MiSight 1 Day Safety Post-Approval Study
CooperVision, Inc.
Summary
The purpose of this post-approval study is to confirm the safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.
Description
This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.
Eligibility
- Age range
- 8–12 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Be between 8 and 12 years of age inclusive at the time of enrollment. 2. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.50 D and -7.00 D inclusive (at the corneal plane). 3. Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally 4. Free of ocular disease or abnormalities (including any corneal scar) 5. The parent/guardian must be capable of comprehending the nature of the study and consent to the use and release of their child's de-identified health care encounter data to be used for purposes of this…
Interventions
- DeviceMiSight 1 Day
Subjects will wear MiSight 1 day lenses for three years.
Locations (50)
- Experts on Sight LLC.Gilbert, Arizona
- Centerton Family EyecareCenterton, Arkansas
- University of California, Berkeley University Eye CenterBerkeley, California
- Golden Vision Cupertino OptometryCupertino, California
- Boghossian VisionDanville, California
- Iron Horse Optometric GroupDublin, California