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The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.
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. Subjects/charts meeting the eligibility criteria will be enrolled in the study.
The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows:
The data collection period is defined as any approximately 3-year timeframe since and including 2009.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AONDA contact lenses | Lotrafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years |
| |
| PV2 contact lenses | Balafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon A contact lenses | Device | CE-marked silicone hydrogel contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance visual acuity | The subject's chart will be reviewed for distance visual acuity. | Year 3 |
| Incidence of corneal infiltrative events | The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the Baseline Visit exam. | Up to Year 3 |
| Incidence of microbial keratitis | The subject's chart will be reviewed for incidences of microbial keratitis occurring after the Baseline Visit exam. | Up to Year 3 |
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Key Inclusion Criteria:
Key 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 |
|---|---|---|---|---|---|---|
| Complete Family Vision Care | San Diego | California | 92123 | United States | ||
| Pearle Vision |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Balafilcon A contact lenses | Device | CE-marked silicone hydrogel contact lenses |
|
|
| Jacksonville |
| Florida |
| 32246 |
| United States |
| Jackson Health Community Center | Miami | Florida | 33126 | United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| Koetting Associates | St Louis | Missouri | 63144 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Smith Bowman Ophthalmology | Salt Lake City | Utah | 84117 | United States |