Cohort Study on Refractive Errors in Preschool Children
ConditionRefractive Errors
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-6
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Refractive error
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead sponsor
The People's Hospital of Ningxia
Collaborator
Source ClinicalTrials.gov
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