An observational study in Refractive Errors, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 0 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational
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.
420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 150 across 108 observational studies indexed under Refractive Errors.
Browse Refractive Errors studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study enrolls preschool children aged 0-6 years with refractive errors as the observation group. Eligible subjects meet the following inclusion criteria: refractive error onset during preschool period confirmed by available medical records, spherical power ≤ -0.50 D or ≥ +3.00 D in any meridian, and written informed consent provided by legal guardians. Children who cannot cooperate with ophthalmic examinations and long-term follow-up will be excluded.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children unable to cooperate with examinations and follow-up visits.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Refractive error in preschool children
Ocular Biometry Parameters
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
BCVA
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
Contrast Sensitivity
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
SER
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
WES (Whole Exome Sequencing)
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
OCT Imaging Findings
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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