NCT04954898已完成不适用
Post-market Evaluation of Clinical Outcomes in China for the TECNIS® Multifocal Toric 1-Piece Intraocular Lens Model Series ZMT
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
- 102
- 试验地点
- 8
- 主要终点
- The percentage of eyes that are measured at the 1-day postoperative visit to demonstrate ≤10º change from The intended IOL axis at the end of surgery.
研究概览
简要总结
This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Multifocal Toric 1-Piece IOL. The study will enroll up to 120 subjects from up to 8 sites in China. The subjects will be followed for 12-months postoperatively.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 22 years of age
- •Have a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation
- •Regular corneal astigmatism that is planned for correction with an intraocular lens in the study eye(s)
- •Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with postoperative visits that are required by the study protocol
- •Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.
排除标准
- •Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
- •Ocular disease (other than cataract) that may significantly affect postoperative vision, such as visually significant keratopathy, macular lesions, diabetic retinopathy, chronic or severe uveitis, etc.
- •Planned monovision correction (one eye designated for near correction)
- •Severe or unstable systemic disease that may affect the heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, or psychoneurological dysfunction
- •Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study.
研究组 & 干预措施
Study Lens
Experimental
TECNIS Multifocal Toric 1-piece lens, Model ZMT
干预措施: Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT (Device)
结局指标
主要结局
The percentage of eyes that are measured at the 1-day postoperative visit to demonstrate ≤10º change from The intended IOL axis at the end of surgery.
时间窗: 1 day postoperative
The axis change is calculated as the absolute difference between intended IOL axis and the axis measured at follow-up visit(s).
次要结局
未报告次要终点
研究者
研究点 (8)
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