Cohort Study on Refractive Errors in Preschool Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Refractive Errors. Basic parameters: 0 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Refractive error is a common visual disorder encompassing myopia, hyperopia, astigmatism and other subtypes. Refractive error in preschool children refers to refractive abnormalities occurring during the preschool period (0-6 years old). Studies conducted across diverse regions and populations report that the prevalence of refractive error among preschool children ranges approximately from 10% to 30%, with this proportion showing a gradual upward trend in recent years. Existing evidence suggests that preschool refractive status is correlated with multiple ocular and systemic diseases. Furthermore, the preschool years represent a highly sensitive window for children's visual development; uncorrected refractive errors at this stage can disrupt visual maturation and induce permanent visual impairment. Accordingly, identifying the full spectrum of comorbidities associated with preschool refractive error, alongside implementing early diagnosis and intervention, is clinically critical. Nevertheless, substantial challenges persist in the clinical management of preschool refractive errors: the complete comorbidity spectrum remains undefined, its natural history has not been fully elucidated, and high-quality evidence-based guidelines for refractive correction and visual rehabilitation are lacking. Establishing a prospective cohort of preschool children with refractive errors is therefore of great significance for clarifying disease progression and risk factors, generating evidence for standardized refractive interventions and visual rehabilitation protocols, and ultimately preventing visual impairment and improving quality of life in this vulnerable pediatric population. Our research team has previously completed preliminary investigations characterizing myopia in preschoolers. Building on this foundational work, we aim to construct a dedicated cohort of preschool children with refractive errors to delineate the natural history, progression risks and comorbidity profiles of preschool refractive error, and explore effective refractive correction and visual rehabilitation approaches for affected young children.
Primary outcome measures
- Ocular Biometry Parameters [Time frame: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months]
Secondary outcome measures (5)
- BCVA [Time frame: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months]
- Contrast Sensitivity [Time frame: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months]
- SER [Time frame: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months]
- WES (Whole Exome Sequencing) [Time frame: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months]
- OCT [Time frame: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months]
Eligibility criteria
Inclusion criteria
- Onset of refractive error occurs during preschool age (0-6 years old) supported by retrievable medical records;
- Spherical equivalent power ≤ -0.50 D or ≥ +3.00 D in any meridian;
- Legal guardians agree to participate and sign written informed consent.
Exclusion criteria
Children unable to cooperate with examinations and follow-up visits.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhongshan Ophthalmic Center Sun Yat-Sen University — Guangdong
Identifiers
NCT: NCT07706218 · 2023KYPJ340-2