Refractive Errors
Conditions
Keywords
Contact Lenses, Overnight wear
Brief summary
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.
Detailed description
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 Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released. * The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed. The data collection period is defined as any approximately 3-year timeframe since and including 2009.
Interventions
CE-marked silicone hydrogel contact lenses
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: * Manifest refraction cylinder less than or equal to 0.75 diopter in each eye at baseline * Best corrected visual acuity of 20/25 or better in each eye at baseline * At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years * Baseline Visit and Year 3 Visit charts available Key
Exclusion criteria
* Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline * The use of systemic or ocular medications contraindicating regular contact lens wear at baseline * History of refractive surgery or irregular cornea * Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance visual acuity | Year 3 | The subject's chart will be reviewed for distance visual acuity. |
| Incidence of corneal infiltrative events | Up to Year 3 | The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the Baseline Visit exam. |
| Incidence of microbial keratitis | Up to Year 3 | The subject's chart will be reviewed for incidences of microbial keratitis occurring after the Baseline Visit exam. |
Countries
United States
Outcome results
None listed