跳至主要内容
临床试验/NCT05148741
NCT05148741已完成不适用

Evaluation of Capsular Bag Shape Changes After Plate-haptic Intraocular Lens Implantation by SS-OCT.

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7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
60
试验地点
1
主要终点
Capsular bend index (CBI)

研究概览

简要总结

Evaluation of capsular bag shape changes after plate-haptic intraocular lens implantation by SS-OCT.

详细描述

Eighty patients (80 eyes) with simple age-related cataracts were treated from December 2019 to December 2020 in the Wenzhou Medical University. Investigators specifically included patients who were bodily healthy and underwent a successful implantation of an IOL. Inclusion criteria for this study were patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.

排除标准

  • people cannot cooperate with the check, corneal opacity, glaucoma, and other eye diseases
  • any other previous intraocular surgery, and intraoperative complications including anterior or posterior capsulartears
  • Continuous circular capsulorhexis is not centered and Mydriasis is less than 7mm.

结局指标

主要结局

Capsular bend index (CBI)

时间窗: 2020.12.1

capsule bend formation has 5 continuous stages from 0 to 4,The stage score varies over different positions of the same capsule bag, because the capsule bend formation is inconsistent along the entire optic edge. CBI is the mean of the different stage scores in different positions and represents the general capsule bend state of the whole capsule bag.

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

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Wenzhou Medical University

研究点 (1)

Loading locations...

相似试验