Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

Inclusion Criteria9

• Children 6 - 8 years of age (inclusive) at time of informed consent/assent;
• Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
• Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
• Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
• The difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 D;
• Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
• Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit;
• Willingness to participate in the trial for 24 months without contact lens wear;
• The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.