Functional Benefit With ACRYSOF® Natural Chromophore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Change in Braking Reaction Time From No-glare to Glare
研究概览
简要总结
The purpose of this study is to compare the reaction time (as measured by braking reaction time in seconds during simulated driving) under glare and no-glare conditions in subjects implanted with ACRYSOF® IQ intraocular lenses (IOLs) to subjects implanted with clear IOLs. This study will enroll subjects previously implanted with IOLs in both eyes for at least 3 months.
详细描述
Subjects completed 2 visits to the investigational site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pseudophakes with ACRYSOF® IQ monofocal IOLs or clear (no blue light filter) IOLs in both eyes for at least 3 months.
- •Willing and able to understand and sign an informed consent form.
- •Corrected visual acuity (CVA) of 20/40 or better.
- •Have a valid driver's license.
- •Depth perception of at least 100 arc seconds.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Ocular pathology, degeneration, or media opacity.
- •Color vision defect.
- •Use of ocular or systemic medications that impact macular pigment density or reaction time, including but not limited to, lutein, zeaxanthin, barbiturates, tranquilizers or amphetamines.
- •System conditions affecting connective tissue or sensory-motor coordination.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Change in Braking Reaction Time From No-glare to Glare
时间窗: Visit 2, up to Day 30
Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.
次要结局
- Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)(Visit 2, Up to Day 30)
- Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)(Visit 2, Up to Day 30)