Claus Cursiefen
Claus Cursiefen
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.
Corneal Transplantation
Corneal Crosslinking
Not Applicable
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.
Study Type : | Interventional |
Estimated Enrollment : | 110 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | UV Light-mediated Corneal Crosslinking as (Lymph)Angioregressive Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision] |
Actual Study Start Date : | November 20, 2023 |
Estimated Primary Completion Date : | September 30, 2027 |
Estimated Study Completion Date : | September 30, 2028 |
Arm | Intervention/treatment |
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Experimental: Corneal Crosslinking (CXL) The study intervention (CXL) will be administered to reduce CoNV 10 to 12 weeks prior to corneal transplantation. It will be repeated once if insufficient reduction of CoNV should be observed (i.e. there are still corneal neovessels present; to be decided by the respective surgeon). The second intervention will be applied 2 to 4 weeks after the first CXL and at least 4 weeks prior to transplantation). Corneal transplantation will be performed as standard full-thickness penetrating procedure, and the graft (individualized size between 6.5 to 8.25 mm in diameter) will be secured with 16-24 interrupted single or double running 10-0 nylon sutures (decision by the surgeon). In case of residual CoNV at the day of keratoplasty, fine needle diathermy will be performed using a 10/0 stainless steel needle. |
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No Intervention: control group Subjects will be directly scheduled for corneal transplantation without previous CXL. Corneal transplantation will be performed as standard full-thickness penetrating procedure, and the graft (individualized size between 6.5 to 8.25 mm in diameter) will be secured with 16-24 interrupted single or double running 10-0 nylon sutures (decision by the surgeon). 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. |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University Hospital of Cologne, Centre for Ophthalmology
Cologne, NRW, Germany, 50937