NCT00612729已完成4 期
Influence of Light-filters in IOLs on Color Perception and Contrast Acuity. A Randomized, Double-masked Study With Intraindividual Comparison.
Hospital Hietzing2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年5月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- contrast acuity
研究概览
简要总结
Visible-light-filtering IOLs are implanted increasingly often in cataract surgery. Several studies examined the effect of light-filters on contrast and colour vision. However, the study outcomes were varying. The present study investigated the effect of two light-filtering IOL on colour perception and contrast acuity using highly sensitive measurement methods.
详细描述
Prospective, randomized, double-masked study with intraindividual comparison. Implantation of a Polylens Y30 IOL in one eye and an Orange Series Model PC 440 Y in the contralateral eye.
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, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bilateral age-related cataract
- •age 55 to 80 years
- •expected postoperative visual acuity of at least 1.0
排除标准
- •amblyopia
- •corneal scars
- •arterial hypertonia
- •pseudoexfoliation-syndrome
- •earlier ocular surgeries or laser treatments
- •intraocular tumors
- •color abnormalities
- •expected postoperative visual acuity lower 1.0
结局指标
主要结局
contrast acuity
时间窗: 3 month after surgery
次要结局
- visual acuity and color vision(3 month after surgery)
- colour perception(3 month after surgery)
研究者
研究点 (2)
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