MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms
Trial Parameters
Brief Summary
The purpose of this post-approval study is to confirm the effectiveness of the MiSight 1 Day lens in clinical practices within the US and to assess the stability of the myopia reduction over one-year post-treatment.
Eligibility Criteria
Inclusion Criteria: 1. Informed Consent and Assent have been completed 2. Be between 8 and 12 years of age inclusive at the time of enrollment. 3. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye 4. Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye. 5. Anisometropia: ≤ 1.50D SERE. 6. Astigmatism: ≤ 0.75 D 7. Free of ocular disease or abnormalities (including any corneal scar) 8. Currently have good general health. 9. Agree to accept the lens as assigned by the randomization. 10. Be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol. 11. Ability to comply with study procedures, including high and low (sub-study only) contrast high and low (sub-study only) lighting visual acuity, axial length, and cycloplegic auto-refraction measurements taken