This study will be a 3-phase, 12-months, prospective,single arm, multicenter, open-label, non-comparative, clinical investigation conducted at up to 7 sites. Up to 20 subjects will be enrolled in phase I, up to 30 subjects in phase II, and up to 200 subjects in phase 3 to achieve up to 350 treated eyes.
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Monocular Uncorrected Visual Acuity
Timeframe: 1 month
maintenance of Best Spectacle Corrected Visual Acuity
Timeframe: 12 months