Improving corneal transplant success with pre-treatment
UV Light-mediated Corneal Crosslinking as (Lymph)Angioregressive Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]
This study tests if a treatment called corneal crosslinking can help improve the success of corneal transplants for patients at high risk of complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cologne Academic / other |
| Locations | 7 sites (München, Bavaria and 6 other locations) |
| Trial ID | NCT05870566 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of corneal crosslinking as a pre-treatment to enhance graft survival in patients undergoing high-risk corneal transplantation. It is a multicenter, controlled, open randomized parallel-group study comparing outcomes between patients receiving corneal crosslinking and those who do not prior to their transplant. Eligible participants will undergo a series of assessments, including visual acuity and corneal imaging, before and after the intervention. The aim is to reduce pathological neovascularization in the cornea before transplantation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically prevascularized corneas requiring transplantation.
Not a fit: Patients with less than two quadrants of corneal neovascularization or insufficient corneal thickness may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the success rates of corneal transplants for patients with prevascularized corneas.
How similar studies have performed: Previous studies have shown promising results with corneal crosslinking in improving graft outcomes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Medical condition or disease to be investigated: \- Pathologically prevascularized cornea with need for corneal transplantation Further inclusion criteria: * 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 Criteria: * \< 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)
Where this trial is running
München, Bavaria and 6 other locations
- Augenklinik des Klinikums der Universität München — München, Bavaria, Germany (Recruiting)
- University Hospital of Cologne, Centre for Ophthalmology — Cologne, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinikum Düsseldorf, Klinik für Augenheilkunde — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde — Homburg, Saarland, Germany (Recruiting)
- Charité - Universitätsmedizin Berlin, Klinik für Augenheilkunde — Berlin, Germany (Recruiting)
- Universitätsklinikum Freiburg, Klinik für Augenheilkunde — Freiburg im Breisgau, Germany (Recruiting)
- Klinik und Poliklinik für Augenheilkunde - Universitätsmedizin Rostock — Rostock, Germany (Recruiting)
Study contacts
- Principal investigator: Claus Cursiefen, Prof. Dr. — University Hospital of Cologne, Centre for Ophthalmology
- Study coordinator: Claus Cursiefen, Prof. Dr.
- Email: marie.seifert@uk-koeln.de
- Phone: 00492214784300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.