Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet's Stripping Endothelial Keratoplasty (DSEK)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 6-month post-operative endothelial cell density
研究概览
简要总结
The purpose of this study is to determine whether the surgical outcomes in patients undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of an insertion device over the traditional forceps insertion method.
详细描述
Laboratory studies and clinical functionality tests have shown that the study device safely forms the tissue without creasing or folding. It allows the allograft tissue to safely pass into the anterior chamber without compression, crushing, or squeezing the endothelial cells.
The device provides continuous irrigation into the eye to prevent collapse of the anterior chamber during insertion. Our study will focus on the safety and efficacy of the novel instrument over the current method of insertion (forceps).
FDA has classified the device as Class I, Reserved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Fuchs endothelial dystrophy or bullous keratopathy determined to need a corneal transplant for visual restoration.
排除标准
- 未提供
结局指标
主要结局
6-month post-operative endothelial cell density
时间窗: 6-months post-operatively
次要结局
- 12-month post-operative endothelial cell density(12-months post-operatively)