NCT05090813已完成不适用
A Real-World Study Evaluating Clinical Outcomes in China for the TECNIS Eyhance™ Intraocular Lens Model ICB00
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA
研究概览
简要总结
This is a prospective and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Eyhance™ IOL. The study will enroll up to 100 subjects from a single site in China. All 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 patients at least 22 years of age
- •Have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with TECNIS Eyhance intraocular lens
- •Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits
- •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
- •Planned monovision correction (one eye designated for near correction).
- •Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).
结局指标
主要结局
percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA
时间窗: 6 months
mean monocular postoperative DCIVA
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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