CClinicalTrials.gg
Status unknownNCT03589937Updated Mar 29, 2022

Ocular Development and Refractive Error Changes Among Children and Adolescent - A Longitudinal Study

An observational study in Myopia, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 2 sites in China. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-03-29.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7,050
Ages
3 Years to 12 Years
Sex
All
01

Study summary

The study aims to observe the ocular development and refractive error changes among school children and adolescents

Read the detailed description

This study aims to observe the refractive error changes of school children and adolescents for 3 years, and to collect data of ocular structural parameters, family history and environmental factors so as to understand the natural course and internal laws of myopia progression.

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Conditions studied

  • Myopia

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Keywords

  • refractive error
  • ocular structural parameters
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In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 7,050 is above the median of 150 across 107 observational studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7)

Inclusion criteria

  • School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7).
  • No allergy to tropicamide or topical anesthetics
  • written informed consent is obtained from guardian
  • Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.

Exclusion criteria

Exclusion Criteria:

  • No history of eye diseases
  • Receiving or has been received treatment of myopia control such as atropine eye drops, corneal contact lens or myopic glasses
  • A history of allergy to topic amide or topical anesthetics
  • Have severe systemic disease
  • Missing ability to give informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7,050 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. spherical equivalent change

    SE was measured by autorefractometer with cycloplegic once a year at scheduled time Every 12 months, follow up for 3 years

    Time frame: examine every 12 months, follow up for 3 years

Secondary outcomes

  1. Axial length

    Axial length is measured by IOMaster once a year at scheduled time

    Time frame: examine every 12 months, follow up for 3 years

  2. Anterior chamber depth

    Anterior chamber depth is measured by IOMaster once a year at scheduled time

    Time frame: examine every 12 months, follow up for 3 years

  3. lens thickness

    lens thickness is measured by IOMaster once a year at scheduled time

    Time frame: examine every 12 months, follow up for 3 years

  4. Vitreous length

    Vitreous length was measured by IOMaster once a year at scheduled time

    Time frame: examine every 12 months, follow up for 3 years

  5. Environmental factor

    Time of outdoor activities \& short range reading,measured by questionnaire

    Time frame: examine every 12 months, follow up for 3 years

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Study locations

2 sites
  • Zengcheng
    Guangzhou, Guangdong 510000, China
  • Zengcheng
    Guangzhou, Guangdong, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03589937
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Responsible party
Yizhi Liu (Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University) — Principal investigator
First posted
Jul 18, 2018
Start date
Jul 20, 2018
Primary completion
Jul 20, 2024 (estimated)
Completion
Jul 20, 2024 (estimated)
Last update
Mar 29, 2022

Study contacts

Yizhi LIU, PhD
principal investigator · Zhongshan Ophthalmic Center, Sun Yat-san University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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