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临床试验/NCT00876707
NCT00876707已完成1 期

Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年3月最近更新:
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

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

申办方类型
Other

研究点 (2)

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