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NCT Number: NCT07706218

Cohort Study on Refractive Errors in Preschool Children

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.

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Key information

Age range

0 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center Sun Yat-Sen University

Guangdong, Guanzhou, 510060, China

Location contact

Xiao Yang

CONTACT

[email protected]

13760766303

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    A set of objective ocular structural measurements mainly including axial length (AL), alongside corneal curvature, anterior chamber depth, lens thickness and vitreous chamber depth. Axial length, the core indicator in this study, refers to the linear distance from the anterior corneal surface to the retinal pigment epithelium, which is closely associated with the onset and progression of refractive errors in preschool children. All biometric indices will be measured using standardized ophthalmic biometry equipment at each follow-up visit to dynamically observe the developmental rules of ocular dimensions and their correlation with refractive status.

Secondary outcomes

  1. 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

    Visual Acuity Examination

  2. 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

    CSF

  3. 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

    Spherical Equivalent Refraction,Comprehensive index reflecting overall ocular refractive status, integrating myopia, hyperopia and astigmatism.

  4. 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

    Genetic sequencing results of all protein-coding regions to detect gene variants related to refractive disorders.

  5. 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

    OCT Imaging Findings

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Yang

CONTACT

[email protected]

13760766303

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Collaborators

  • The People's Hospital of Ningxia

Registry information

Acronym: PREC

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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