跳至主要内容
临床试验/NCT04263636
NCT04263636已完成不适用

Introduction of a Modified Luminous Efficiency Function V(λ)' That Addresses Total Light Transmittance of Patients That Underwent Pseudophakic Presbyopic Corrections

Democritus University of Thrace1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Minimum light intensity

研究概览

简要总结

Primary objective of this study is to construct and validate a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients that underwent bilateral pseudophakic presbyopic correction with trifocal intraocular lenses (IOLs) implantations.

详细描述

Present study aims to identify in which degree multifocal IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following bilateral pseudophakic presbyopic corrections. Specifically, the aim of this study is to identify the minimum light intensity in which patients that underwent pseudophakic presbyopic correction with trifocal IOLs can reach their maximum visual acuity (measured when lights are at the 100% lighting level)

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
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 45 to 70 years

排除标准

  • astigmatism >1.00 diopters
  • former incisional eye surgery
  • corneal or fundus disease
  • diabetes mellitus
  • autoimmune diseases
  • neurological or psychiatric diseases
  • posterior capsule rupture or lens misalignment
  • postoperative uncorrected bilateral distant visual acuity < 8/10.

结局指标

主要结局

Minimum light intensity

时间窗: 6 months postoperatively

Minimum light intensity in which participants reach their maximum critical visual acuity

次要结局

  • Critical Visual Acuity (CVA)(6 months postoperatively)

研究者

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

Georgios Labiris

Associate Professor of Ophthalmology

Democritus University of Thrace

研究点 (1)

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