NCT05089474已完成不适用
A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12.
研究概览
简要总结
A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery.
详细描述
A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, a viscoelastic delivery device, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. This is a 12 month study conducted outside the US. Approximately 60 subjects will be enrolled.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and execute written informed consent
- •Males or female subjects at least 22 years of age.
- •Subjects qualifying for cataract surgery
- •Subjects diagnosed with mild to moderate open-angle glaucoma in at least one eye currently treated with 1-3 topical IOP-lowering medications
- •Subjects with diagnosis of open-angle glaucoma in at least one eye with an unmedicated IOP of 21-36 mmHg
排除标准
- •Women of child-bearing potential
- •Modified Shaffer angle grade < 2
- •Patients with severe or advanced glaucoma
- •Intraocular surgery within the last 6 months or laser surgery within the last 3 months
- •BCVA worse than 20/80 in either eye
- •Patients with a previous peripheral iridotomy.
- •Ocular infection or inflammation within the last 6 months.
- •Any medication that would be contraindicated for a glaucoma surgical procedure.
研究组 & 干预措施
Streamline
Experimental
Streamline Surgical System
干预措施: Streamline Surgical System (Device)
结局指标
主要结局
proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12.
时间窗: 12 months
Primary Endpoint
次要结局
- Mean IOP change(12 months)
- Adverse Events(12 months)
- Number of topical glaucoma medications(12 months)
研究者
研究点 (3)
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