NCT01338467已完成不适用
Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma
EyeTechCare16 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2011年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 16
- 主要终点
- Primary efficacy measure :
研究概览
简要总结
The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary open angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma in the study eye with maximally tolerated medical treatment
- •Ocular hypertension defined as an intraocular pressure (IOP) > 21 mm Hg
- •Subject has failed a conventional intraocular glaucoma filtering surgery
- •Patient must be aged 18 years or more
- •No previous intraocular glaucoma surgery or laser treatment in the study eye during the 3 months before HIFU treatment
- •No previous cyclophotocoagulation procedure in the study eye
- •Patient able and willing to provide informed consent and to complete post-operative follow-up requirements.
排除标准
- •History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye
- •History of ocular or retrobulbar tumor
- •Retinal detachment, choroidal hemorrhage or detachment
- •Ocular infectious disease within 14 days before HIFU treatment
研究组 & 干预措施
EYEOP Treatment
Experimental
Open label, all subject treated by the EYEOP device
干预措施: EYEOP device (Device)
结局指标
主要结局
Primary efficacy measure :
时间窗: 6 months
IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment
次要结局
- Safety measures(6 months)
研究者
研究点 (16)
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