Myopia Clinical Trial
Official title:
The Effect of +3.00ADD on Myopia Progression in Chinese Children: A Cluster Randomized Controlled Clinical Trial
The purpose of this study is to evaluate the effect of +3.00ADD vs single vision spectacle on the progression of myopia in children. Many studies applying bifocals or multifocal spectacles to intervene the progression have been carried out based on the idea that myopia was caused by excessive accommodation, however, the effect was limited. The possible reason is that bifocal or multifocal spectacles still not fully adjust the accommodative error in myopia children.
The optical intervention has been extensively explored for the intervention of myopia
progression.
Based on the theory that myopia was caused by the excessive accommodative, bifocal or
multifocal spectacles for slowing the progression of myopia have been fully studied. Although
some studies' results showed statistically significant for slowing myopia progression with
multifocal spectacles, few had clinically meaningful, even in children with high
accommodative lag or near-point esophoria. The investigators think that the possible reason
for this clinical un-meaningful maybe that daily wearing bifocal or multifocal spectacles
still not fully adjust the accommodative error in children.
The aim of this randomized clinical trial is to evaluate myopic progression in children using
two spectacles (single-vision spectacles for distant vision, and +3.00ADD spectacle for near
vision), compared with control subjects wearing one spectacles (single-vision spectacles).
Myopia progression quantified by changes in axial length (AL) and cycloplegic spherical
equivalent refraction will be monitored for 3 years. The spectacles for intervention group
children will be adjusted based on the cycloplegic spherical equivalent and the extent of
accommodation lag for schedule time.
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