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This study will be used to support assessment of AIR OPTIX® NIGHT & DAY® AQUA (AONDA) Soft Contact Lenses' safety and performance in accordance with updated European Union Medical Device Regulation (EU MDR) requirements.
In this retrospective observational study, the subject wore AONDA as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AONDA Therapeutic | Lotrafilcon A contact lenses worn therapeutically as a bandage lens 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 | 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 AONDA therapeutic contact lens was placed on eye as part of a treatment plan for an ocular condition. The Follow-up Visit is defined as the first visit where the AONDA 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. | Baseline, Follow-Up Visit (up to 1 year following the Baseline Visit) |
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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 |
|---|---|---|---|---|---|---|
| Vision Health Institute | Orlando | Florida | 32803 | United States | ||
| Franklin Park Eye Center PC |
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| Franklin Park |
| Illinois |
| 60131 |
| United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| ID | Term |
|---|---|
| D004774 | Entropion |
| D015715 | Corneal Edema |
| D003317 | Corneal Dystrophies, Hereditary |
| D003320 | Corneal Ulcer |
| D020330 | Bell Palsy |
| D007637 | Keratoconjunctivitis |
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D003316 | Corneal Diseases |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015817 | Eye Infections |
| D007239 | Infections |
| D007634 | Keratitis |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005155 | Facial Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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