Cohort Study on Refractive Errors in Preschool Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Ocular Biometry Parameters
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- BCVA(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(From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months)
- SER(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)(From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months)
- OCT(From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months)