UV Light-mediated Corneal Crosslinking as (Lymph)Angioregressive Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]
Led by Claus Cursiefen · Updated on 2024-10-21
110
Participants Needed
7
Research Sites
52 weeks
Total Duration
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Brief Title
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Your Study Journey
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Sponsors
C
Claus Cursiefen
Lead Sponsor
U
Uniklinik Köln, Zentrum für Klinische Studien
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating corneal crosslinking (CXL) as a pre-treatment before full-thickness penetrating corneal transplantation in patients with pathologically prevascularized corneas. The study aims to improve graft survival by reducing pathological corneal neovascularization (CoNV) before transplantation. This multicenter, randomized, controlled trial compares the outcomes of patients receiving CXL before surgery to those undergoing transplantation without pre-treatment.
Participants in the intervention group will receive corneal crosslinking 8 to 10 weeks prior to transplantation, with a possible repeat treatment if less than 50% reduction of CoNV is observed. The control group will proceed directly to transplantation without CXL. Corneal transplantation involves securing the graft with nylon sutures, and in the intervention arm, fine needle diathermy may be used to occlude residual vessels if needed. In contrast, fine needle diathermy is not performed in the control group to avoid risks.
During the study, participants will undergo baseline examinations including slit lamp assessments, corneal tomography, optical coherence tomography, visual acuity testing, and quality-of-life questionnaires. Follow-up visits occur at 3, 6, 12, 18, and 24 months after transplantation, with repeated evaluations and documentation to monitor graft function, CoNV regression, rejection episodes, and vision outcomes. Participants can contact the study site anytime with concerns, and additional visits may be scheduled as needed. The primary outcome is the time to first episode of endothelial graft rejection within 24 months post-transplantation.
CONDITIONS
Brief Title
Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]
Adult male or female subjects aged 18 years or older
At least 2 corneal quadrants covered by pathological corneal neovascularization
Written informed consent obtained prior to study procedures
Cooperative attitude to follow study procedures
Only one eye included in case of bilateral disease
Steroid responders with controlled regimen or local/systemic therapy can participate
You will not qualify if you...
Less than 2 corneal quadrants covered by pathological neovascularization
Corneal stromal thickness below 400 bcm except in central 8 mm zone
Active or suspected intraocular inflammation
Active corneal ulceration
Compromised eyelid mobility or symblepharon
Allergy or intolerance to riboflavin or ultraviolet light
Contraindications to treatment or surgical protocols
Clinically significant or unstable concurrent medical conditions
Rheumatic diseases on systemic immunosuppressive medication
Unable to comply with study protocol or understand study scope
Participation in another investigational drug trial within 4 weeks
HIV positive status
Known substance abuse
Psychiatric or other medical conditions interfering with treatment
Sponsor employees or relatives of investigators
Pregnant or nursing women
Persons held in legal or official institutions
Dysregulated glaucoma with intraocular pressure over 25 mmHg despite therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Corneal Crosslinking Pretreatment
Duration - Up to 6 weeks before transplantation
Participants in the intervention group receive corneal crosslinking treatment to reduce corneal neovascularization 8 to 10 weeks before corneal transplantation. The treatment may be repeated once if insufficient response is observed.
1 to 2 visits including treatment and follow-up
Corneal Transplantation
Duration - 1 day
Participants undergo standard full-thickness penetrating corneal transplantation surgery.
1 visit (surgery day)
Post-operative Follow-up
Duration - 24 months
Participants are monitored after surgery with assessments of graft survival, visual acuity, and ocular health at regular intervals.
Visits at 3, 6, 12, 18, and 24 months post-transplant
Trial Site Locations
Total: 7 locations
1
Augenklinik des Klinikums der Universität München
München, Bavaria, Germany, 80336
Actively Recruiting
2
University Hospital of Cologne, Centre for Ophthalmology
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
3
Universitätsklinikum Düsseldorf, Klinik für Augenheilkunde
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
4
Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde
Homburg, Saarland, Germany, 66424
Actively Recruiting
5
Charité - Universitätsmedizin Berlin, Klinik für Augenheilkunde
Berlin, Germany, 13353
Actively Recruiting
6
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
7
Klinik und Poliklinik für Augenheilkunde - Universitätsmedizin Rostock
UV light-mediated corneal crosslinking as (lymph)angioregressive pretreatment to promote graft survival after subsequent high-risk corneal transplantation (CrossCornealVision): protocol for a multicenter, randomized controlled trial.