A Prospective, Open, Multicenter Clinical Trial Evaluating the Efficacy and Safety of MINIject Combined With Cataract Surgery in Patients With POAG Uncontrolled by Topical Hypotensive Medications and Operable Age-related Cataract Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP
研究概览
简要总结
The study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.
详细描述
The study aims to evaluate the safety and efficacy of the MINIject in the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) in conjunction with cataract surgery. The cataract surgery will be performed first and if successful, only then will the MINIject be placed.
Patients will be followed for 2 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.
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
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary open angle glaucoma (POAG) in the study eye
- •Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
- •Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the patient has an allergy / intolerance to a medication
- •Patient must provide written informed consent to participate
排除标准
- •Known or suspected allergy or hypersensitivity to medical silicone
- •Allergy to fluorescein
- •Presence of silicone oil in the study eye
- •Individuals under tutorship or trusteeship
- •Patient has a condition such that his / her ability to provide personal informed consent is compromised
结局指标
主要结局
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP
时间窗: 6 months
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, with or without IOP lowering medications
次要结局
未报告次要终点