Refractive Errors, Myopia, Hyperopia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
CE-marked silicone hydrogel contact lenses for daily wear use
CE-marked silicone hydrogel contact lenses for daily wear use
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
* Normal eyes, as determined by the Investigator * At the time of the 1-year visit, subject was prescribed and wearing AONDA contact lenses or PV2 contact lenses in both eyes in a daily wear modality for at least approximately 1 year without changing wear modality * Baseline and 1-year visit charts available * Other protocol-specified inclusion criteria may apply
Exclusion criteria
* Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at Baseline * Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline * History of refractive surgery or irregular cornea * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance visual acuity by eye | Year 1 | The subject's chart will be reviewed for distance visual acuity. |
| Incidence of corneal infiltrative events | Up to Year 1 | The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. |
| Incidence of microbial keratitis | Up to Year 1 | The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. |
Countries
United States
Outcome results
None listed