This is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles. A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
one of ZEISS BD spectacle lens designs 1 to 5
single vision lens
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, China
myopia progression
change in spherical equivalent from baseline for each of the groups of BD test lenses and the single vision control group
Time frame: 12 monthly
axial elongation
change in axial length from baseline for each of the groups of BD test lenses and the single vision control group
Time frame: 12 monthly
Subjective responses and compliance
Subjective visual responses of wearing spectacles and compliance using questionair for each groups
Time frame: 12 monthly
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