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临床试验/NCT01027533
NCT01027533已完成不适用

Visual Performance of New Apodized Diffractive Multifocal IOL With Addition of Plus Three

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
distance,intermediate and near visual acuity

研究概览

简要总结

The purpose of the study is to determine whether implantation of a multifocal IOL with a modified addition at lens plane(Restor +3) results in better intermediate visual acuity with similar performance at distance and near compared to other multifocal IOL with similar design but with higher addition at lens plane. Patient's contrast sensitivity of vision and best reading distance following Restor +3 implantation were also assessed.

Study hypothesis: the implantation of an intraocular lens (IOL) with a modified addition at lens plane (restor +3, Alcon Laboratories,Inc) results in better intermediate visual acuity with similar distance and near visual acuity after cataract surgery.

详细描述

Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.

Patients will be examined before surgery and at 1, 7, 30, 90 days and 3and 6 months after surgery.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • ••Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters)

排除标准

  • •Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities
  • •Surgical complications
  • •Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)
  • •Incomplete follow-up.

结局指标

主要结局

distance,intermediate and near visual acuity

时间窗: 1, 3 and 6 months

次要结局

  • reading speed and contrast sensitivity(6 months)

研究者

申办方类型
Other

研究点 (1)

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