MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms
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.
• Informed Consent and Assent have been completed
• Be between 8 and 12 years of age inclusive at the time of enrollment.
• 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
• Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
• Anisometropia: ≤ 1.50D SERE.
• Astigmatism: ≤ 0.75 D
• Free of ocular disease or abnormalities (including any corneal scar)
• Currently have good general health.
• Agree to accept the lens as assigned by the randomization.
⁃ Be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
⁃ 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 for both eyes.
⁃ Able to maintain the visit schedule.
⁃ Willingness to participate in the trial for 4 years.
⁃ Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
⁃ Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.