Clareon TruPlus Single-Arm Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 5
- 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 research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs). IOLs are medical devices that are implanted in the eye during cataract surgery to restore clear vision after the cloudy natural lens has been removed. IOLs are intended to remain in the eyes for the duration of the patient's lifetime.
详细描述
In this study, subjects will be implanted with Clareon TruPlus Monofocal IOLs. The IOL to be implanted (Non-Toric or Toric) will be based on the recommendation of an IOL calculator.
Subjects will attend 8 study visits, including one preoperative visit, two surgical visits, and five postoperative visits. The second eye surgery will occur 0-14 days after the first eye surgery. The total duration of a subject's participation in the study will be approximately 13 months.
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
- •Diagnosed with bilateral cataracts and planned bilateral cataract extraction by routine phacoemulsification.
- •Potential postoperative BCDVA of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.
- •Astigmatism suitable for correction with available toric IOL models.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Age-related macular degeneration (AMD), glaucoma, diabetic retinopathy, and other eye conditions as specified in the protocol.
- •Moderate to severe dry eye that would affect study measurements.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Clareon TruPlus Monofocal IOL
Implantation with the Clareon TruPlus Monofocal IOL (Non-Toric or Toric) following removal of the clouded natural lens using phacoemulsification
干预措施: Clareon TruPlus Monofocal Non-Toric IOL (Device)
Clareon TruPlus Monofocal IOL
Implantation with the Clareon TruPlus Monofocal IOL (Non-Toric or Toric) following removal of the clouded natural lens using phacoemulsification
干预措施: Clareon TruPlus Monofocal Toric IOL (Device)
Clareon TruPlus Monofocal IOL
Implantation with the Clareon TruPlus Monofocal IOL (Non-Toric or Toric) following removal of the clouded natural lens using phacoemulsification
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: Day 0 preoperative, Month 1, Month 3, Month 12
Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place under photopic (well-lit) conditions at a distance of 4 meters. BCDVA will be measured using letter charts and recorded in logarithm of the Minimum Angle of Resolution (logMAR). The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. Subjects with at least one implanted eye with a toric IOL will be categorized as toric as specified in the statistical analysis plan. No hypothesis testing is pre-specified for this endpoint
次要结局
未报告次要终点