The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix plus HydraGlyde Multifocal soft contact lenses in a real-world setting when worn as daily wear or 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. The baseline visit will be 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 lenses was released. Subjects/charts meeting the eligibility criteria will be enrolled in the study.
Study Type
OBSERVATIONAL
Enrollment
351
Commercially available soft (hydrophilic) contact lenses indicated for the correction of presbyopia, with or without myopia or hyperopia
Commercially available soft (hydrophilic) contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia
Complete Family Vision Care
San Diego, California, United States
Pearle Vision
Jacksonville, Florida, United States
Jackson Health Community Center
Miami, Florida, United States
Vision Health Institute
Orlando, Florida, United States
Distance visual acuity at 1 year - Daily Wear
The subject's chart will be reviewed for distance visual acuity at Year 1, defined as the visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).
Time frame: Year 1
Near visual acuity at 1 year - Daily Wear
The subject's chart will be reviewed for near visual acuity at Year 1, defined as the visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).
Time frame: Year 1
Distance visual acuity at 3 years - Extended Wear
The subject's chart will be reviewed for distance visual acuity at Year 3, defined as the 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. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).
Time frame: Year 3
Near visual acuity at 3 years - Extended Wear
The subject's chart will be reviewed for near visual acuity at Year 3, defined as the 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. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).
Time frame: Year 3
Incidence of corneal infiltrative events - Daily Wear
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Complete Eye Care of Medina
Medina, Minnesota, United States
Koetting Associates
St Louis, Missouri, United States
Sacco Eye Group
Vestal, New York, United States
Smith Bowman Ophthalmology
Salt Lake City, Utah, United States
The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).
Time frame: Up to Year 1
Incidence of corneal infiltrative events - Extended Wear
The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).
Time frame: Up to Year 3
Incidence of microbial keratitis - Daily Wear
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).
Time frame: Up to Year 1
Incidence of microbial keratitis - Extended Wear
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).
Time frame: Up to Year 3