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
- 71
- 试验地点
- 12
- 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.
研究组 & 干预措施
CPO Pro IOL
CPO Pro IOL implanted in the first eye, as randomized. The fellow eye will receive CPO IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.
干预措施: CPO Pro IOL (Device)
CPO Pro IOL
CPO Pro IOL implanted in the first eye, as randomized. The fellow eye will receive CPO IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.
干预措施: Cataract Surgery (Procedure)
CPO Pro IOL
CPO Pro IOL implanted in the first eye, as randomized. The fellow eye will receive CPO IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.
干预措施: CPO IOL (Device)
CPO IOL
CPO IOL implanted in the first eye, as randomized. The fellow eye will receive CPO Pro IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.
干预措施: CPO Pro IOL (Device)
CPO IOL
CPO IOL implanted in the first eye, as randomized. The fellow eye will receive CPO Pro IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.
干预措施: CPO IOL (Device)
CPO IOL
CPO IOL implanted in the first eye, as randomized. The fellow eye will receive CPO Pro IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.
干预措施: Cataract Surgery (Procedure)
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.
次要结局
未报告次要终点