Comparative Clinical Trial on the Efficacy and Safety of Non-resorbable Uveoscleral Implant Associated With Absorbable Collagen Matrix vs Isolated Absorbable Collagen Matrix in Non-perforating Deep Sclerectomy in Glaucoma Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Number of Intraocular pressure
研究概览
简要总结
The aim of the study is to evaluate and compare the hypotensive efficacy at 24 months between non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.
详细描述
The aim of this study is to evaluate and compare the hypotensive efficacy at 24 months between two implants in glaucoma surgery. Non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Evaluations will be done an outcome assessor that do not know the intervention group
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
- •Patients older than 18 years of age
- •Primary or secondary open-angle glaucoma
- •High intraocular pressure (greater than or equal to 18mmHg) despite using maximum medical treatment
- •Intolerance to medication.
排除标准
- •Patients with previous glaucoma surgery
- •Previous ocular surgery in the last 6 months
- •Previous history of Laser trabeculoplasty in the last 12 months
- •Moderate or severe diabetic retinopathy
- •Active or recurrent eye disease (uveitis)
- •Plateau iris
- •Ocular neovascularization
- •Neovascular angle-closure glaucoma
- •Previous history of intraocular or extraocular malignant neoplasm
- •Pregnancy or lactation period, axial length> 26mm and <20mm
- •Unwillingness for participating
结局指标
主要结局
Number of Intraocular pressure
时间窗: 24 hours after surgery, 3 months, 12 months, 24 months
Comparison of intraocular pressure measurements
次要结局
- Number of adverse events(24 hours after surgery, 3 months, 12 months, 24 months)