Cohort Study on Refractive Errors in Preschool Children (PREC)
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Xiao Yang
- Telefonnummer: 13760766303
- E-post: yangx_zoc@163.com
Studiesteder
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Guanzhou
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Guangdong, Guanzhou, Kina, 510060
- Zhongshan Ophthalmic Center Sun Yat-Sen University
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Ta kontakt med:
- Xiao Yang
- Telefonnummer: 13760766303
- E-post: yangx_zoc@163.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Refractive error
Refractive error in preschool children
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Ocular Biometry Parameters
Tidsramme: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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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.
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From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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BCVA
Tidsramme: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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Visual Acuity Examination
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From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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Contrast Sensitivity
Tidsramme: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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CSF
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From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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SER
Tidsramme: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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Spherical Equivalent Refraction，Comprehensive index reflecting overall ocular refractive status, integrating myopia, hyperopia and astigmatism.
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From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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WES (Whole Exome Sequencing)
Tidsramme: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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Genetic sequencing results of all protein-coding regions to detect gene variants related to refractive disorders.
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From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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OCT
Tidsramme: From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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OCT Imaging Findings
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From date of enrollment until the date of loss to follow-up from any cause, whichever came first, assessed up to 36 months
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2023KYPJ340-2
Plan for individuelle deltakerdata (IPD)
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