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Cohort Study on Refractive Errors in Preschool Children

Cohort Study on Refractive Errors in Preschool Children

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07706218
Acronym
PREC
Enrollment
1000
Registered
2026-07-15
Start date
2026-08-01
Completion date
2028-12-01
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Errors

Keywords

Refractive error, preschool

Brief summary

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.

Interventions

None listed

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER
The People's Hospital of Ningxia
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

1. Onset of refractive error occurs during preschool age (0-6 years old) supported by retrievable medical records; 2. Spherical equivalent power ≤ -0.50 D or ≥ +3.00 D in any meridian; 3. Legal guardians agree to participate and sign written informed consent.

Exclusion criteria

Children unable to cooperate with examinations and follow-up visits.

Design outcomes

Primary

MeasureTime frameDescription
Ocular Biometry ParametersFrom date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 monthsA 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

MeasureTime frameDescription
BCVAFrom date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 monthsVisual Acuity Examination
Contrast SensitivityFrom date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 monthsCSF
SERFrom date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 monthsSpherical Equivalent Refraction,Comprehensive index reflecting overall ocular refractive status, integrating myopia, hyperopia and astigmatism.
WES (Whole Exome Sequencing)From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 monthsGenetic sequencing results of all protein-coding regions to detect gene variants related to refractive disorders.
OCTFrom date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 monthsOCT Imaging Findings

Countries

China

Contacts

CONTACTXiao Yang
yangx_zoc@163.com13760766303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026