跳至主要内容
临床试验/NCT00721253
NCT00721253已完成4 期

Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL

Alcon Research1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2007年7月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
42
试验地点
1
主要终点
Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate

研究概览

简要总结

This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Diagnosed with cataracts

排除标准

  • •Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings

研究组 & 干预措施

ReSTOR Aspheric +4

Active Comparator

ACRYSOF ReSTOR Aspheric +4 Model SN6AD3

干预措施: ReSTOR (Device)

Tecnis MF

Active Comparator

Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900

干预措施: Tecnis (Device)

Acri.LISA

Active Comparator

Meditec Acri.LISA Intraocular Lens (IOL) Model 366D

干预措施: Acri.LISA (Device)

结局指标

主要结局

Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate

时间窗: 6 months

Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.

次要结局

  • Contrast Sensitivity(6 months)
  • Defocus Curve(6 months post-operative)

研究者

申办方类型
Industry

研究点 (1)

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