Guangke Lenses in Congenital Cataract
Investigation of Guangke Lenses' Efficacy in Delaying Myopia Onset/Progression in Postoperative Congenital Cataract Children
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jin Yang, Dr.
- Telefonnummer: 021-64377134
- E-post: jin_er76@hotmail.com
Studieorter
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200031
- Rekrytering
- Eye & ENT Hospital of Fudan University
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Kontakt:
- Jin Yang, PhD
- Telefonnummer: 13671632525
- E-post: jin_er76@hotmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Axial Length (AL)
Tidsram: 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)
Tidsram: Baseline to 12 months
|
Change in spherical equivalent refraction (in diopters) measured by cycloplegic autorefraction from baseline.
|
Baseline to 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Corneal Curvature
Tidsram: Baseline to 12 months
|
Change in corneal curvature (in millimeters) measured by corneal topography.
|
Baseline to 12 months
|
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Change in Intraocular Pressure (IOP)
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- Guangke lenses_2025
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