Bullous Keratopathy, Corneal Erosion, Entropion, Corneal Edema, Corneal Dystrophy, Corneal Ulcer, Foreign Body in Cornea, Bell Palsy, Keratoconjunctivitis, Filamentary Keratitis, Sicca Syndrome; Keratoconjunctivitis (Etiology)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
CE-marked silicone hydrogel contact lenses
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of a corneal condition with pain for which AONDA Soft Contact Lens as a therapeutic contact lens was placed on one or both eye(s) at Baseline. * Baseline and Follow-up (up to 1 year from Baseline) charts available. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic contact lens wear or confounds study results during the data collection period, as determined or known by the Investigator. * Used systemic or ocular medication that would confound study results during the data collection period, as determined or known by the Investigator. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in corneal pain at the Follow-up Visit | Baseline, Follow-Up Visit (up to 1 year following the Baseline 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. |
Countries
United States
Outcome results
None listed