Minimally Invasive Micro Sclerostomy System - Long- Term Follow-Up Extension Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Observed IOP at Long- Term ( >2 Years) post-MIMS® surgery:
研究概览
简要总结
No new investigational device is used in this study. This study is an extension follow up study conducted in continuation of the prior MIMS® study (see: STUDY ID: MMS EEU-1), in which the long-term (i.e., 28, 36, 42 months) clinical outcomes of Minimally Invasive Micro Sclerostomy System [MIMS® System] [CE Marked device] are evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years to ≤ 85 years old
- •Subject who underwent either standalone MIMS® surgery or MIMS® surgery in combination with phacoemulsification, in continuation of the previous clinical investigation with the MIMS® device (see: STUDY ID: MMS EEU-1), and surgery was performed not earlier than 2 years from enrollment
- •Subject who is considered complete success (i.e., 20% or greater reduction in IOP from Baseline on no medications) and qualified success (i.e., 20% or greater reduction in IOP from Baseline on the same or less number of medications) or failure with IOP >21mmHg with no medications at 1 year post MIMS® surgery (see: STUDY ID: MMS EEU-1)
- •Subject who is able and willing to attend all scheduled assessments
- •Subject understands and signs the informed consent
排除标准
- •Subject who was considered failure at 1 year after the MIMS® surgery
- •Any subject with major protocol deviation from the prior MIMS® study (ID: MMS EEU-1)
- •Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye, since the MIMS® surgery in the study eye
- •Any ocular disease in the study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements
- •Any ocular surgery since the MIMS® surgery in the study eye
- •Severe trauma in the study eye since the MIMS® surgery in the study eye
- •Current participation or participation in another investigational drug or device clinical trial within the last 30 days before enrollment in the study
- •Pregnant or lactating women
研究组 & 干预措施
Intervention Arm: MIMS® Minimally Invasive Trabeculostomy in OAG Patients (36-Month Follow-Up)
This follow-up extension study is aimed to monitor the long-term IOP-lowering performance/efficacy and safety of the MIMS® procedure in open angle glaucoma eyes.
干预措施: MIMS (Diagnostic Test)
结局指标
主要结局
Observed IOP at Long- Term ( >2 Years) post-MIMS® surgery:
时间窗: 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery
• IOP will be measured for subjects who have completed the MIMS® surgery and no earlier than 2 years from the procedure.
次要结局
- • IOP Levels at the following time points:(28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery)