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NCT05870566 | Recruiting | Corneal Transplantation


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

Claus Cursiefen

Information provided by (Responsible Party):

Claus Cursiefen

Brief 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.

Condition or disease

Corneal Transplantation

Intervention/treatment

Corneal Crosslinking

Phase

Not Applicable

Detailed 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.

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

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.

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
Criteria
Inclusion Criteria
  • Pathologically prevascularized cornea with need for corneal transplantation
  • Written informed consent by subject and/or witness/legal representative, 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
Exclusion Criteria
  • < 2 corneal quadrants covered by pathological neovascularization
  • Corneal stromal thickness below 400 μm
  • Active or suspected intraocular inflammation
  • Active corneal ulceration
  • Compromised eyelid mobility and/or symblepharon
  • Allergy, sensitivity or intolerance to riboflavin or UV
  • Contraindications to the local or systemic antibiotics and/or corticosteroids foreseen by the protocol
  • Contraindications to the surgical protocol
  • Clinically significant or unstable concurrent disease or other medical condition affecting grafting procedure
  • Rheumatic diseases
  • Subjects unlikely to comply with the study protocol
  • 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 anesthesia
  • Persons held in an institution by legal or official order

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

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Germany, NRW

University Hospital of Cologne, Centre for Ophthalmology

Cologne, NRW, Germany, 50937

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