This study aims to investigate whether individually customized bifocal + defocus spectacles can slow myopic shift in children after congenital cataract surgery.
Children with congenital cataract who have undergone surgery will be fitted with individually customized bifocal + defocus spectacles. Refraction and axial length will be monitored at regular intervals to assess the effect of the intervention on myopic progression.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Standard conventional bifocal spectacles without peripheral defocus design.
Individually customized bifocal spectacles with peripheral defocus design for myopia control.
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGChange in Axial Length (AL)
Change in axial length (in millimeters) from baseline measured by optical biometry.
Time frame: Baseline to 12 months
Change in Spherical Equivalent Refraction (SER)
Change in spherical equivalent refraction (in diopters) measured by cycloplegic autorefraction from baseline.
Time frame: Baseline to 12 months
Change in Corneal Curvature
Change in corneal curvature (in millimeters) measured by corneal topography.
Time frame: Baseline to 12 months
Change in Intraocular Pressure (IOP)
Change in IOP (in mmHg) measured by non-contact tonometry.
Time frame: Baseline to 12 months
Incidence of Adverse Events
Number of participants with ocular or systemic adverse events related to the study lenses.
Time frame: Baseline to 12 months
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