跳至主要内容
临床试验/NCT05017376
NCT05017376已完成不适用

Evaluating the Effect of Optical Zones on Myopia and Astigmatism Correction in SMILE: Vector Analysis

Tianjin Eye Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年8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
140
试验地点
1
主要终点
astigmatic changes

研究概览

简要总结

Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction.

详细描述

To retrospectively study whether different surgical optical zone sizes affect the correction of diopter and astigmatism in myopia patients. Divided into 2 groups according to the diameter of the optical zone. The vector analysis method was used to analyze the changes and errors of astigmatism in TR and SIR after operation. Generalized Estimation Equation (GEE) model is used for multiple regression analysis to evaluate the potential factors related to the error value.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • no ocular conditions
  • normal topography
  • central corneal thickness, >500µm
  • residual stromal thickness, >280 µm
  • pupil diameter, 2.78-4.9 mm (average, 3.76±0.43 mm);

排除标准

  • history of intraocular surgery
  • pupil diameter, >4.9 mm or <2.78mm
  • keratoconus or corneal ectasia

结局指标

主要结局

astigmatic changes

时间窗: 2021.03

Observe the effect on changes in astigmatism by target induced astigmatism (TIA) versus surgically induced astigmatism (SIA)

error value

时间窗: 2021.04

Target refraction (TR) and surgically induced refraction (SIR) under different optical zones

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Evaluating the Effect of Optical Zones on Correction... | 临床试验