Observation on the Clinical Safety and Efficacy of UCP (Ultrasound Cyclo Plasty) in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- IOP(intraocular pressure)
研究概览
简要总结
Traditional ciliary body photocoagulation treatment uses the photocoagulation of long-wavelength laser to destroy the ciliary body tissue that can produce aqueous humor. Therefore, it is a kind of palliative treatment which has proved efficacy but causes great pain to patients. The "ultrasonic glaucoma treatment instrument" produced by French EYE TECH CARE company is referred to as EyeOP1. It uses high-intensity focused ultrasound technique to make target part of the ciliary coagulative necrosis, reduce the production of aqueous humor and thereby lower the intraocular pressure. EyeOP1 is ergonomic and suitable for the human eye, making the treatment process more accurate, simple and fast.
详细描述
- Efficacy: 1. Main objective: (1)Assess the decrease in postoperative intraocular pressure from baseline and evaluate the final results (the percentage of patients whose conditions have significant improved and the variation of the percentage of median intraocular pressure. (2)Assess the amount of medication after surgery.
- Secondary goals:(1) Compare median intraocular pressure with baseline at each postoperative follow-up and access the variation of median intraocular pressure from baseline at each postoperative follow-up. (2) Count the number of intraocular pressure lowering drugs at each postoperative follow-up.
b.Safety: Investigate the incidence of all device-related(or procedure-related) adverse events during the study (intraoperative and postoperative follow-up).
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
- 是
入选标准
- •The target eye was diagnosed as primary open-angle glaucoma; diagnostic criteria: IOP(intraocular pressure)≥ 21, open angle, typical glaucoma visual field and optic disc damage;
- •Patients treated with glaucoma medications cannot control intraocular pressure effectively;
- •Patients with 21mmHg ≤ IOP ≤ 30mmHg;
- •VA(visual acuity)≥HM(hand motions);
- •Patients that have failed conventional glaucoma surgery (trabeculectomy) or are not suitable for surgery;
- •Patients who have not received intraocular surgery or laser treatment 90 days before receiving HIFU;
- •Aged from 18 to 90 years old;
- •Sign informed consent and be willing to provide visit data;
排除标准
- •Either eye have any infections two weeks before the surgery;
- •The target eye has history of ciliary surgery, intraocular or retrobulbar tumor;
- •The target eye is neovascular glaucoma;
- •The target eye is aphakic eye;
- •Anterior anatomical abnormalities cause scleral expansion or ciliary body ectopic;
- •Non-glaucoma intraocular diseases that affect intraocular pressure;
- •Within 30 days, the patient participated in or was simultaneously included in other clinical trials;
- •Patients during pregnancy or lactation;
- •Any systemic disease that may affect patient follow-up.
结局指标
主要结局
IOP(intraocular pressure)
时间窗: 6 months after surgery
To evaluate the success rate of IOP control at 6 months after UCP(5mmHg≤IOP≤21mmHg, and at least 20% lower than the baseline)
次要结局
未报告次要终点