跳至主要内容
临床试验/NCT01351233
NCT01351233已完成不适用

Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
The position of IOL

研究概览

简要总结

The purpose of this study is to evaluate the stability and efficacy of The AcrySof Toric intraocular lens in the bag in high myopic subjects.

详细描述

According to numerous estimations, 15% to 29% of patients with cataract have≥1.5 diopters (D) of refractive astigmatism. New toric IOL designs (Acrysof © toric IOL; Alcon), approved by the US Food and Drug Administration (FDA) at the end of 2005, have been found to be more stable and safety in the capsular bag in subjects with normal axis length of eye. Then,this study aims at the confirmation of the stability of The AcrySof Toric intraocular lens in the bag in high myopic subjects.Then we may find a more effective treatment for the high myopic patients with complicated cataract and sever cornea astigmatism .

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sphere more than -6.0D;
  • Cornea astigmatism from -1.0 D to -4.0D;
  • Clinical diagnosis of complicated cataract;
  • Ask for and accept refractive lens exchange surgery;
  • Accept AcrySof Toric intraocular lens .

排除标准

  • Other eye diseases induces impaired vision ,such as retinal detachment,keratoconus,pterygium,glaucoma,choroidal detachment,vitreous hemorrhage,congenital cataract,lens dislocation,anterior uveitis ,pupil deformation and so on;
  • Previous corneal or intraocular surgery;
  • Refuse surgery;
  • Refuse to use AcrySof Toric intraocular lens .

结局指标

主要结局

The position of IOL

时间窗: 6 months

Postoperatively, with the patient sitting upright,the position of IOL was assessed by slit lamp。Then ,We would calculate the rotation of IOL .

次要结局

  • refraction astigmatism(6 months)

研究者

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

A-Yong Yu

Wenzhou Medical College, Ayong Yu MD,PhD Eye Hospital, Wenzhou Medical College, China.

Wenzhou Medical University

研究点 (1)

Loading locations...

相似试验