Investigation of Guangke Lenses' Efficacy in Delaying Myopia Onset/Progression in Postoperative Congenital Cataract Children
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to investigate whether individually customized bifocal + defocus spectacles can slow myopic shift in children after congenital cataract surgery.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 12
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Eye & ENT Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Jin Yang, Dr.
jin_er76@hotmail.com
021-64377134
Time Frame
Start Date: 2025-08-06
Estimated Completion Date: 2030-08-06
Participants
Target number of participants: 50
Treatments
Active_comparator: Active Comparator: Conventional Bifocal Lenses
Participants in this arm will wear conventional bifocal spectacles (without defocus design).
Experimental: Experimental: Individually Customized Bifocal + Defocus Lenses
Participants in this arm will wear individually customized bifocal spectacles with peripheral defocus design.
Related Therapeutic Areas
Sponsors
Leads: Eye & ENT Hospital of Fudan University