Clinical trial NCT06126302: Analyzing the Changes in Eye Axis Length and Corneal Curvature in Central China
Official title: Analyzing the Changes in Eye Axis Length and Corneal Curvature in Central China From the Perspective of Birth Year
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Birth Year-dependent Eye Parameters Change
Keywords: Eye axial length
Corneal curvature
Birth year-dependent
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 60000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 2023.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

- 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 2023. 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.

Exclusion Criteria:

- 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.

Primary outcomes:
measure: Eye Axial Length
timeFrame: 2023/10
measure: Corneal Curvature
timeFrame: 2023/10
Secondary outcomes:
Other outcomes:
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Study officials:
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