Silicone Tube Miniature Drainage Device Implanted Under Scleral Flap for the Surgical Treatment of Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 主要终点
- IOP
研究概览
简要总结
The biocompatible silicone tube miniature drainage device is a small, non-valved implant to shunt aqueous humor underneath the conjunctiva to control the intraocular pressure. Efficacy and safety were evaluated with a minimum follow-up of 12 months.
详细描述
Patients were examined postoperatively at 1 day, 1 week, 1, 3, 6, 12, 18, 24 months or more frequent when required. IOP, BCVA and slit lamp biomicroscopy were observed at every visit. History of all medication details and postoperative complications were recorded. One-way analysis of variance (ANOVA) with repeated measures was used to analyze the other differences over time in IOP and BCVA. Nonparametric K-related samples test was used to analyze the difference of medications number at different time points. Success rates were evaluated using Kaplan-Meyer survival analysis curves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Eligible patients were at least 18 years of age and presented with medically uncontrolled POAG requiring incisional surgery for IOP (intraocular pressure) reduction.
排除标准
- •Exclusion criteria included narrow angles, normal tension glaucoma, previous eye surgery (except cataract surgery), neovascular glaucoma, uveitis, any ocular abnormality that would preclude accurate IOP assessment, and inability to comply with the follow-up program or unwillingness to participate in this study.
结局指标
主要结局
IOP
时间窗: 3 years
Intraocular pressure
次要结局
- Number of anti-glaucoma medication(3 years)
研究者
yin ying zhao
Zhejiang Eye Hospital
Wenzhou Medical University