跳至主要内容
临床试验/NCT05194657
NCT05194657Unknown不适用

Assessment of Reading Performance in Patients With Acrysof IQ Vivity Toric or Non-toric vs Monofocal Acrysof IQ Toric or Non-toric IOL

Vienna Institute for Research in Ocular Surgery2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年1月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
68
试验地点
2
主要终点
Reading speed

研究概览

简要总结

Comparison of the visual function and reading performance between the Acrysof IQ Vivity IOL, an EDOF IOL, and the monofocal Acrysof IQ.

详细描述

With increasing demands of patients concerning their visual function after cataract surgery, a variety of advanced technology intraocular lenses (IOL) have become available in the last years. Various developments aim at a reduced spectacle independence for patients after cataract or refractive lens surgery.

Novel technology for providing an extended depth of focus (EDOF) has been developed to account for unmet needs of patients. A novel EDOF IOL, the Acrysof IQ Vivity, has two surface transition elements that work simultaneously by stretching and shifting the wavefront to create a continuous extended focal range instead of multiple focal points.

To assess the performance of such an IOL technology, most studies assess visual acuity at different distances from far, to intermediate up to near. Since most activites with digital devices implicate reading, it is not surprising that reading difficulty is the most common complaint among individuals experiencing visual disturbances with multifocal designs.

Reading ability is usually evaluated using various reading tests that assess reading speed and reading acuity defined as the print size that can stell be read with sufficient speed. However, one of the fundamental problems of these tests is that reading speed is also influenced by the average amount of time that a patient reads as well as the language of the text, whether it is the first or second language.

A novel method to analyse reading performance that appears to be more objective and less reliant on the cognitive abilities of the patient is the observation of the reading pattern using a high-speed eye-tracking system that analyses eye fixations during the reading test. In previous studies we have seen that several aspects of this reading patter, i.e. fixation duration and fixation frequency, appear to correlate with the reading performance overall and can be differentially used to discriminate between cognitive and visuo-motor processing.

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
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stereopsis
  • age 21 and older
  • regular corneal astigmatism of up to 3.0 D
  • written informed consent prior to surgery
  • normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • german as mother-tongue
  • calculated IOL power needed is below 15.0 D or above 25.0 D (no high myopia or high hypermetropia will be recruited)

排除标准

  • relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract, corneal scars, and other co-morbidity that could affect capsule bag stability (e.g. Marfan syndrome) or retinal diseases affecting visual acuity (AMD, Macular Pucker, post-operative macular edema...)
  • amblyopia
  • contact lenses
  • irregular corneal astigmatism on corneal topography
  • postoperative subjective refraction smaller/ higher than or 0.75 D
  • pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

结局指标

主要结局

Reading speed

时间窗: 24 months

reading speed will be assessed with the Eyetracker device at 66 centimetres and will be compared between the EDOF IOL and the monofocal IOL

次要结局

  • Visual acuity(24 months)

研究者

发起方
Vienna Institute for Research in Ocular Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

研究点 (2)

Loading locations...

相似试验