NCT01592955已完成4 期
Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound With the EyeOP1 Medical Device.
EyeTechCare14 个研究点 分布在 4 个国家目标入组 84 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 14
- 主要终点
- Efficacy endpoint : Success / failure rate at 1 year
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device 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
- •Refractory Glaucoma
- •IOP > 21 mm Hg
- •No previous intraocular surgery or laser treatment during the 90 days before HIFU day
- •Age > 18 years
- •Informed consent sgned by the subject
排除标准
- •Normal Tension Glaucoma
- •Glaucoma drainage device implanted and still present in the eye to be treated
- •History of ocular or retrobulbar tumor
- •Ocular infection within 14 days prior to the HIFU procedure
- •Aphakic patient
- •Ocular disease other than glaucoma that may affect assessment of visual and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema)
- •Pregnant or breast-feeding women, or lack of contraception use among women likely to have a child
结局指标
主要结局
Efficacy endpoint : Success / failure rate at 1 year
时间窗: 12 months
IOP change (mm Hg and percent) from baseline to 12 months post-HIFU treatment. (Success defined by IOP reduction \> 20% compared to the baseline IOP or IOP \< 21 mmHg)
次要结局
- Safety measures(12 months)
研究者
研究点 (14)
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