The trial evaluates the effect of corneal crosslinking as pre-treatment before corneal transplantation. The goal is to improve graft survival by reducing pathological vessels through pre-treatment.
Written informed consent by subject and/or witness prior to any study-related procedures
Adult male and female subjects ≥ 18 years old
≥ 2 corneal quadrants covered by pathological corneal neovascularization
Absence of other clinical contraindications to any part or product of the treatment plan
< 2 corneal quadrants covered by pathological neovascularization
Corneal stromal thickness below 400 μm (except in the central 8 mm zone which will be replaced later by a new corneal transplant with new endothelium); peripheral stromal thinning below 400 μm in weakened recipient areas is acceptable for CXL if not affecting more than 50% of the corneal circumference (allowing for later endothelial repopulation)
Active or suspected intraocular inflammation
Active corneal ulceration
Parallel
Corneal Crosslinking
DeviceRiboflavin 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)
First episode of endothelial graft rejection
Endothelial graft rejection episode is defined by at least 2 of the following criteria: new endothelial precipitates, new anterior chamber cells/flare, new focal or diffuse edema of the graft. All signs will be analyzed by slit lamp examination, on standardized digital slit lamp pictures, by LaserFlareCellMeter (if available), SL-OCT and corneal tomography. (Protocol V04\_0 Page 48)
Regression of CoNV
Assessed by morphometrical analysis of the corneal area covered by CoNV prior to and 2-4 weeks after each CXL, prior to transplantation and at 3, 6, 12, 18 and 24 months using digital standardized slit lamp images and an independent reading center (CORIC). Note: the corneal area covered by CoNV will also be measured in control patients (not receiving angioregressive CXL) at all visits to determine the natural course of CoNV. (Protocol V04\_0 Page 48)
Regression of CoNV
Number of CXL procedures needed for \>50% regression of CoNV
Recurrence of CoNV
After CXL and after transplantation
Overall functional graft survival rate
Functional survival of graft will be assessed at every follow-up visit after transplantation clinically and using digital slit lamp pictures, SL-OCT and corneal tomography (for graft thickness) as well as endothelial cell counts
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Claus Cursiefen
Lead sponsor
University of Cologne
Sponsor institution
Uniklinik Köln, Zentrum für Klinische Studien
Collaborator
Uniklinik Köln, Institut für Medizinische Statistik und Bioinformatik
Collaborator
German Federal Ministry of Education and Research
Collaborator
