Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 16
- 主要终点
- Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.
详细描述
Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 6 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Understand and sign an ethics committee-approved informed consent form;
- •Willing and able to attend all scheduled study visits as required by the protocol;
- •Planned cataract surgery (both eyes);
- •Preoperative corneal astigmatism less that 1.00 diopter in each eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding;
- •Ocular conditions as specified in the protocol;
- •Subjects who desire monovision correction.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
时间窗: Month 2 postoperative
Visual Acuity (VA) was assessed for each eye individually 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 was 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.
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
时间窗: Month 2 postoperative
Visual Acuity (VA) was assessed for each eye individually 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 was 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