The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as extended (overnight) wear.
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The data collection period is defined as any approximately 1-year to 3-year timeframe since the respective lens brand was prescribed.
Study Type
OBSERVATIONAL
Enrollment
505
Commercially available silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
Vision Health Institute
Orlando, Florida, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Koetting Associates
St Louis, Missouri, United States
Smith Bowman Ophthalmology
Salt Lake City, Utah, United States
Distance visual acuity (VA) with study lenses at Year 1
The subject's chart will be reviewed for distance visual acuity at Year 1, defined as a visit which occurred 1 year (-2/+4 months) since baseline during which period the subject was wearing either the study or comparator lenses and a contact lens examination was performed. The Baseline visit is defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient before or during which a contact lens prescription for the study or comparator contact lens (lotrafilcon B or comfilcon A) was released.
Time frame: Year 1
Distance visual acuity (VA) with study lenses at Year 3
The subject's chart will be reviewed for distance visual acuity at Year 3, defined as a visit which occurred 3 years (-2/+8 months) since baseline during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed.
Time frame: Year 3
Incidence of corneal infiltrative events
The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam.
Time frame: Up to Year 3
Incidence of microbial keratitis
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.
Time frame: Up to Year 3
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Commercially available silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses