跳至主要内容
临床试验/NCT06717607
NCT06717607已完成不适用

Comparing Visual Outcomes in Matched Patients Receiving a Low Cylinder Power Toric IOL or a Non-toric IOL

Ifocus Oyeklinikk2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
2
主要终点
Uncorrected distance visual acuity (UDVA)

研究概览

简要总结

The purpose of the study is to determine if visual function is improved with implantation of a low-cylinder toric intraocular lens, relative to a non-toric intraocular lens.

详细描述

The Clareon(R) T2 IOL and the Clareon (R) non-toric IOL will be randomly implanted in subjects determined to be appropriate for the T2 IOL. Visual acuity, low contrast acuity and contrast sensitivity will be measured 3 months postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • candidate for cataract surgery, suitable for implantation with a low cylinder toric IOL

排除标准

  • pathology that would confound outcomes, previous ocular surgery

结局指标

主要结局

Uncorrected distance visual acuity (UDVA)

时间窗: 3 months

UDVA (logMAR)

次要结局

  • Mean refraction, spherical equivalent (MRSE)(3 months)
  • Manifest refractive cylinder(3 months)
  • Percentage of eyes with <= 0.25 D of refractive cylinder(3 months)
  • Percentage of eyes with <= 0.50 D of refractive cylinder(3 months)
  • Corrected distance visual acuity(3 months)
  • Mesopic contrast sensitivity(3 months)
  • Photopic contrast sensitivity(3 months)
  • Low contrast visual acuity(3 months)

研究者

发起方
Ifocus Oyeklinikk
申办方类型
Network
责任方
Principal Investigator
主要研究者

Morten Gundersen

MD

Ifocus Oyeklinikk

研究点 (2)

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