A Randomized, Observer-masked, Clinical Trial Comparing the Neusidl Corneal Inserter Corneal Transplant Technique to the Standard Forceps Insertion Technique for Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Decrease in Endothelial Cell Density From Baseline Over Time
研究概览
简要总结
This project compares the Neusidl Corneal Injector (NCI) device developed by Fischer Surgical, Inc. for the delivery of tissue into the eye in DSAEK surgery to the current standard forceps insertion DSAEK technique. The goal of this study is to examine the damage to the corneal endothelium resulting from the use of the NCI device in comparison to the use of our standard surgical DSAEK technique over time.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 and over
- •A diagnosis of Fuchs' Corneal Endothelial Dystrophy
排除标准
- •Under age 21
- •Diagnosis of advanced glaucomatous disease
- •Diagnosis of significant retinal disease
- •Diagnosis of any other corneal dystrophy
- •Previous corneal transplant surgery
- •Previous glaucoma surgery
- •Previous retinal surgery
- •Previous refractive surgery
结局指标
主要结局
Decrease in Endothelial Cell Density From Baseline Over Time
时间窗: 6, 12, 24, and 60 Months
Endothelial cell density (ECD) will be captured at each follow-up visit using a non-contact specular microscope. % Cell reduction from pre-operative baseline ECD will be calculated for each patient, and compared between treatment arms to evaluate each instrument's effect on long-term post-operative endothelial cell density.
次要结局
- Adverse events(Any time during follow-up period (5 years))