跳至主要内容
临床试验/NCT01820065
NCT01820065已完成不适用

A Long-term Evaluation of Single-piece Hydrophobic Acrylic Intraocular Lens Implantation on the Development of Posterior Capsule Opacification

Iladevi Cataract and IOL Research Center1 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2005年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
390
试验地点
1
主要终点
Posterior Capsule Opacification

研究概览

简要总结

Although contemporary cataract surgery has made tremendous strides in technological advancement, posterior capsular opacification (PCO) is still the most frequent long-term complication leading to decreased visual functions and thereby dissatisfying results. A great deal of effort has been made to develop new ways to prevent the formation of PCO. A key factor, widely discussed in literature, is the material and design of the intraocular lense (IOL) edge that can lead to PCO prevention. It is still not clear whether the sharp-edged IOL produces less PCO because of its optic geometry alone or whether the biomaterial contributes to the inhibition of PCO. With the clinical introduction of the single-piece acrylic hydrophobic IOLs with some optic and haptic design differences compared with three-piece acrylic hydrophobic IOLs, it has become possible to determine the influence of IOL material and design on PCO prevention. It is well established that the development of PCO is a dynamic process and that a longer follow-up time is correlated with a higher degree of PCO. So far, there have been prospective clinical studies on the clinical results of single and three-piece acrylic hydrophobic foldable IOLs. However, the question as to as to whether the PCO further increases or becomes stable or regresses on a long-term basis has not yet been answered. Since there is paucity of available literature that prospectively evaluates the development of PCO with the implantation of the single-piece SN60AT hydrophobic acrylic IOL on a long-term basis, the investigators decided to observe the degree of development of PCO at 5 years after cataract surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with uncomplicated age-related cataract who were otherwise healthy

排除标准

  • a history of diabetes mellitus (DM),
  • patients with glaucoma,
  • high myopia (axial length > 27.0 mm),
  • pseudoexfoliation,
  • traumatic cataract,
  • subluxated cataract,
  • previous ocular surgeries, and
  • allergy to dilating drops.

结局指标

主要结局

Posterior Capsule Opacification

时间窗: 5 years followup

Evaluation of PCO (EPCO) scores in the area of the intraocular lens (IOL) optic and in the central 3mm zone at 5 years after surgery

次要结局

  • EPCO Score and EPCO area with total on and part on anterior capsulorhexis cover over optic(5 years postoperatively)

研究者

发起方
Iladevi Cataract and IOL Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abhay R. Vasavada

Director, Iladevi Cataract and IOL Research Center

Iladevi Cataract and IOL Research Center

研究点 (1)

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