A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 主要终点
- Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12
研究概览
简要总结
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted.
详细描述
This is a prospective, multicenter, single-masked, randomized clinical trial comparing Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract. Eligible patients will be scheduled for cataract surgery. At the conclusion of successful cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative follow-up visits will be conducted at regular intervals.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG)
- •An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.
排除标准
- •Forms of primary or secondary glaucoma not listed above
- •Prior glaucoma surgery in the study eye
研究组 & 干预措施
Hydrus Microstent
Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)
干预措施: Hydrus Microstent (Device)
Hydrus Microstent
Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)
干预措施: Cataract removal and intraocular lens (IOL) implantation (Procedure)
iStent
Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
干预措施: iStent Trabecular Micro Bypass (Device)
iStent
Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
干预措施: Cataract removal and intraocular lens (IOL) implantation (Procedure)
结局指标
主要结局
Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12
时间窗: Month 12: 8 am, 12 pm, 4 pm
Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.
次要结局
- Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12(Month 12: 8 am, 12 pm, and 4 pm)
- Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12(Month 12: 8 am, 12 pm, 4 pm)