Guangke Lenses in Congenital Cataract
ConditionCongenital Cataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorEye & ENT Hospital of Fudan University
About this trial
This study aims to investigate whether individually customized bifocal + defocus spectacles can slow myopic shift in children after congenital cataract surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Bifocal Lenses
DeviceStandard conventional bifocal spectacles without peripheral defocus design.
Individually Customized Bifocal + Defocus Lenses
DeviceIndividually customized bifocal spectacles with peripheral defocus design for myopia control.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Active Comparator: Conventional Bifocal LensesActive comparator 1 intervention
Group B: Experimental: Individually Customized Bifocal + Defocus LensesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Axial Length (AL)
Change in axial length (in millimeters) from baseline measured by optical biometry.
Time frame
Baseline to 12 months2
Change in Spherical Equivalent Refraction (SER)
Change in spherical equivalent refraction (in diopters) measured by cycloplegic autorefraction from baseline.
Time frame
Baseline to 12 monthsSecondary outcomes
1
Change in Corneal Curvature
Change in corneal curvature (in millimeters) measured by corneal topography.
Time frame
Baseline to 12 months2
Change in Intraocular Pressure (IOP)
Change in IOP (in mmHg) measured by non-contact tonometry.
Time frame
Baseline to 12 months3
Incidence of Adverse Events
Number of participants with ocular or systemic adverse events related to the study lenses.
Time frame
Baseline to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov