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The purpose of this study is to support the safety and performance assessment of Air Optix Night and Day Aqua (AONDA) soft contact lenses for therapeutic use in accordance with updated EU Medical Device Regulation (MDR) requirements.
In this retrospective, real world evidence study, the subjects wore Air Optix Night and Day Aqua (AONDA) soft contact lenses or PureVision 2 (PV2) soft contact lenses as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes as part of their eye care professional's treatment and management plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AONDA contact lenses | Lotrafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional. |
| |
| PV2 contact lenses | Balafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in corneal pain at the Follow-up Visit - Primary exposure | The Investigator will review the subject's chart and document change from baseline in corneal pain at the Follow-up visit as "improved, similar, or worsened." The Baseline Visit is defined as the first visit where the therapeutic contact lens was placed on eye as part of a treatment plan for a corneal condition. The Follow-up Visit is defined as the first visit where the therapeutic contact lens was removed from the eye, or the first visit following the removal of the contact lens if, for example, the contact lens was removed between visits. The primary exposure is defined as the first exposure to the study lens if, for example, there were multiple exposures to the study lens. The data collection period consists of any timeframe since and including 2009. | Baseline, Follow-up Visit (up to 1 year following the Baseline Visit) |
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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 |
|---|---|---|---|---|---|---|
| Delray Physician Care Center | Delray Beach | Florida | 33445 | United States | ||
| Koetting Associates |
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| ID | Term |
|---|---|
| D004774 | Entropion |
| D015715 | Corneal Edema |
| D003317 | Corneal Dystrophies, Hereditary |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D003316 | Corneal Diseases |
| D015785 | Eye Diseases, Hereditary |
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| Balafilcon A contact lenses | Device | CE-marked silicone hydrogel contact lenses |
|
|
| St Louis |
| Missouri |
| 63144 |
| United States |
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |