Safety and Efficacy of Brief Intraoperative Corneal Endothelial Graft Incubation in Plasma Rich in Growth Factors (PRGF) for Reducing Postoperative Endothelial Cell Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Change in endothelial cell percentage
研究概览
简要总结
The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing endothelial keratoplasty (DSEK or DMEK) at the Bascom Palmer Eye Institute or Price Vision Group, using corneal graft tissue within 14 days of preservation
排除标准
- •History of corneal transplantation in the study eye, Best corrected visual acuity (BCVA) worse than 20/40 in the contralateral eye, systemic immunosuppression, previous intraocular surgical procedures (other than cataract surgery) such as glaucoma tubes or silicone oil.
- •The following special populations will be excluded.
- •Adults unable to consent
- •Pregnant women
- •Prisoners
研究组 & 干预措施
PRGF group
Participants tissue will be incubated in plasma rich in growth factors prior to endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.
干预措施: PRGF (Biological)
Control group
Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.
干预措施: Endothelial keratoplasty (Procedure)
PRGF group
Participants tissue will be incubated in plasma rich in growth factors prior to endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.
干预措施: Endothelial keratoplasty (Procedure)
结局指标
主要结局
Change in endothelial cell percentage
时间窗: Baseline, 6 months
Central corneal endothelial cell percentage will be assessed by specular microscopy and compared with the baseline donor endothelial cell percentage measured by the provider eye bank to determine endothelial cell changes.
次要结局
- Change in Endothelial cell density(Baseline, up to 12 months)
- Number of re-bubbling for graft attachment(Up to 2 months)
- Visual acuity measured by snellen chart(Up to 12 months)
- Corneal endothelial cell density(Up to 12 months)
研究者
Alfonso Sabater
Associate Professor of Clinical Ophthalmology
University of Miami