Autologous Intravitreal Plasmin and Fibrinolytic System of Vitreous in Patient With Macular Edema
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Visual acuity after intravitreal autologous plasmin
研究概览
简要总结
The purpose of this study is to evaluate in a prospective study the efficacy of intravitreal autologous plasmin enzyme in macular edema and to analyze the fibrinolytic system in vitreous body.
详细描述
Autologous plasmin enzyme has been used to liquefy the gel structure of the vitreous body and to decrease the adherence of the posterior vitreous cortex to the inner limiting membrane in clinical studies. The investigators performed intravitreal autologous plasmin enzyme for macular edema. in addition, the investigators collected vitreous body in macular edema and analyzed fibrinolytic system.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eyes with macular edema
- •those who showed poor outcomes in visual acuity or macular thickness after grid laser,triamcinolone,or bevacizumab therapy or a combination of these treatments.
排除标准
- •uncontrolled blood pressure (systolic and diastolic blood pressure greater than 150 and 90 mm Hg, respectively)
- •renal insufficiency
- •intraocular surgery or any intravitreal treatment during the previous 3 months
- •history of ocular hypertension and/or glaucoma
研究组 & 干预措施
Plasmin
eyes with macular edema
干预措施: Intravitreal injection (Procedure)
结局指标
主要结局
Visual acuity after intravitreal autologous plasmin
时间窗: 1 Month after intervention
logMAR visual acuity
Central macular thickness after intravitreal autologous plasmin injection
时间窗: 1 month after intervention
Central macular thickness measured by optocal coherence tompgraphy
次要结局
- fibrinolytic system(baseline)
研究者
Jiwon Lim
MD PhD
Hallym University Medical Center