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Guangke Lenses in Congenital Cataract

RecruitingNA

Sponsor: Eye & ENT Hospital of Fudan University

Conditions: Congenital Cataract

Interventions: Conventional Bifocal Lenses, Individually Customized Bifocal + Defocus Lenses

Countries: China

This study aims to investigate whether individually customized bifocal + defocus spectacles can slow myopic shift in children after congenital cataract surgery.

Eligibility overview

Sex: ALL

Age: 4 Years to 12 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Shanghai, Shanghai Municipality, China