NCT00876707已完成1 期
Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- visual acuity, wavefront data and modulation transfer function
研究概览
简要总结
The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D
排除标准
- •Any ocular diseases, such as:
- •corneal opacities or irregularity
- •amblyopia
- •anisometropia
- •retinal abnormality
- •Surgical complications
- •IOL decentration greater than 0.4 mm (estimated by retroillumination)
- •Incomplete follow-up
结局指标
主要结局
visual acuity, wavefront data and modulation transfer function
时间窗: 30, 90 and 120 days after surgery
次要结局
- contrast sensitivity(90 days after surgery)
研究者
研究点 (2)
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