NCT03247751已完成不适用
Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens
Nidek Co. LTD.0 个研究点目标入组 95 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 主要终点
- The intraocular lens rotation
研究概览
简要总结
To evaluate rotational stability of the investigational device implanted after cataract surgery.
详细描述
The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.
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
- •Adults, 18 years or older
- •Subject who diagnosed unilateral or bilateral age-related cataract.
- •Potential postoperative BCVA of 0.2 log MAR (0.63) or better.
- •Calculated IOL power in within the range of investigational IOL.
- •Subject is able to understand, agree and sign the informed consent statement.
- •Subject is able and willing to comply with the postoperative follow-up examination schedule.
排除标准
- •Uncontrolled systemic or ocular disease.
- •Extremely shallow anterior chamber.
- •Previous intraocular and corneal surgery.
- •Traumatic cataract.
- •Pregnancy or lactation.
- •Concurrent participation in another drug and device clinical investigation.
结局指标
主要结局
The intraocular lens rotation
时间窗: postoperative 6 months
The angle of the intraocular rotation.
次要结局
- visual acuity(postoperative 6 months)
- Adverse event(postoperative 6 months)
研究者
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