Bullous Keratopathy, Corneal Erosion, Entropion, Corneal Edema, Corneal Dystrophy
Conditions
Keywords
Bandage lens
Brief summary
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.
Detailed description
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.
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
* Diagnosis of a corneal condition with pain for which AONDA or PV2 contact lenses were placed on one or both eye(s) as a therapeutic contact lens at Baseline. * Baseline and Follow-up (up to 1 year from Baseline) charts available. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic CL wear or confounds study results during the data collection period. * Used systemic or ocular medication that would confound study results during the data collection period. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in corneal pain at the Follow-up Visit - Primary exposure | 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 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. |
Countries
United States
Outcome results
None listed