Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)
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
- Orbital volume
研究概览
简要总结
immobilization of yoked extra-ocular muscles in the anophthalmic orbit, in conjunction with platelet-rich-plasma, will improve integration of viable adipocytes injected into orbital fat
详细描述
Immobilization of tissue (graft, graft bed) is a prerequisite for tissue integration. Since yoked extra-ocular muscles continue to be stimulated by movements of the seeing eye after fat injection into the anophthalmic orbit, the use of botulinum toxin(s) can be used to prevent movement of the orbital tissue bed(s) and improve anchoring of injected fat. Platelet rich plasma may also improve fat cell anchoring by the action of fibrin on the adhesion process. This innovation builds on the results of IRB protocols 10.27 and 12.01 as registered with Clinical Trials.gov
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •anophthalmic enophthalmos in subjects within a 50 mile radius of New York City, grade 0-1 anesthesia risk, ages 21-75
排除标准
- •radiated orbits
研究组 & 干预措施
fat, PRP, botulinum toxin
Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
干预措施: fat, PRP, botulinum toxin (Procedure)
fat, PRP, botulinum toxin
Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
干预措施: botulinum toxin (Drug)
fat, PRP, botulinum toxin
Fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
干预措施: PRP (Device)
结局指标
主要结局
Orbital volume
时间窗: one year
Augmentation of orbital volume accessed with clinical photographs and non-contrast MRI
次要结局
未报告次要终点