UV Light-mediated Corneal Crosslinking as (Lymph)Angioregressive Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 14
- 主要终点
- First episode of endothelial graft rejection
研究概览
简要总结
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.
详细描述
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. (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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •< 2 corneal quadrants covered by pathological neovascularization
- •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)
结局指标
主要结局
First episode of endothelial graft rejection
时间窗: within 24 months after transplantation
Endothelial graft rejection episode is defined by at least 2 of the following criteria: new endothelial precipitates, new anterior chamber cells/flare, new focal or diffuse edema of the graft. All signs will be analyzed by slit lamp examination, on standardized digital slit lamp pictures, by LaserFlareCellMeter (if available), SL-OCT and corneal tomography. (Protocol V04_0 Page 48)
次要结局
- Regression of CoNV(before transplantation)
- Recurrence of CoNV(after CXL and 3, 6, 12, 18 and 24 months after transplantation)
- Overall functional graft survival rate(3, 6, 12, 18 and 24 months after transplantation)
- Absence of rejection-related graft failure(3, 6, 12, 18 and 24 months after transplantation)
- Best corrected visual acuity (BCVA)(Prior to CXL, prior to transplantation and after 3, 6, 12, 18, and 24 months)
- Vision-related quality of life(Prior to CXL, prior to transplantation and after 3, 6, 12, 18, and 24 months)
- Active infectious keratitis or corneal ulceration(every study visit)
- Graft dehiscence(3, 6, 12, 18 and 24 months after transplantation)
- Delayed epithelial wound healing(3, 6, 12, 18 and 24 months after transplantation)
研究者
Claus Cursiefen
Prof. Dr.
University of Cologne