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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2,400
Subjects will wear MiSight 1 day lenses for three years.
Incidence of Microbial Keratitis (MK)
Incidence of Microbial Keratitis (MK) ≥ 1 mm
Time frame: 3 years
Incidence of peripheral infiltrative keratitis/non-infectious ulcers
Incidence of peripheral infiltrative keratitis/non-infectious ulcers ≤ 1 mm
Time frame: 3 years
Incidence of non-infectious infiltrative keratitis
Incidence of non-infectious infiltrative keratitis ≤ 1 mm
Time frame: 3 years
Incidence of loss of best-corrected visual acuity
Incidence of loss of best-corrected visual acuity ≥ 2 lines for any adjudicated adverse event.
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Experts on Sight LLC.
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