Clinical and Functional Performance of Acrysof IQ Vivity Versus Aspheric Monofocal IOLs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Binocular photopic best-corrected distance visual acuity (BCDVA)
研究概览
简要总结
The purpose of the study is to evaluate clinical and functional performance in real-world conditions in participants who have been implanted with Acrysof IQ Vivity (Extended Vision) IOLs compared with Alcon Aspheric Monofocal IOLs.
详细描述
This observational study will enroll subjects who have been implanted with an Alcon aspheric monofocal or monofocal toric IOL no less than 4 months prior to study procedures. This study will be conducted in Australia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good general health at the screening visit;
- •Implanted in both eyes at least 4 months ago with either Vivity/Vivity toric IOL or an Alcon aspheric monofocal/monofocal toric IOL (Acrysof IQ/Clareon);
- •Best Corrected Distance Visual Acuity (BCDVA) of 20/25 or better with both eyes together;
- •BCDVA of 20/40 or better in each eye;
排除标准
- •Clinically significant Posterior Capsular Opacity (PCO) as assessed via slit-lamp exam per investigator opinion;
- •History of ocular surgery other than cataract surgery and Nd:YAG laser surgery;
- •History of amblyopia.
结局指标
主要结局
Binocular photopic best-corrected distance visual acuity (BCDVA)
时间窗: At least 4 months post-operative
Visual acuity will be measured using a standard visual acuity chart at a distance of 4 meters under photopic (well-lit) conditions and reported in logarithm Minimum Angle of Resolution (logMAR) units. Visual acuity will be measured binocularly (both eyes together).
次要结局
未报告次要终点