Guangke Lenses in Congenital Cataract
Investigation of Guangke Lenses' Efficacy in Delaying Myopia Onset/Progression in Postoperative Congenital Cataract Children
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Jin Yang, Dr.
- Telefonnummer: 021-64377134
- E-mail: jin_er76@hotmail.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200031
- Rekruttering
- Eye & ENT Hospital of Fudan University
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Kontakt:
- Jin Yang, PhD
- Telefonnummer: 13671632525
- E-mail: jin_er76@hotmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Active Comparator: Conventional Bifocal Lenses
Participants in this arm will wear conventional bifocal spectacles (without defocus design).
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Standard conventional bifocal spectacles without peripheral defocus design.
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Eksperimentel: Experimental: Individually Customized Bifocal + Defocus Lenses
Participants in this arm will wear individually customized bifocal spectacles with peripheral defocus design.
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Individually customized bifocal spectacles with peripheral defocus design for myopia control.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Axial Length (AL)
Tidsramme: Baseline to 12 months
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Change in axial length (in millimeters) from baseline measured by optical biometry.
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Baseline to 12 months
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Change in Spherical Equivalent Refraction (SER)
Tidsramme: Baseline to 12 months
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Change in spherical equivalent refraction (in diopters) measured by cycloplegic autorefraction from baseline.
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Baseline to 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Corneal Curvature
Tidsramme: Baseline to 12 months
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Change in corneal curvature (in millimeters) measured by corneal topography.
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Baseline to 12 months
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Change in Intraocular Pressure (IOP)
Tidsramme: Baseline to 12 months
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Change in IOP (in mmHg) measured by non-contact tonometry.
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Baseline to 12 months
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Incidence of Adverse Events
Tidsramme: Baseline to 12 months
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Number of participants with ocular or systemic adverse events related to the study lenses.
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Baseline to 12 months
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Guangke lenses_2025
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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