In Vitro and Clinical Comparison of Corneal Grafts Cultured in Serum Free Medium or Standard Serum Supplemented Medium in Patients With Degeneration of the Corneal Endothelium
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure
研究概览
简要总结
The goal of this clinical trial is to compare the quality of corneal grafts cultured in a serum-free culture medium with a defined composition versus corneal grafts cultured in a standard serum supplemented culture medium transplanted in patients with decompensated corneal dystrophy
详细描述
The primary objective of this clinical trial is to test the equivalence of the quality of the corneal grafts cultured under serum free conditions to corneal grafts cultured in the Minimal Essential Medium supplemented with 2% fetal calf serum, based on a parallel comparison of the endothelial cell density of paired corneal grafts deriving from single donors at different time points before and after the grafting procedure. In addition, the safety of the clinical use of corneal grafts cultured in both media will be determined. The graft survival rate during the follow-up period will be quantified in regard to immune mediated graft rejection and non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 50 and 85 years of age
- •Clinically proven Fuchs corneal dystrophy or secondary decompensation the corneal endothelium (e. g. after surgical intervention in the anterior segment of the eye)
- •Patient informed consent
排除标准
- •Previous penetrating keratoplasty
- •Corneal neovascularisation
- •Pathologic changes in the anterior segment of the eye (anterior / posterior synechiae, uveitis)
- •Infectious diseases of the cornea
- •Neurodermitis
- •Participation of the patient in another clinical trial within the last four weeks that precede the recruitment
- •The patient is unlikely to comply with the requirements of the protocol
- •Previous or current abuse of medications, narcotics or alcohol
- •Pregnancy
结局指标
主要结局
The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure
时间窗: The measurment will be performed prior to and 1, 4, 12, 24, 36, 48 and 60 months after the transplantation
次要结局
- Secondary study outcomes are immune mediated graft rejection, non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.(1,4,12, 24, 36, 48 and 60 month after the transplantation)