A Prospective, Open, Multicentre Clinical Trial Analysing the Effectiveness and Safety of MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Reduction in medicated diurnal IOP
研究概览
简要总结
The study will evaluate the efficacy and safety of MINIject 636 and IOP lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.
The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
- •Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
- •Glaucoma not adequately controlled
排除标准
- •Diagnosis of glaucoma other than open angle glaucoma
- •Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
- •Neovascular glaucoma in the study eye
- •Prior glaucoma surgery in the study eye
- •Clinically significant corneal disease
- •Patients with poor vision
研究组 & 干预措施
MINIject DO Integrated System CS636 (MINI DO636)
MINIject 636 implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive glaucoma surgical intervention.
The intervention is to be performed as stand-alone surgery. In this arm the implant is placed using Dual Operator Delivery Tool (DODT).
干预措施: MINI DO636 (Device)
MINIject SO Integrated System CS636 (MINI SO636)
MINIject 636 implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive glaucoma surgical intervention.
The intervention is to be performed as stand-alone surgery. In this arm the implant is placed using Single Operator Delivery Tool (SODT).
干预措施: MINI SO636 (Device)
结局指标
主要结局
Reduction in medicated diurnal IOP
时间窗: 6 months after surgery
DODT/SODT arm will be evaluated separately
次要结局
未报告次要终点