Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric IOLs
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
研究概览
简要总结
The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants who require cataract surgery in both eyes. The IOLs are designed to provide vision at far, arm's length, and near.
详细描述
Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. Both eyes will undergo cataract surgery. The second eye surgery will occur within 7 to 14 days of the first.
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
- •Subjects with cataracts in both eyes, planned for removal by routine surgery (phacoemulsification);
- •Subject must be able to understand and sign an approved informed consent form;
- •Subject is willing to complete all the required study visits for the duration of the study;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Ocular conditions as specified in the protocol;
- •Subjects who desire monovision correction;
- •Previous intraocular or corneal surgery;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Clareon PanOptix Pro/Pro Toric Trifocal IOL
The clouded lens will be removed by phacoemulsification, after which the PanOptix Pro and/or PanOptix Pro Toric IOLs will be implanted.
干预措施: Clareon PanOptix Pro/Pro Toric Trifocal IOL (Device)
Clareon PanOptix Pro/Pro Toric Trifocal IOL
The clouded lens will be removed by phacoemulsification, after which the PanOptix Pro and/or PanOptix Pro Toric IOLs will be implanted.
干预措施: Phacoemulsification (Procedure)
结局指标
主要结局
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
时间窗: Month 1 and Month 6 postoperative
Visual Acuity (VA) will be assessed for both eyes together (binocular) using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA will be measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision.
次要结局
未报告次要终点