Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031, China
Location status: Recruiting
NCT Number: NCT07778797
This study aims to investigate whether individually customized bifocal + defocus spectacles can slow myopic shift in children after congenital cataract surgery.
Interested in participating?
Request Info4 year–12 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200031, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Standard conventional bifocal spectacles without peripheral defocus design.
Individually customized bifocal spectacles with peripheral defocus design for myopia control.
Time frame: Baseline to 12 months
Change in axial length (in millimeters) from baseline measured by optical biometry.
Time frame: Baseline to 12 months
Change in spherical equivalent refraction (in diopters) measured by cycloplegic autorefraction from baseline.
Time frame: Baseline to 12 months
Change in corneal curvature (in millimeters) measured by corneal topography.
Time frame: Baseline to 12 months
Change in IOP (in mmHg) measured by non-contact tonometry.
Time frame: Baseline to 12 months
Number of participants with ocular or systemic adverse events related to the study lenses.
Contact information is provided by the study sponsor or research team.
Eye & ENT Hospital of Fudan University
Other
Investigation of Guangke Lenses' Efficacy in Delaying Myopia Onset/Progression in Postoperative Congenital Cataract Children
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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