Conventional Bifocal Lenses: Standard conventional bifocal spectacles without peripheral defocus design.
Individually Customized Bifocal + Defocus Lenses: Individually customized bifocal spectacles with peripheral defocus design for myopia control.
Study summary
This study aims to investigate whether individually customized bifocal + defocus spectacles can slow myopic shift in children after congenital cataract surgery.
Eligibility
Sex
ALL
Min age
4 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria:
Aged 4 to 12 years (inclusive) at the time of enrollment. Diagnosed with bilateral congenital cataracts. Has undergone bilateral cataract extraction with intraocular lens (IOL) implantation.
Time since cataract surgery is between 1 to 6 months (inclusive) at the time of enrollment.
Able to undergo regular ophthalmic examinations (including refraction, axial length measurement, and intraocular pressure assessment).
Parent(s) or legal guardian(s) are willing and able to provide written informed consent.
Exclusion Criteria:
Presence of any systemic disease (e.g., metabolic disorders, autoimmune diseases, genetic syndromes, etc.).
Presence of any ocular disease other than congenital cataracts (e.g., glaucoma, uveitis, retinal disorders, corneal diseases, strabismus, amblyopia, etc.).
Previous or current use of myopia control treatments, including but not limited to atropine eye drops, orthokeratology (Ortho-K) lenses, or other myopia control spectacle lenses.
History of ocular trauma or intraocular surgery other than cataract extraction and IOL implantation.
Known allergy or hypersensitivity to any materials or components used in the study lenses.
Inability to comply with the study protocol or complete scheduled follow-up visits.
Participation in another interventional clinical trial within the past 30 days.
Primary outcome measure(s)
Change in Axial Length (AL) — Baseline to 12 months Change in axial length (in millimeters) from baseline measured by optical biometry.
Change in Spherical Equivalent Refraction (SER) — Baseline to 12 months Change in spherical equivalent refraction (in diopters) measured by cycloplegic autorefraction from baseline.
Trial sites (1)
Facility
City
Region
Status
Eye & ENT Hospital of Fudan University
Shanghai
Shanghai Municipality
Recruiting
More Eye & ENT Hospital of Fudan University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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