UV Light-mediated Corneal Crosslinking as (Lymph)Angioregressive Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Germany
Charité - Universitätsmedizin Berlin, Klinik für Augenheilkunde
RECRUITING
Berlin
University Hospital of Cologne, Centre for Ophthalmology
RECRUITING
Cologne
Universitätsklinikum Düsseldorf, Klinik für Augenheilkunde
RECRUITING
Düsseldorf
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
RECRUITING
Freiburg Im Breisgau
Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde
RECRUITING
Homburg
Augenklinik des Klinikums der Universität München
RECRUITING
München
Klinik und Poliklinik für Augenheilkunde - Universitätsmedizin Rostock
RECRUITING
Rostock
Contact Information
Primary
Claus Cursiefen, Prof. Dr.
marie.seifert@uk-koeln.de
00492214784300
Backup
Deniz Hos, Dr.
deniz.hos@uk-koeln.de
004922147898896
Time Frame
Start Date: 2023-11-20
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 110
Treatments
Experimental: Corneal Crosslinking (CXL)
In the intervention group, the study intervention (CXL) will be administered to stabilize therecipient cornea (which remains in place after penetrating keratoplasty) and to reduce CoNV 8 to 10 weeks prior to corneal transplantation. The study intervention will be repeated once (after 4 weeks prior to transplantation at the latest at the earliest) if insufficient (less than 50%) reduction of CoNV should be observed (to be decided by the respective surgeon). (Protocol V04\_0 Page 45) Corneal transplantation will be performed as standard full-thickness penetrating procedure, and the graft (6.5 to 8.25 in diameter) will be secured with 16-24 interrupted single or 2 double running 10-0 nylon sutures (decision by the surgeon). In case of residual CoNV in the intervention group, visible vessels will may be thermally occluded by fine needle diathermy to avoid intraoperative bleeding and reduce complications (to be decided by the respective surgeon at start of surgery). (Protocol V04\_0 Page 46)
No_intervention: control group
In the control group subjects will be directly scheduled for corneal transplantation without previous CXL. A sham CXL procedure will not be performed. Corneal transplantation will be performed as standard full-thickness penetrating procedure, and the graft (6.5 to 8.25 in diameter) will be secured with 16-24 interrupted single or 2 double running 10-0 nylon sutures (decision by the surgeon). In case of residual CoNV in the intervention group, visible vessels will may be thermally occluded by fine needle diathermy to avoid intraoperative bleeding and reduce complications (to be decided by the respective surgeon at start of surgery). In the control group, no fine needle diathermy will be performed, as this procedure combined with corneal transplantation in previously non-crosslinked eyes might lead to fistulas and thereby to potential intraocular infections. (Protocol V04\_0 Page 46)
Related Therapeutic Areas
Sponsors
Leads: Claus Cursiefen
Collaborators: Uniklinik Köln, Zentrum für Klinische Studien, Uniklinik Köln, Institut für Medizinische Statistik und Bioinformatik, German Federal Ministry of Education and Research

This content was sourced from clinicaltrials.gov