XEN45 in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- IOP (intraocular pressure) changes
研究概览
简要总结
Glaucoma is the second most common blindness disease in the world, second only to cataracts. The current treatment of glaucoma is mainly to reduce intraocular pressure.At present, two commonly used surgical methods are trabeculectomy and implantation of drainage valve. These methods are superior to drug treatment in reducing intraocular pressure, but the effect duration of these two methods is not long, and there may be serious complications and failure.
Compared with traditional glaucoma surgery, MIGS may have better safety.The XEN45 gel implant is a collagen tube with a length of 6 mm and a diameter of 45 µm, which creates a new channel for drainage of aqueous humor by connecting the anterior chamber and the subconjunctival space. The implant is composed of porcine gelatin cross-linked with glutaraldehyde, and has good biocompatibility and tolerance. Therefore, after the advent of XEN45 products, more and more studies have shown that this treatment has excellent safety and effectiveness in reducing intraocular pressure in patients with open-angle glaucoma.
Considering that the XEN45 gel stent has been in the market for a relatively short time, we conducted this prospective study to investigate the effect of XEN45 surgery in the treatment of primary open-angle glaucoma, in order to support ophthalmologists in formulating the best surgical plan for patients. The promotion of this surgical method.
详细描述
Observation index： The visual acuity, intraocular pressure, slit lamp, ophthalmoscope, traditional vision, UBM and anti-glaucoma drugs before surgery and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with POAG;
- •The visual acuity of the affected eye is greater than that of manual operation;
- •Between 18 and 90 years old;
- •No surgery or laser treatment within 90 days;
- •Patients with other types of glaucoma whose intraocular pressure has not been controlled by traditional surgery or medication;
- •The target quadrant has healthy conjunctiva and free movement without scars.
排除标准
- •Angle-closure glaucoma;
- •Active uveitis;
- •Any corneal disease;
- •Patients with eye infections two weeks before the operation;
- •During pregnancy or lactation;
- •Active neovascular glaucoma;
- •Known or suspected allergy or sensitivity to pig products or glutaraldehyde.
结局指标
主要结局
IOP (intraocular pressure) changes
时间窗: 3 months after surgery
Compare the patient's IOP changes before and after surgery. Complete success of the operation was defined as IOP≤21mmhg without any glaucoma drugs. Qualified success is defined as the same intraocular pressure level but with medication. Failure is defined as IOP\> 21 mmHg and maximum tolerance of the drug
次要结局
- BCVA（Best corrected vision ability）changes(Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery)
- anti-glaucoma drugs changes(Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery)
- IOP (intraocular pressure) changes(Baseline (before surgery) and 1 day, 1 week, 1 month,6 month and 12 months after surgery)