Autologous Fat Augmentation of Orbital Volume 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
- 6
- 试验地点
- 1
- 主要终点
- Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique
研究概览
简要总结
After enucleation or evisceration with placement of a dermis fat graft or integrated orbital implant as a primary procedure, there can be secondary loss of orbital fat volume causing regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques for correction require open surgery to place a sheet/block of biocompatible material or a macroaggregate of fat into the orbit to augment orbital volume for permanent correction. Alternatively, hyaluronic acid-base fillers (Restylane, Radiesse) have been injected, but these have proved to be temporary. The current study seeks to show that a permanent augmentation of orbital volume can be achieved using a closed cannula injection of autologous fat.
详细描述
To date, 5 subjects have completed fat injections and 4/5 have acquired complete sets of 3 MRIs each. Data analysis has begun. The study has been extended to include 5 more subjects (total 10) to increase the number of data for analysis.
To date, the protocol has been expanded to include 10 subjects of which 6/10 have completed fat injections. The study period has been extended to include MRIs at 2 and 5 years after injection.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have developed secondary orbital fat atrophy after enucleation/evisceration with or without dermis fat grafting
- •standard sphere or integrated orbital implantation
- •phthisis bulbi are candidates
排除标准
- •class 3 or greater anesthesia risk
- •infection
- •inability to follow study protocol
研究组 & 干预措施
autologous fat grafting
There is one arm of this study. People with anophthalmic sockets and orbital atrophy are given a single session of autologous fat grafting by a closed cannula technique and are observed to measure, by MRI, the amount of fat retained at one year
干预措施: autologous fat grafting to the orbit (Procedure)
结局指标
主要结局
Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique
时间窗: 1-5 years
Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume
次要结局
未报告次要终点
研究者
Donald M Fox, MD
Fox, Donald Munro, M.D.
Fox, Donald Munro, M.D., P.C.