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临床试验/NCT01786356
NCT01786356已完成不适用

Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two IOLs: Hoya iMics Y-60H vs. Bausch&Lomb MI60 (MIMI)

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
posterior capsular opacification (PCO)

研究概览

简要总结

Age-related cataract is the main cause of impaired vision in the elderly population worldwide.

The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.

The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.

Modifications in IOL design and material lead to a decrease in the incidence of PCO.

During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.

The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 4 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • bilateral age-related cataract
  • good overall physical constitution

排除标准

  • previous intraocular surgery or ocular trauma
  • intraocular complication like posterior capsular tear
  • corneal diseases, diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely

结局指标

主要结局

posterior capsular opacification (PCO)

时间窗: 4 years

subjective and objective PCO scoring

次要结局

  • best corrected visual acuity (BCVA)(4 years)
  • Nd:YAG rate(4 years)

研究者

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

Rupert Menapace

Ao.Univ.-Prof. Dr.med.univ.

Medical University of Vienna

研究点 (2)

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