Contralateral Claims Study of Clareon Vivity Pro
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 165
- 试验地点
- 16
- 主要终点
- Mean monocular photopic distance-corrected intermediate visual acuity (DCIVA)
研究概览
简要总结
The purpose of this study is to test new versions of Clareon Vivity Pro intraocular lenses (IOLs) by comparing them to currently marketed IOLs.
详细描述
Two sub-studies will be conducted. In Sub-Study B, Clareon Vivity Pro will be compared to Clareon Vivity. In Sub-Study C, Clareon Vivity Pro will be compared to TECNIS PureSee.
This study will be conducted in Australia.
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
- •Cataracts in both eyes.
- •Preoperative corneal astigmatism of less than 1.00 diopter (D) in each eye.
- •Potential postoperative best corrected visual acuity (BCDVA) of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Desires monovision correction.
- •Predicted post-operative residual astigmatism of more than 1D in either eye.
- •Any ocular or systemic co-morbidity that, in the investigator's medical opinion, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B)
Clareon Vivity Pro IOL implanted in one eye, with Clareon Vivity IOL in the fellow eye, as randomized
干预措施: Clareon Vivity Pro IOL (Device)
Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B)
Clareon Vivity Pro IOL implanted in one eye, with Clareon Vivity IOL in the fellow eye, as randomized
干预措施: Clareon Vivity IOL (Device)
Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C)
Clareon Vivity Pro IOL implanted in one eye, with TECNIS PureSee IOL in the fellow eye, as randomized
干预措施: Clareon Vivity Pro IOL (Device)
Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C)
Clareon Vivity Pro IOL implanted in one eye, with TECNIS PureSee IOL in the fellow eye, as randomized
干预措施: Cataract Surgery (Procedure)
Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C)
Clareon Vivity Pro IOL implanted in one eye, with TECNIS PureSee IOL in the fellow eye, as randomized
干预措施: TECNIS PureSee IOL (Device)
Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B)
Clareon Vivity Pro IOL implanted in one eye, with Clareon Vivity IOL in the fellow eye, as randomized
干预措施: Cataract Surgery (Procedure)
结局指标
主要结局
Mean monocular photopic distance-corrected intermediate visual acuity (DCIVA)
时间窗: Month 1 postoperative
Visual acuity (VA) will be assessed for each eye individually (monocular) with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA will be measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity.
次要结局
未报告次要终点