Zhongshan Ophthalmic Center Sun Yat-Sen University
Guangdong, Guanzhou, 510060, China
NCT Number: NCT07706218
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.
Trial opening soon.
Get Notified0 year–6 year
All sexes
Observational
Guangdong, Guanzhou, 510060, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children unable to cooperate with examinations and follow-up visits.
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.
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
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
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.
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.
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
Contact information is provided by the study sponsor or research team.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Other
Acronym: PREC
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