Autologous Fat Grafting to Anophthalmic Sockets With PRP (Platelet Rich Plasma) Using a Closed Cannula Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Improved retention of autologous fat injected into anophthalmic sockets
研究概览
简要总结
After people lose an eye, for whatever reason, they often experience fat atrophy of the tissues in the orbit. This leads to a sunken appearance that is often not correctable by a cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/ invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own disadvantages. This study seeks to demonstrate an improvement in the retention of injected autologous fat by mixing in autologous PRP (platelet rich plasma).
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •anophthalmos, orbital atrophy -
排除标准
- •poor anesthesia risk, people outside a 100 mile radius of New York City
研究组 & 干预措施
fat grafting with PRP to anophthalmic orbits
There is only one arm to this study. People with orbital atrophy and loss of an eye are to be injected with autologous fat mixed with autologous PRP (platelet rich plasma) and observed for at least one year for evidence of retention of the injected fat
干预措施: autologous fat grafting with PRP to anophthalmic orbits (Procedure)
结局指标
主要结局
Improved retention of autologous fat injected into anophthalmic sockets
时间窗: 1-5 yrs
Non contrast MRIs of the orbits are obtained before, immediately after, and one year after injection of autologous fat mixed with autologous PRP (platelet rich plasma)
次要结局
未报告次要终点