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临床试验/NCT06345820
NCT06345820Unknown不适用

Intermediate Visual Acuity Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses

Vienna Institute for Research in Ocular Surgery2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年6月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
35
试验地点
2
主要终点
Monocular intermediate visual acuity

研究概览

简要总结

Comparison of the clinical performance of two enhanced monofocal IOLs with similar design.

详细描述

In modern cataract surgery the aim of the procedure is not just the restoration of vision but to also achieve some spectacle independence. Bilateral implantation of monofocal intraocular lenses (IOL) aiming for emmetropia lead to high patient satisfaction levels in distance vision but leave patients dependent on spectacles in intermediate and near vision tasks.

To achieve high levels of spectacle independence the most commonly used option are multifocal intraocular lenses (MIOL). These MIOLs use either a refractive or diffractive optical design, a combination of both or segmented asymmetric optics. Usually, the characteristic diffractive ring patterns are incorporated on the posterior surface of an IOL, whereas the anterior lens surface remains purely refractive. However, a portion of patients experience problems with positive dysphotopsia symptoms such as halos and glare. Other potentially negative aspects of MIOLs are pupil size dependency and loss of light energy to higher order diffraction which can lead to reduced contrast sensitivity. In clinical studies diffractive lenses resulted in a better outcome in terms of optical quality, better contrast sensitivity and positive dysphotopsia phenomena than refractive multifocal lenses.

A newer concept of IOLs are non-diffractive enhanced range of vision (EROV) IOLs, sometimes also referred to as EDOF IOLs. The EROV IOLs with the least compromise concerning quality of vision are the group of so called enhanced monofocal IOL, also sometime referred to as monofocal plus IOL. These IOLs should result in better intermediate vison and provide contrast sensitivity and dysphotopsia results comparable to standard monofocal IOLs. These IOLs may be more adequate to meet the expectations of many presbyopic cataract patients, who were used to have a good distance vision and who were wearing spectacles when performing near vision tasks before surgery.

The aim of this study is to compare the clinical performance of a newer enhanced monofocal IOL (Evolux) with a standard enhanced monofocal IOL, the Tecnis Eyhance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
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

  • Bilateral cataract
  • Age 21 or older
  • Visual acuity > 0.05
  • Axial length: 22.00-26.00mm
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Written informed consent prior to surgery
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures

排除标准

  • Active ocular disease (e.g. chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
  • Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS)
  • Corneal decompensation or corneal endothelial cell insufficiency
  • Amblyopia
  • Previous ocular surgery or trauma
  • Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
  • Astigmatism with the need for a toric IOL

结局指标

主要结局

Monocular intermediate visual acuity

时间窗: 24 months

Monocular intermediate visual acuity at 66 cm will be measured using ETDRS charts

次要结局

  • Monocular near visual acuity(24 months)
  • Monocular distance 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)

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