NCT00911924已完成4 期
A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 13
- 主要终点
- IOP 18 mm Hg or less with or without medications
研究概览
简要总结
Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.
详细描述
One hundred patients will be enrolled in the study at up to 21 sites; follow-up is through 1 year.
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
- •Diagnosis of primary open-angle glaucoma
- •Male or female at least 18 years of age and able to provide written informed consent
- •Mean IOP (at baseline visit after washout of any medications) must be at least 22 mm Hg and no greater than 38 mm Hg
- •Likely to be available and willing to attend follow-up visits
排除标准
- •Angle closure glaucoma
- •Secondary glaucomas
- •Prior glaucoma procedures
- •Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
研究组 & 干预措施
iStent
Experimental
干预措施: iStent (Device)
结局指标
主要结局
IOP 18 mm Hg or less with or without medications
时间窗: 12 months
IOP 18 mm Hg or less without medications
时间窗: At 6 months
次要结局
- Mean IOP(12 months)
研究者
研究点 (13)
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