Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 4
- 主要终点
- the primary outcome is the endothelial cell density (ECD) of the corneal grafts.
研究概览
简要总结
At present, all commercially available corneal organ culture media contain foetal calf serum (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for corneal cell survival but are problematic because they theoretically have risk of anthropozoonosis transmission, especially for new variant of CJD and the variability between FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo validation of a new medium free compound animal. We proved its superiority over conventional medium containing 2% FCS for endothelial cell survival during the storage time. The goal of this clinical trial is now to assess its superiority in patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and female patients
- •over 18 years of age
- •Clinically proven corneal disease
- •Registered on the French National waiting list (GLAC)
- •Patient informed consent
- •Patient who needs a 8.25mm of diameter perforating keratoplasty, either isolated or combined with lens surgery
- •Low immune rejection risk (< 2 quadrants of neovascularization, no previous history of herpetic keratitis nor graft rejection)
- •No previous history of glaucoma or elevated intra ocular pressure (>22 mm
排除标准
- •Patient is unlikely to comply with the requirements of the protocol
研究组 & 干预措施
organ culture medium containing 2% of fœtal calf serum
Patients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum
干预措施: corneal graft (Procedure)
Animal Compound Free Medium
Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium
干预措施: corneal graft (Procedure)
结局指标
主要结局
the primary outcome is the endothelial cell density (ECD) of the corneal grafts.
时间窗: one year after graft
次要结局
未报告次要终点