The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.
This is a 3-year prospective, multicenter, randomized, and single-masked\*, parallel-group controlled clinical study. The purpose of this study is to evaluate the safety and efficacy of wearing Novel spectacle lenses to correct myopic ametropia, slow the progression of myopia and axial elongation in myopic children as compared to the use of single vision spectacles lenses. The treatment arms are: * Model A Novel spectacle lens * Model B Novel spectacle lens * Single vision spectacle lens Single-masked: The investigator responsible for conducting ocular data measurements related to the primary and secondary endpoints will be masked. The participants will not be informed the treatment arm during the clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
249
Model-A Novel spectacle lenses will be given to 1 arm to wear for 36 months
Model-B Novel spectacle lenses will be given to 1 arm to wear for 36 months
Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Guangzhou Aier Eye Hospital
Guangzhou, China
Eye and ENT Hospital of Fudan University
Shanghai, China
Shengyang He Eye Specialist Hospital
Shengyang, China
Axial length
The difference of Axial length changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants.
Time frame: 24 months
Spherical equivalent cycloplegic autorefraction
The difference of spherical equivalent cycloplegic autorefraction changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants
Time frame: 24 months
Axial length
Time frame: 36 months
Spherical equivalent cycloplegic autorefraction
Time frame: 36 months
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Tianjin Medical University Eye Hospital
Tianjin, China