An interventional study of Conventional Bifocal Lenses and Individually Customized Bifocal + Defocus Lenses in Congenital Cataract, sponsored by Eye & ENT Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 50 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
Exclusion Criteria:
Presence of any systemic disease (e.g., metabolic disorders, 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will wear conventional bifocal spectacles (without defocus design).
Device: Conventional Bifocal Lenses
Participants in this arm will wear individually customized bifocal spectacles with peripheral defocus design.
Device: Individually Customized Bifocal + Defocus Lenses
Standard conventional bifocal spectacles without peripheral defocus design.
Individually customized bifocal spectacles with peripheral defocus design for myopia control.
Change 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
Started Aug 2025 (actual). Primary completion is estimated for Aug 2028, 36 months after the start.
Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 36 months is above that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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