NCT03255785已完成不适用
A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One Trabecular Micro-bypass Stent and One Suprachoroidal Stent
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
- 15
- 试验地点
- 1
- 主要终点
- 20% IOP reduction from baseline
研究概览
简要总结
Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent
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
盲法说明
IOP outcome masked
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
- •Clinically significant cataract requiring surgery Primary open-angle or pseudoexfoliative glaucoma Visual field defects no worse than -12dB Subject on two ocular hypotensive medications at screening Medicated IOP at screening between 18 and 30 mm Hg Normal iridocorneal anatomy Absence of peripheral anterior synechiae
排除标准
- •Monocular subjects or those with wore than 20/200 vision in fellow eye Prior stent implantation, incision glaucoma surgery, or laser trabeculoplasty in study eye Traumatic, uveitic, or neovascular glaucoma
研究组 & 干预措施
G1 plus G3 with phaco
Experimental
Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra
干预措施: Cataract surgery plus one iStent and one iStent Supra implanted (Device)
结局指标
主要结局
20% IOP reduction from baseline
时间窗: Month 12
IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP
次要结局
- IOP less than or equal to 18 mm Hg(Month 12)
研究者
研究点 (1)
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