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临床试验/NCT00759096
NCT00759096已完成不适用

Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

Alcon Research2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年5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
30
试验地点
2
主要终点
Near Uncorrected Visual Acuity(UCVA

研究概览

简要总结

The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • ≥21 years of either gender or any race
  • Potential post-op VA 20/20
  • Pre-op astigmatism ≤ 1.0D
  • Able to sign the informed consent
  • Able to complete all required postoperative visits
  • Planned cataract removal by phaco
  • Clear intraocular media other than cataract

排除标准

  • Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture
  • Any corneal pathology and previous corneal refractive surgery
  • Patients with unrealistic expectations in anticipated post-op VA
  • Happy to wear glasses
  • Occupational night driver

结局指标

主要结局

Near Uncorrected Visual Acuity(UCVA

时间窗: 6 months after surgery of 2nd eye

Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.

次要结局

  • Contrast Sensitivity(6 months after sugery of the 2nd eye)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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