跳至主要内容
临床试验/NCT04391972
NCT04391972Unknown不适用

Clinical Outcome of Extended-depth-of-focus Intraocualr Lens (SAV) Implantation

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2020年2月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
2
主要终点
Uncorrected near visual acuity

研究概览

简要总结

Clinical outcome of extended-depth-of-focus intraocular lens (SAV) implantation

详细描述

In this study, we are trying to evaluate the clinical outcome of extended-depth-of-focus intraocular lens (SAV).

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

  • Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye
  • Age-related cataract
  • A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
  • A patient want presbyopia correction at the same time as cataract surgery
  • A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
  • Written informed consent to surgery and participation in the study

排除标准

  • Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
  • Pregnant woman and lactating woman
  • A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
  • A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye
  • If expectations for presbyopia correction are too high
  • Those who are not able to read and understand the informed consent (illiterate or foreigners)

结局指标

主要结局

Uncorrected near visual acuity

时间窗: 3 months

Visual acuity at near with bare eyes

Uncorrected distant visual acuity

时间窗: 3 months

Visual acuity at distance with bare eyes

次要结局

  • Quality of Vision(3 months)
  • Contrast sensitivity(3 months)

研究者

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

tae-young chung

Professor

Samsung Medical Center

研究点 (2)

Loading locations...

相似试验