RECRUITING

University Hospital of Cologne, Centre for Ophthalmology, Cologne

66424

RECRUITING

Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde, Homburg

79106

RECRUITING

Universitätsklinikum Freiburg, Klinik für Augenheilkunde, Freiburg im Breisgau

80336

RECRUITING

Augenklinik des Klinikums der Universität München, München

All Listed Sponsors
collaborator

Uniklinik Köln, Zentrum für Klinische Studien

UNKNOWN

collaborator

Uniklinik Köln, Institut für Medizinische Statistik und Bioinformatik

UNKNOWN

collaborator

German Federal Ministry of Education and Research

OTHER_GOV

lead

Claus Cursiefen

OTHER