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临床试验/NCT03831074
NCT03831074已完成不适用

Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses

Medical University of Vienna0 个研究点开始时间: 2012年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
主要终点
Posterior capsule opacification

研究概览

简要总结

The most frequent long-term complication of cataract surgery remains to be posterior capsule opacification (PCO). During the past decades many new intraocular lenses (IOL) with optimized lens material and design were introduced. We propose a study comparing three acrylic single-piece IOLs with different design and hydrophobic material. All IOLs (Hoya NY-60, HOYA Surgical Optics GmbH; EyeCee One, Nidek Co., Aichi, Japan) are commercially available and are used for routine cataract surgery. In this study a comparison of PCO score of all two IOLs, a comparison of optic quality with wavefront analyses, visual acuity, contrast sensitivity, IOL decentration and tilt, slitlamp examination, fibrosis, glistening intensity (subjectively scored), YAG capsulotomy rate, and safety parameters (IOL related adverse reactions) of the investigated IOLs will be performed. Since PCO develops slowly within years, a long-term follow-up of three years will be necessary.

As those IOLs are currently often implanted IOLs, their performance on PCO development and their optical quality is of high interest for the ophthalmologic community.

研究设计

研究类型
Interventional

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
  • •Age 40 and older
  • •Visual potential in both eyes of 20/30 or better as determined by investigators estimation
  • •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

排除标准

  • •Preceding ocular surgery or trauma
  • •Relevant other ophthalmic diseases (such as pseudoexfoliation, retinal degenerations, etc.)
  • •Uncontrolled systemic or ocular disease

结局指标

主要结局

Posterior capsule opacification

时间窗: 3 years

Posterior capsule opacification in the 2 IOLs will be assessed with semi automated quantification of cataract software

次要结局

未报告次要终点

研究者

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

Katharina Kriechbaum

Assoc. Prof. Dr.

Medical University of Vienna

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