Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]
NCT ID: NCT05870566
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2023-11-20
2028-09-30
Brief Summary
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Detailed Description
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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. (Protocol V04\_0 Page 37) 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. Concomitant medication will be documented. Macula OCT will be performed if deemed necessary. 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 prior to corneal transplantation at the latest). All subjects in the intervention arm will then undergo 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 (6.5 - 8.25 mm 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 (postoperative visits at these time points are standard of care). A slit lamp examination, concomitant medication, 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. Macula OCT will be performed if deemed necessary. If a subject has any complaints, he or she can contact the responsible trial site at any time.
After consultation with the investigator, additional visits can be scheduled. (Protocol V04\_0 Page 50)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
Corneal Crosslinking
Riboflavin isotonic, 0,1 % Vitamin B2, with Dextran 20,0%, for epi-off procedure or Riboflavin isotonic 0,1% (Vitamin B2), 1,1% HPMC without Dextran for epi-off) 0.1% riboflavin-5-phosphate and 20% dextran T-500) will be applied to the cornea after epithelial debridement every 2 min for 10 minutes before irradiation and every 2 minutes during the course of a 10 minute exposure to 365 nm UV-A with an irradiance rate of 9 mW/cm2. This dose, mode and scheme of the intervention follows the internationally recognized "accelerated CXL protocol" (Elbaz et al. 2014). The data existing shows equivalent outcome regarding efficacy and safety compared to the standard protocol. To avoid any damage to the limbal stem cells, the limbus will not be irradiated during the procedure, as a CXL device (with maximal diameter of 11 mm) will be used. Furthermore, the limbal area will additionally be protected by a custom-cut LSC protection shield. (Protocol V04\_0 Page 45-46)
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)
No interventions assigned to this group
Interventions
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Corneal Crosslinking
Riboflavin isotonic, 0,1 % Vitamin B2, with Dextran 20,0%, for epi-off procedure or Riboflavin isotonic 0,1% (Vitamin B2), 1,1% HPMC without Dextran for epi-off) 0.1% riboflavin-5-phosphate and 20% dextran T-500) will be applied to the cornea after epithelial debridement every 2 min for 10 minutes before irradiation and every 2 minutes during the course of a 10 minute exposure to 365 nm UV-A with an irradiance rate of 9 mW/cm2. This dose, mode and scheme of the intervention follows the internationally recognized "accelerated CXL protocol" (Elbaz et al. 2014). The data existing shows equivalent outcome regarding efficacy and safety compared to the standard protocol. To avoid any damage to the limbal stem cells, the limbus will not be irradiated during the procedure, as a CXL device (with maximal diameter of 11 mm) will be used. Furthermore, the limbal area will additionally be protected by a custom-cut LSC protection shield. (Protocol V04\_0 Page 45-46)
Eligibility Criteria
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Inclusion Criteria
\- Pathologically prevascularized cornea with need for corneal transplantation
* 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
* 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)
18 Years
ALL
No
Sponsors
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Uniklinik Köln, Zentrum für Klinische Studien
UNKNOWN
Uniklinik Köln, Institut für Medizinische Statistik und Bioinformatik
UNKNOWN
German Federal Ministry of Education and Research
OTHER_GOV
Claus Cursiefen
OTHER
Responsible Party
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Claus Cursiefen
Prof. Dr.
Principal Investigators
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Claus Cursiefen, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Cologne, Centre for Ophthalmology
Locations
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Augenklinik des Klinikums der Universität München
München, Bavaria, Germany
University Hospital of Cologne, Centre for Ophthalmology
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Düsseldorf, Klinik für Augenheilkunde
Düsseldorf, North Rhine-Westphalia, Germany
Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde
Homburg, Saarland, Germany
Charité - Universitätsmedizin Berlin, Klinik für Augenheilkunde
Berlin, , Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, , Germany
Klinik und Poliklinik für Augenheilkunde - Universitätsmedizin Rostock
Rostock, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Wiedemann J, Hos D, Limburg E, Zettelmeyer U, Schiller P, Franklin J, Bachmann B, Bohringer D, Dietrich-Ntoukas T, Fuchsluger TA, Geerling G, Lang SJ, Mayer WJ, Priglinger S, Reinhard T, Seitz B, Cursiefen C. 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. Trials. 2024 Mar 6;25(1):169. doi: 10.1186/s13063-024-08011-1.
Other Identifiers
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01KG2127
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Uni-Koeln-5045
Identifier Type: -
Identifier Source: org_study_id
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