Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure: Long-Term Follow-Up Extension Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Intraocular Pressure Change (Baseline to 24 months)
研究概览
简要总结
A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment
排除标准
- 未提供
结局指标
主要结局
Intraocular Pressure Change (Baseline to 24 months)
时间窗: Baseline to 24 months post-MIMS® surgery
Change in IOP from medicated baseline to 24 months post-MIMS® surgery
Intraocular Pressure Change (Baseline to 30 months)
时间窗: Baseline to 30 months post-MIMS® surgery
Change in IOP from medicated baseline to 30 months post-MIMS® surgery
Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months)
时间窗: Medicated baseline to 24 months post-MIMS® surgery
Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery
Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months)
时间窗: Medicated baseline to 30 months post-MIMS® surgery
Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery
Surgery Success Rate (24 months)
时间窗: 24 months post-MIMS® surgery
Success rate 24 months post-MIMS® surgery
Surgery Success Rate (30 months)
时间窗: 30 months post-MIMS® surgery
Success rate 30 months post-MIMS® surgery
次要结局
- Postoperative Complication Safety Outcomes(Baseline to 30 months post-MIMS® surgery)
- Interventional Safety Outcomes(Baseline to 30 months post-MIMS® surgery)