跳至主要内容
临床试验/NCT05347615
NCT05347615已完成不适用

The Implantation Of Monofocal And Premium IOL Models - A Registry Study At The Kepler University Hospital

Johannes Kepler University of Linz1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年10月10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
29
试验地点
1
主要终点
uncorrected intermediate distance visual acuity

研究概览

简要总结

Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at improving a patient's quality of life by reducing the need for spectacles in everyday life to a minimum. One way of achieving this goal is by using different lens technologies, such as a monofocal lens paired a lens with EDOF technology, as EDOF lenses provide an enhanced depth of focus by creating a single elongated focal point. As this "mix-and-match" is well established, the aim of this study is to compare the monofocal lens cohort to the EDOF lens cohort and evaluate visual acuity and patient satisfaction.

研究设计

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

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age between 21-99 years
  • signed consent form
  • senile cataract LOCS III grading
  • Cataract surgery with monofocal or premium lens implantation

排除标准

  • missing signed consent form
  • macular pathologies
  • corneal pathologies
  • irregular astigmatism
  • pregnancy

结局指标

主要结局

uncorrected intermediate distance visual acuity

时间窗: 24 months

Percentage of patients with uncorrected intermediate distance visual acuity of logMAR \>0.2

uncorrected distance visual acuity

时间窗: 24 months

Percentage of patients with uncorrected distance visual acuity of logMAR \>0.1

uncorrected near visual acuity

时间窗: 24 months

Percentage of patients with uncorrected near visual acuity of logMAR \>0.2

次要结局

  • Dysphotopsia(24 months)
  • PRISQ-Questionnaire(24 months)
  • Patient Satisfaction(24 months)

研究者

发起方
Johannes Kepler University of Linz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthias Bolz

Head of Ophthalmology

Johannes Kepler University of Linz

研究点 (1)

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