A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Unmedicated IOP </= 19 mmHg at 12 Months
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.
详细描述
This is a prospective, multicenter, single-masked, randomized clinical trial comparing the Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma. 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
- 45 Years 至 84 Years（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 glaucoma (PG)
- •A phakic lens with BCVA of 20/30 or better
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
Patients randomized to the Hydrus Microstent .
干预措施: Hydrus Microstent (Device)
iStent Trabecular Micro Bypass
Patients randomized to the iStent Trabecular Micro Bypass
干预措施: iStent Trabecular Micro Bypass (Device)
结局指标
主要结局
Unmedicated IOP </= 19 mmHg at 12 Months
时间窗: 12 months
Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 12 months
次要结局
- Unmedicated IOP </= 19 mmHg at 24 Months(24 Months)
- Unmedicated IOP </= 18 mmHg at 12 Months(12 months)
- The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months(12 & 24 Months)
- Mean Medication Use at 12 and 24 Months(12 & 24 Months)