NCT04145830已完成不适用
Efficacy and Safety of UCP in the Treatment of Primary Glaucoma in China
EyeTechCare2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年9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
- 2
- 主要终点
- Efficacy endpoint : reduction of the intraocular pressure
研究概览
简要总结
To collect safety and efficacy data on Ultrasound Cycle Plasty treatment (UCP) in primary glaucoma asian 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Open Angle and primary Angle Closure glaucoma
- •Subject where the IOP is not adequately controlled with glaucoma medication, and can not or not agree for incisional glaucoma surgery
- •IOP ≥ 21 mmHg and ≤ 40 mmHg
- •Best Corrected Visual Acuity > Hand Motion
- •Patient able and willing to sign the informed consent and complete postoperative followup requirements
排除标准
- •History of ocular or retrobulbar tumor
- •Ocular infection within 14 days prior to the procedure of Ultrasound Cyclo Plasty (UCP)
- •History of Cyclo-destructive procedures (cryotherapy, Laser transscleral cyclophotocoagulation; Laser endophotocoagulation)
- •Congenital glaucoma
- •History of ciliary body surgery or vitrectomy in the study eye
- •Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema, retinal detachment)
结局指标
主要结局
Efficacy endpoint : reduction of the intraocular pressure
时间窗: 6 months
Reduction of the intraocular pressure relative to the preoperative value at each follow-up visits in mmHg and in % of reduction
次要结局
- Safety endpoint: rate of per operative complications(6 months)
- Safety endpoint: rate of post-operative complications(6 months)
- Efficacy endpoint: Number of ocular hypotensive medications(6 months)
研究者
研究点 (2)
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