Efficacy and Safety of Trabecular Meshwork Microstent Drainage System in Reducing Intraocular Pressure in Adult Patients with Mild to Moderate Open-angle Glaucoma Combined with Cataract: a Prospective, Multicenter, Randomized, Open Label, Parallel Controlled, Superiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Percentage of subjects with reduction of IOP greater than or equal to 20% compared to baseline in 12th month after surgery
研究概览
简要总结
It is a prospective, multicenter, randomized, open label, parallel controlled, superiority clinical trial that evaluate efficacy and safety of Trabecular Meshwork Microstent Drainage System in Reducing Intraocular Pressure in Adult Patients With Mild to Moderate Open-angle Glaucoma Combined With Cataract.
详细描述
The trial is a prospective, multicenter, randomized, open label, parallel controlled, superiority study. Eligible subjects will be randomly assigned to either test group or control group for treatment. The trial is divided into four research stages, with each subject expected to participate for maximum 14 months. The entire research phase includes:
Screening visit (V1, -60~-1 day). Baseline visit (V2). Randomization and surgery (V3): The subjects will be randomly assigned in 2:1 ratio to either test group (phacoemulsification with implantation of IOL combined with implantation of trabecular meshwork microstent drainage system) or control group (phacoemulsification with implantation of IOL only).
Follow-up visits (V4 ~ V10): different time points after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male of female, age 18 years or older
- •Mild to moderate open-angle glaucoma
- •Average of IOP is less than or equal to 24mmHg with 1-3 drugs in the screening period
- •All 3 diurnal IOPs after drug-eluting are greater than 21mmHg and less than or equal to 35mmHg, average of diurnal IOPs is at least 3.0mmHg higher than the pre drug-eluting IOP
- •Cup to disc ratio (C/D) less than or equal to 0.8, or VFI greater than 75%
- •Gonioscope shows that anterior chamber angle is open
排除标准
- •Traumatic, uveitic, neovascular, angle-closure glaucoma or glaucoma associated with vascular disorders
- •Active corneal inflammation or edema
- •Retinal disorders not associated with glaucoma
结局指标
主要结局
Percentage of subjects with reduction of IOP greater than or equal to 20% compared to baseline in 12th month after surgery
时间窗: 12 months
IOP measured by Goldmann applanation tonometry
次要结局
未报告次要终点