High Myopic Posterior Scleral Fixation System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Macular reduction rate
研究概览
简要总结
The purpose of this study is to assess the primary safety and efficacy of High Myopic Posterior Scleral Fixation System in the treatment of macular schisis caused by high myopia.
详细描述
Posterior Scleral Reinforcement（PSR） is the only surgical method that can delay the the development of high myopia. However, The surgical method is restricted by the material source limitation and macular ischemia in the eye after reinforcement. The investigators have designed a new posterior scleral fixation system，Its basic material is medical silicone，The product is designed to solve the problem of material source limitation and macular ischemia in the eye after reinforcement.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~65, male or female;
- •Refractive ranges from -6.00d to -25.00d;
- •The axial length of the operative eye was 26-32mm;
- •Macular cleavage 200-1000μm;
- •Corrected visual acuity of the operative eye < 0.3;
- •Able to understand the purpose of the test, voluntarily participate and sign the informed consent form.
排除标准
- •Known allergy to silica gel and patients with scar constitution;
- •Ocular inflammation;
- •Fundus hemorrhage;
- •Macular hole;
- •Macular cleavage of the contralateral eye greater than 200μm;
- •Corrected visual acuity of contralateral eye < 0.4;
- •Opacity of the refractive medium;
- •History of hyperthyroidism;
- •Other ophthalmic concomitant diseases that cannot be controlled, such as diabetic retinopathy, hypertensive fundus lesions, optic nerve atrophy, etc.;
- •Severe impairment of liver and kidney function and/or severe systemic diseases (such as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary, etc., depending on the tolerance of surgery);
- •Women who are pregnant (determined by a blood pregnancy test at the first visit), who are preparing for pregnancy during the test, and who are breastfeeding;
- •a history of drug abuse or alcohol abuse;
- •participate in other drug or medical device clinical trials within 30 days prior to the screening of this clinical trial;
- •Any condition of the subject that the study physician considers to be an impediment to the clinical trial (e.g. subject's susceptibility to mental stress, uncontrollable mood, depression, etc.);
- •Poor compliance of the subject, unable to complete the test process as required.
结局指标
主要结局
Macular reduction rate
时间窗: 24 weeks
24 weeks after implantation of the High Myopic Posterior Scleral Fixation System
次要结局
- Axial length(Baseline (Before surgery), 24 weeks after surgery)
- Diopter(Baseline (Before surgery), 24 weeks after surgery)
- Best corrected visual acuity(Baseline (Before surgery), 1 day, 1 week, 4 weeks, 12 weeks, 24 weeks,)