Congenital Cataract
Conditions
Keywords
Photochromic Lenses, Congenital Cataract, Axial length, Myopic shift
Brief summary
This study aims to investigate whether individually customized bifocal + defocus spectacles can slow myopic shift in children after congenital cataract surgery.
Detailed description
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.
Interventions
DEVICEConventional Bifocal Lenses
Standard conventional bifocal spectacles without peripheral defocus design.
DEVICEIndividually Customized Bifocal + Defocus Lenses
Individually customized bifocal spectacles with peripheral defocus design for myopia control.
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Corneal Curvature | Baseline to 12 months | Change in corneal curvature (in millimeters) measured by corneal topography. |
| Change in Intraocular Pressure (IOP) | Baseline to 12 months | Change in IOP (in mmHg) measured by non-contact tonometry. |
| Incidence of Adverse Events | Baseline to 12 months | Number of participants with ocular or systemic adverse events related to the study lenses. |
Countries
China
Contacts
CONTACTJin Yang, Dr.
Outcome results
None listed