Control of Myopia Using Novel Spectacle Lens Designs

Efficacy and Safety Study of Novel Spectacle Lens Designs to Control of Myopia

Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.

Inclusion Criteria:

• Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent
• SER error between -0.75 and -4.50 D
• SER power between the two eyes must be less than or equal to 1.50 D
• Willingness to participate in the trial for 3 years without content lens wear

Exclusion Criteria:

• Previous or current use of contact lenses
• Previous or current use of bifocals, progressive addition spectacles lenses
• Previous or current use of myopia control treatment
• Astigmatism worse then -1.25 DC in either eye