Effect of Blue Light Filtration on Visual Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 主要终点
- Photostress Recovery Time
研究概览
简要总结
The purpose of this study is to evaluate photostress recovery with blue light filter clip-on glasses among pseudophakes [ie, subjects in which the natural lens of the eye has been replaced with an artificial lens (intraocular lens) during cataract surgery]. This study will enroll subjects previously implanted with no blue light filter intraocular lenses (IOLs) for at least 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract surgery in both eyes with no blue light filtering intraocular lenses for at least 3 months;
- •Good ocular health;
- •20/40 or better vision with best correction in both eyes;
- •Willing to provide voluntary consent and sign informed consent form;
- •Able to competently perform testing;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Ocular pathology, degeneration, or media opacity (cloudiness) that could impact study measurements;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Clear, then Blue Light Filter
Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
干预措施: Clear clip-on glasses (Device)
Clear, then Blue Light Filter
Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
干预措施: Blue light filter clip-on glasses (Device)
Blue Light Filter, then Clear
Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
干预措施: Clear clip-on glasses (Device)
Blue Light Filter, then Clear
Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
干预措施: Blue light filter clip-on glasses (Device)
结局指标
主要结局
Photostress Recovery Time
时间窗: Day 1
Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed.
次要结局
未报告次要终点