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临床试验/NCT04913792
NCT04913792Unknown不适用

Clinical Outcomes With an Extended Range of Vision Intraocular Lens

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Uncorrected distance VA(5m,66cm,40cm)

研究概览

简要总结

To evaluate the clinical outcomes with an extended range of vision (ERV) IOL based on achromatic diffractive technology.

详细描述

This was a prospective comparative study including 60 eyes undergoing cataract surgery with implantation of the ERV Tecnis Symfony IOL (Abbott Medical Optics, Inc.) (ERV group: 60 eyes of 30 patients). Visual, refractive, contrast sensitivity, defocus curve, ocular optical quality (Optical Quality Analysis System; iTrace), and visual function questionair(NEI-VFQ 25) outcomes were evaluated during a 3-month follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • visually significant cataract
  • age of 20 years or older
  • preoperative corneal astigmatism of 1.50 diopters (D) or lower.

排除标准

  • previous ocular surgery
  • active ocular pathology
  • amblyopia
  • systemic or ocular medication that could affect vision
  • subclinical or clinical corneal ectatic disease
  • pupil abnormalities
  • intraoperative complication leading to capsular or zonular abnormalities

结局指标

主要结局

Uncorrected distance VA(5m,66cm,40cm)

时间窗: After operation (Month 3)

logarithmic visual acuity chart

次要结局

  • Questionnaire concerning halo and visual function(After operation (Month 3))
  • abberation and kappa angle(After operation (Month 3))
  • MTF cut-of and OSI(After operation (Month 3))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yune Zhao

Clinical Professor

Wenzhou Medical University

研究点 (1)

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