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The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction.
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will review charts within their existing database to identify subjects who wore AONDA contact lenses or PureVision® 2 (PV2) contact lenses in both eyes for approximately 1 year following their contact lens examination. The data collection period consists of any approximately 1-year timeframe since and including 2009.
The anticipated duration of the study is approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AONDA contact lenses | Lotrafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional |
| |
| PV2 contact lenses | Balafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon A contact lenses | Device | CE-marked silicone hydrogel contact lenses for daily wear use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance visual acuity by eye | The subject's chart will be reviewed for distance visual acuity. | Year 1 |
| Incidence of corneal infiltrative events | The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. | Up to Year 1 |
| Incidence of microbial keratitis | The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. | Up to Year 1 |
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Inclusion Criteria:
Exclusion Criteria
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Investigators will enroll charts following a pre-identified process.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, CRD Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Balafilcon A contact lenses | Device | CE-marked silicone hydrogel contact lenses for daily wear use |
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