Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]
UV Light-mediated Corneal Crosslinking as (Lymph)Angioregressive Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]
Claus Cursiefen
110 participants
Nov 20, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- Medical condition or disease to be investigated:
- \- Pathologically prevascularized cornea with need for corneal transplantation
- 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
- A cooperative attitude to follow up the study procedures
- In case of bilateral disease only one eye will be included
- Steroid responders with adequate control regiment or local/systemic therapy can be included
Exclusion Criteria20
- < 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
- Compromised eyelid mobility and/or symblepharon
- Allergy, sensitivity or intolerance to riboflavin or UV
- Contraindications, other than steroid response to the local or systemic antibiotics and/or corticosteroids (other than steroid response) foreseen by the protocol
- Contraindications to the surgical protocol
- Clinically significant or unstable concurrent disease or other medical condition affecting grafting procedure
- Rheumatic diseases treated with systemic immunosuppressive medication
- Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study procedures and treatments
- Participation in another clinical trial where an investigational drug was received less than 4 weeks prior to screening visit
- Positive for human immunodeficiency virus (HIV)
- Known abuse of alcohol, drugs, or medicinal products
- Evidence of any other medical conditions (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the subject's compliance, or place the subject at high risk of complications related to the treatment
- Employees of the sponsor, or employees or relatives of the investigator.
- Pregnant women and nursing mothers as corneal transplantation in standard care is performed under general anaesthesia
- Persons held in an institution by legal or official order
- Dysregulated glaucoma with IOP > 25 mmHg at baseline despite local therapy
- (Protocol V04_0 Page 43)
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Interventions
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)
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05870566