NCT01444105已完成不适用
A Prospective, Randomized, Controlled, Parallel Groups Evaluation of Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty
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
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit.
研究概览
简要总结
Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.
详细描述
Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phakic study eye or study eye with a posterior chamber intraocular lens (PC-IOL)
- •Primary open-angle glaucoma (including pseudoexfoliative)
排除标准
- •Aphakic or pseudophakic with anterior chamber IOLs (AC-IOLs) (study eye)
- •Prior stent implantations (study eye)
研究组 & 干预措施
iStent
Active Comparator
implantation of two iStent devices
干预措施: iStent (Device)
SLT
Active Comparator
Laser treatment
干预措施: SLT (Other)
结局指标
主要结局
Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit.
时间窗: 12 Months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or TravoprostOpen-angle GlaucomaNCT01444040Glaukos Corporation196
已完成
4 期
Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or TravoprostOpen-angle GlaucomaNCT01443988Glaukos Corporation101
已完成
不适用
Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract SurgeryOpen-angle GlaucomaNCT01455467Glaukos Corporation79
招募中
4 期
Travoprost Intraocular Implant + iStent InfiniteGlaucoma, Open-AngleNCT06066645Glaukos Corporation150
已完成
4 期
Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive AgentsOpen-angle GlaucomaNCT02873806Glaukos Corporation53