NCT05646004已完成不适用
An Open Single-arm Clinical Investigation to Evaluate the Clinical Safety and Effectiveness of 621
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Corrected Distance Visual Acuity (CDVA)
研究概览
简要总结
This study is evaluating the clinical safety and effectiveness of 621, after cataract 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Patient with clinically significant cataract with planned phacoemulsification cataract extraction and implantation of IOL into the capsular bag;
- •Preoperative corneal astigmatism ≤ 1.00D;
- •Patient is willing and capable of providing informed consent;
- •Patient is willing and capable of complying with visits and procedures as defined by this protocol.
排除标准
- •Preoperative best corrected visual acuity > 4.7 or ≤ 0.3 logMAR;
- •Corneal endothelial cell count less than 2000 cell/mm2;
- •Age under 18 years old;
- •Pregnant and lactating women;
- •Patients who attend other drug or medical device study;
- •Ocular disorder that could potentially cause a clinically significant future visual acuity loss;
- •Anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
- •Abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies);
- •Any condition in the study eye that could affect IOL stability (e.g. pseudo-exfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc;
- •Any acute infection (acute ocular disease, external/internal infection, systemic infection);
- •History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, microphthalmia, aniridia, epiretinal membrane etc.) in the study eye that could alter or limit final postoperative visual prognosis;
- •Any previous intraocular and corneal surgery ;
- •Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
- •Current systemic or ocular pharmacotherapy that effects patients' vision;
- •Current pathology or condition that could be a risk for the patient according to the investigator opinion;
- •Patients unable to meet the limitations of the protocol or likely of non-cooperation during the clinical investigation;
- •Patients whose freedom is impaired by administrative or legal order.
研究组 & 干预措施
621
Experimental
干预措施: Cataract surgery (Device)
结局指标
主要结局
Corrected Distance Visual Acuity (CDVA)
时间窗: 6 months
measurement of CDVA after IOL implantation
次要结局
未报告次要终点
研究者
研究点 (1)
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