NCT01791673已完成不适用
Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.
EyeTechCare5 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20%
研究概览
简要总结
The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients
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
- 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
- •IOP > 21 mm Hg on glaucoma medications, and indicated for filtering glaucoma surgery
- •Patient must be aged 18 years and more
- •No previous cyclophotocoagulation procedure in the eye
- •No previous laser treatment in the eye during the 3 months before HIFU procedure
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 diseasee within 14 days before HIFU procedure
结局指标
主要结局
Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20%
时间窗: up to 12 months
Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)
次要结局
- Average change in IOP (mm Hg)(3, 6 and 12 months)
- Percentage change in IOP from baseline(3, 6 and 12 months)
- Average change in glaucoma hypotensive medications(3, 6 and 12 months)
- Incidence of device and procedure-related complications during follow-up(3, 6 and 12 months)
研究者
研究点 (5)
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