Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 5
- 主要终点
- Variation between before and 2 months after surgery sleep time
研究概览
简要总结
The cataract surgery (550 000 operations per year in France) is to replace the cloudy lens with a refractive implant. Two colors of implants are available: white implants, filtering out ultraviolet and yellow implants, filtering and more blue light. No clinical data are available to assert the superiority of an implant according to its color and the choice is made according to the preference of the surgeon and / or "markets".
It is established in humans that blue light has an important role on the secretion of melanopsin, a key mediator of the circadian cycle. This "clock" regulates most neuroendocrine functions in the nycthémère (sleep, mood, temperature, cortisol, ..). The question of the impact of these neuro endocrine functions of the installation of a blue light filter into the eyes of patients operated thus arises.
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female or male subject
- •subject between 60 and 90 years old
- •Visual acuteness < or = with 2 eyes
- •Indication operating of the cataract
排除标准
- 未提供
结局指标
主要结局
Variation between before and 2 months after surgery sleep time
时间窗: 2 months
次要结局
- Variation between before and 2 months after surgery of the quality of sleep(2 months)
- Variation between before and 2 months after surgery the mood evaluation score(2 months)
- Variation between before and 2 months after surgery the number of hours of sleep(2 months)