Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]

Corneal Transplantation Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Multicenter, two armed, controlled, open randomised parallel-group study to evaluate the effect of corneal crosslinking as pre-treatment vs. no pre-treatment ahead of full-thickness penetrating corneal transplantation.

After screening of inclusion and exclusion criteria, eligible subjects will be included after obtaining informed consent. Randomisation will be performed at a 5:4 ratio.

At the baseline assessment, a slit lamp examination and photo documentation as well as LaserFlareCellMeter (if available), corneal tomography, and Slit lamp Adapted Optical Coherence Tomography (SL-OCT) measurements will be performed. In addition, visual acuity and a vision-related quality of life will be assessed.

In the intervention arm, the study intervention (CXL) will then be administered to reduce CoNV 10-8 weeks prior to corneal transplantation. Two weeks after CXL a control will be performed including AE documentation, slit lamp examination, SL-OCT, corneal tomography, visual acuity and photo documentation. The study intervention will be repeated once if insufficient (less than 50%) reduction of CoNV should be observed (4 weeks after first CXL at the earliest and 4 weeks prior to corneal transplantation at the latest). All subjects in the intervention arm will then be scheduled for corneal transplantation.

In the control arm, subjects will be directly scheduled for corneal transplantation. Corneal transplantation will be performed as standard full-thickness penetrating procedure, and the graft (7.75 mm in diameter) will be secured with 16-24 interrupted single or double running 10-0 nylon single sutures (decision by the surgeon).

Postoperatively, follow-up assessments will be performed at 3, 6, 12, 18, and 24 months for all subjects and every 6 months thereafter until the end of the trial. A slit lamp examination, AE and photo documentation as well as LaserFlareCellMeter (if available), corneal tomography, SL-OCT, and corneal endothelial cell count measurements will be performed. In addition, visual acuity and a vision-related quality of life will be assessed. ;

Related Conditions & MeSH terms

• Corneal Transplantation

• NCT number: NCT05870566
• Study type: Interventional
• Source: University of Cologne
• Contact: Claus Cursiefen, Prof. Dr.
• Phone: 00492214784300
• Email: marie.seifert@uk-koeln.de
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Completion date: September 30, 2028