A Prospective, Randomized, Multi-Center, Open-Label Trial Comparing a Novel Goniotomy Procedure and an Ab Interno Trabecular Bypass Device in the Treatment of Mild to Moderate Glaucoma in Patients Undergoing Cataract Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Percent reduction in mean IOP
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of goniotomy performed with a novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate glaucoma subjects who are also undergoing cataract extraction with phacoemulsification (Phaco) and posterior chamber intraocular lens (PCIOL) implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of open angle glaucoma (including pseudoexfoliation and pigmentary glaucoma)
- •Diagnosis of mild to moderate glaucoma as defined by ICD-9 staging definitions 365.71 Mild/365.72 Moderate (including visual field defects and/or characteristic optic nerve abnormalities consistent with mild to moderate glaucoma)
- •Planned removal of a visually significant cataract as determined by the Investigator (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction
排除标准
- •Any glaucoma diagnosis other than those noted in inclusion criteria
研究组 & 干预措施
Goniotomy
Procedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant.
干预措施: Goniotomy (Procedure)
Goniotomy
Procedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant.
干预措施: Cataract Extraction (Procedure)
Trabecular Micro-Bypass Stent
Procedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant.
干预措施: Trabecular Micro-Bypass Stent (Device)
Trabecular Micro-Bypass Stent
Procedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant.
干预措施: Cataract Extraction (Procedure)
结局指标
主要结局
Percent reduction in mean IOP
时间窗: 12 months
次要结局
未报告次要终点