NCT06126302

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 6, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

5 days

First QC Date

November 6, 2023

Last Update Submit

November 6, 2023

Conditions

Keywords

Eye axial lengthCorneal curvatureBirth year-dependent

Outcome Measures

Primary Outcomes (2)

  • Eye Axial Length

    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.

    2023/10

  • Corneal Curvature

    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.

    2023/10

Study Arms (10)

Before 1930

the patients were divided into ten groups according to the decade of their birth: before 1930

Other: Birth year

1930-1939

the patients were divided into ten groups according to the decade of their birth: 1930-1939

Other: Birth year

1940-1949

the patients were divided into ten groups according to the decade of their birth: 1940-1949

Other: Birth year

1950-1959

the patients were divided into ten groups according to the decade of their birth: 1950-1959

Other: Birth year

1960-1969

the patients were divided into ten groups according to the decade of their birth: 1960-1969

Other: Birth year

1970-1979

the patients were divided into ten groups according to the decade of their birth: 1970-1979

Other: Birth year

1980-1989

the patients were divided into ten groups according to the decade of their birth: 1980-1989

Other: Birth year

1990-1999

the patients were divided into ten groups according to the decade of their birth: 1990-1999

Other: Birth year

2000-2009

the patients were divided into ten groups according to the decade of their birth: 2000-2009

Other: Birth year

after 2009

the patients were divided into ten groups according to the decade of their birth: after 2009

Other: Birth year

Interventions

we divided the patients according to patients' birth year

1930-19391940-19491950-19591960-19691970-19791980-19891990-19992000-2009Before 1930after 2009

Eligibility Criteria

Age7 Years - 130 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of ophthalmology, Zhongnan Hospital

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 13, 2023

Study Start

November 5, 2023

Primary Completion

November 10, 2023

Study Completion

November 20, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share