Guangke Lenses in Congenital Cataract
Investigation of Guangke Lenses' Efficacy in Delaying Myopia Onset/Progression in Postoperative Congenital Cataract Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jin Yang, Dr.
- Phone Number: 021-64377134
- Email: jin_er76@hotmail.com
Study Locations
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200031
- Recruiting
- Eye & ENT Hospital of Fudan University
-
Contact:
- Jin Yang, PhD
- Phone Number: 13671632525
- Email: jin_er76@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active Comparator: Conventional Bifocal Lenses
Participants in this arm will wear conventional bifocal spectacles (without defocus design).
|
Standard conventional bifocal spectacles without peripheral defocus design.
|
|
Experimental: Experimental: Individually Customized Bifocal + Defocus Lenses
Participants in this arm will wear individually customized bifocal spectacles with peripheral defocus design.
|
Individually customized bifocal spectacles with peripheral defocus design for myopia control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Axial Length (AL)
Time Frame: Baseline to 12 months
|
Change in axial length (in millimeters) from baseline measured by optical biometry.
|
Baseline to 12 months
|
|
Change in Spherical Equivalent Refraction (SER)
Time Frame: Baseline to 12 months
|
Change in spherical equivalent refraction (in diopters) measured by cycloplegic autorefraction from baseline.
|
Baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Corneal Curvature
Time Frame: Baseline to 12 months
|
Change in corneal curvature (in millimeters) measured by corneal topography.
|
Baseline to 12 months
|
|
Change in Intraocular Pressure (IOP)
Time Frame: Baseline to 12 months
|
Change in IOP (in mmHg) measured by non-contact tonometry.
|
Baseline to 12 months
|
|
Incidence of Adverse Events
Time Frame: Baseline to 12 months
|
Number of participants with ocular or systemic adverse events related to the study lenses.
|
Baseline to 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Guangke lenses_2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.