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Clinical Trials in China / NCT07778797
Recruiting Not applicable

Guangke Lenses in Congenital Cataract

NCT07778797 · tracked via the Priya Life Science China tracker
Sponsor
Eye & ENT Hospital of Fudan University
Phase
Not applicable
Started
2025-08-06
Last updated
2026-08-21

Condition(s) studied

Congenital Cataract

Investigational drug(s) / intervention(s)

Conventional Bifocal LensesIndividually Customized Bifocal + Defocus Lenses

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)

Trial sites (1)

FacilityCityRegionStatus
Eye & ENT Hospital of Fudan University Shanghai Shanghai Municipality Recruiting

More Eye & ENT Hospital of Fudan University trials in China

Other trials for the same condition

Official registry record

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.

View NCT07778797 on ClinicalTrials.gov ↗ ← All trials in China