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临床试验/NCT06126302
NCT06126302尚未招募不适用

Analyzing the Changes in Eye Axis Length and Corneal Curvature in Central China From the Perspective of Birth Year

Min Ke0 个研究点目标入组 60,000 人开始时间: 2023年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60,000
主要终点
Corneal Curvature

研究概览

简要总结

The Chinese lifestyle has undergone dramatic changes over the past century. In recent years, limited studies reported the changing trend in crucial eye parameters of people born in different decades. This multicenter study analyzed the axial length and average corneal curvature data from patients of four hospital. The trends in the axial length and corneal curvature will be observed.

详细描述

The Chinese lifestyle has undergone dramatic changes over the past century. In recent years, limited studies reported the changing trend in crucial eye parameters of people born in different decades. This multicenter study analyzed the axial length and average corneal curvature data between 2012 and 2023. There were four clinical centers involved in this study. The study was approved by the Medical Ethics Committee of Zhongnan Hospital, Wuhan University, Yichang center hospital, Jingzhou center hospital , Yichang center hospital and Xiaogan center hospital, and conformed to the tenets of the Declaration of Helsinki. We divided the participants into ten groups of 10 years each based on their year of birth (called birth decade) and observed the trends in the axial length and corneal curvature in different groups.

研究设计

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

入排标准

年龄范围
7 Years 至 130 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Eligible patients were those aged ≥7 years and who underwent intraocular lens (IOL) Master (version 5.5) biometry for routine examination of cataract or refractive examination (ametropia and presbyopia) between April 2012 and November October
  • •Only patients who would cooperate with examinations to ensure stable and repeatable data (AL was measured 5 times or more, CC was measured 3 times or more, and the coefficient of variation of the measured results were≤15%a coefficient of variation ≤15% was considered low variation) were selected.

排除标准

  • •Severe systemic disease, corneal diseases, severe dry eyes, serious fundus disease, noticeable lesions of the refractive stroma, inability to cooperate, or poor measurement quality (coefficient of variation> 15%) were the exclusion criteria.

结局指标

主要结局

Corneal Curvature

时间窗: 2023/10

The corneal curvature of all patients were measured using the IOL Master 5.5 (Carl Zeiss Meditec, Dublin, CA) biometry system for routine examination of cataracts or refractive examination (ametropia and presbyopia). Corneal curvature was measured in two meridians: flat keratometry (K1) and steep K (K2). The K value was the mean of K1 and K2. Corneal curvature was measured at least three times. In case of variations in values, measurements were repeated until reproducible results were obtained.

Eye Axial Length

时间窗: 2023/10

The Axial length of all patients were measured using the IOL Master 5.5 (Carl Zeiss Meditec, Dublin, CA) biometry system for routine examination of cataracts or refractive examination (ametropia and presbyopia).AL was measured as the distance from the tear film to the retinal pigment epithelium. The mean of 5 measurements wasas taken for final analyses.

次要结局

未报告次要终点

研究者

发起方
Min Ke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Min Ke

Department of ophthalmology, Zhongnan Hospital

Zhongnan Hospital

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