NCT03145103已完成不适用
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study
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
- 282
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
- •Patients of any gender
- •Assured follow-up examinations
- •Biometry measurement preferably compatible with the IOLMaster evaluation;
- •IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
- •Patients who had uncomplicated (no peroperative complication) aged-related cataract surgery in a healthy eye (beside clinically significant cataract)
排除标准
- •BCVA not available preoperatively or better than 0.3 logMAR pre-op
- •Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
- •Patients whose freedom is impaired by administrative or legal order
- •Concurrent participation in another drug or device investigation -
研究组 & 干预措施
409M
Experimental
CT ASPHINA 409M IOL
干预措施: CT ASPHINA 409 (Device)
结局指标
主要结局
Visual acuity
时间窗: 12 to 18 months after surgery
Monocular best corrected distance visual acuity
次要结局
未报告次要终点
研究者
研究点 (2)
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