An Observer-Masked, Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Surgical success rate of the MIMS® device/procedure at 12 months after surgery
研究概览
简要总结
The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy.
Eligible screened participants will undergo the MIMS® procedure and will be followed for a period of 12 months in this single-arm study. Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This clinical study is observer masked only when measuring intraocular pressure (using Goldmann Applanation Tonometry). Intraocular pressure measurements will be determined using the 2-person method to reduce bias. Observer 1 (masked to real time reading) will look through the slit lamp and turn the Goldmann Tonometer dial, and Observer 2 will read and record the intraocular pressure readings. Observer 1 will be unable to see the readings with the use of a masking card.
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
- •Male or female, ≥ 40 years to ≤ 85 years old
- •Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy
- •Primary open angle glaucoma diagnosis based on:
- •Visual field mean deviation of -3dB or worse and
- •Glaucomatous optic nerve damage as evidenced by optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos
- •Presence of healthy, free, and mobile conjunctiva in the target quadrant
- •Prior ab interno conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., iStent, Trabectome, gonioscopy-assisted transluminal trabeculectomy [GATT])
- •Subject is able and willing to attend all scheduled follow-up exams
- •Subject understands and signs the informed consent
排除标准
- 未提供
结局指标
主要结局
Surgical success rate of the MIMS® device/procedure at 12 months after surgery
时间窗: 12 months
Definition of Surgical Success: the subject's eye, after having the MIMS® procedure: 1. Achieved 20% or more reduction in average diurnal IOP from baseline at 12 months after surgery; AND 2. Using the same number or fewer topical IOP lowering medications
次要结局
- Exploratory Effectiveness Endpoint 2(12 months)
- Exploratory Effectiveness Endpoint 3(12 months)
- Safety Outcome 3(12 months)
- Exploratory Effectiveness Endpoint 1(12 months)
- Safety Outcome 2(12 months)
- Safety Outcome 1(12 months)
- Exploratory Effectiveness Endpoint 4(12 months)