A Prospective, Open, Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject 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
- 26
- 试验地点
- 3
- 主要终点
- Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation
研究概览
简要总结
The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (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
- Na
- 干预模型
- Single Group
- 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
结局指标
主要结局
Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation
时间窗: 6 months after implantation surgery
Change of Medicated diurnal IOP \[mmHg\] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication
次要结局
未报告次要终点