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临床试验/NCT03921762
NCT03921762Unknown不适用

Comparison of Visual Outcomes After Bilateral Implantation of a New Extended Depth of Focus (EDOF) IOL Twinset With Bilateral Standard EDOF IOLs

Prim. Prof. Dr. Oliver Findl, MBA2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年10月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
28
试验地点
2
主要终点
Assessment of binocular near visual acuity

研究概览

简要总结

Comparison of the new extended depth of focus (EDOF) intraocular lens (IOL) ARTIS ACTIVE, which is designed as a twinset of IOLs, with the standard EDOF IOL AT Lara .

详细描述

Spectacle independence is a central aim in modern cataract surgery. Although bilateral monofocal IOL implantation, aiming for emmetropia or low myopia, leads to high levels of patient satisfaction in distance vision, spectacle dependence for reading and other near vision tasks is the usual result.

The option commonly used to achieve spectacle independence are multifocal intraocular lenses (IOLs). Multifocal IOLs either use a refractive or diffractive design or a combination of both or segmented asymmetric optics. The principal of the refractive design is based on changing the route of light rays by thickness, curvature and optical density of the lens. The principal of diffractive design is based on scattering of light rays when passing an edge in the material of the lens. Usually, the characteristic diffractive ring patterns are incorporated on the posterior surface of an IOL, whereas the anterior lens surface remains purely refractive. One potentially negative aspect of multifocal refractive IOLs is pupil size dependence, another is loss of light energy to higher order diffraction which is not useful for the patient. In clinical studies, diffractive lenses resulted in a better outcome in terms of optical quality, better contrast sensitivity, and less photic phenomena (dysphotopsia such as halos and glare) compared to refractive lenses.

Until recently multifocal lenses were typically bifocal with a focus assigned to near and a focus assigned to far vision. However, the intermediate working distance is poorly covered by the bifocal design. Since objects commonly viewed in this distance include computer displays and tablets, the intermediate distance has become a crucial part in daily life. Variations in the addition of power chosen for near vision provided some intermediate visual acuity, but still suboptimal. Therefore, a new concept of multifocality has been introduced, the trifocal lens. Trifocal IOLs provide three focal distances: far, intermediate, and near. This ideally results in even less spectacle dependence, including for computer work. However, one potential disadvantage of trifocal IOLs is slightly poorer near vision compared to bifocal IOLs with need for reading glasses for prolonged fine near work and loss of contrast sensitivity in the intermediate distance.

A better intermediate performance concerning contrast vision compared to trifocal IOLs can be reached using enhanced depth of focus (EDOF) lenses. These IOLs have an extended far focus area which reaches to the intermediate distance, providing high-quality vision over a continuous range of focus, rather than distinct foci with blur in between.

To provide similar outcomes to trifocal IOLs, mix-and-match of additions ("blended vision") is another option, in which additions of multifocal IOLs between both eyes differ. The idea behind it is to improve the contrast in the intermediate distance compared to trifocal IOLs. The combination of +1.75D/ +4D10 and +1.5D/ +3D11 successfully achieved a regular defocus curve, but patient's subjective binocular comfort was not determined. To preserve the binocular balance between the eyes, a difference in addition of 0.5D was proposed and the combination of +2.5D/ +3D showed similar results as trifocal IOLs, except in the intermediate range of -1D and -1.5D.

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
50 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 50 years old
  • Bilateral age-related cataract
  • Qualify for bilateral implantation within 1 month
  • No previous refractive or ocular surgery
  • Available IOL dioptre range: 18 to 27D
  • Expected postoperative astigmatism ≤ 0.75D

排除标准

  • Pupil > 4 mm
  • Occupation requiring night-time driving or any occupation incompatible with multifocality
  • Acute or chronic disease or illness that would increase risk or confound study results [e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma, epiretinal membrane, cornea guttata, etc....] found to be relevant by the investigators
  • Amblyopia, strabismus
  • Extremely shallow anterior chamber
  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, uveitis, Marfan's syndrome)
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/ scotopic conditions)
  • Instability to place the intraocular lens safely at the location planned
  • Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)

研究组 & 干预措施

Artis Active IOL

Experimental

Artis Active IOLs (Artis Active Mid, Artis Active Plus) will be implanted in patients eyes during cataract surgery

干预措施: Cataract surgery with Artis Active IOLs (Procedure)

AT Lara IOL

Experimental

AT Lara IOLs will be implanted in patients eyes during cataract surgery

干预措施: Cataract surgery with AT Lara IOLs (Procedure)

结局指标

主要结局

Assessment of binocular near visual acuity

时间窗: 12 months

Binocular near visual acuity in logMar will be measured at 40 cm distance using an ETDRS visual acuity chart

次要结局

  • Assessment of reading speed(12 months)
  • Assessment of halos(12 months)
  • Assessment of binocular far and intermediate visual acuity(12 months)
  • Assessment of binocular contrast sensitivity(12 months)

研究者

发起方
Prim. Prof. Dr. Oliver Findl, MBA
申办方类型
Other
责任方
Sponsor 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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