Ametropia, Myopia, Hyperopia, Astigmatism
Conditions
Keywords
Contact lenses
Brief summary
The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to continuously assess the visual performance and safety of TOTAL30 Sphere and TOTAL30 for Astigmatism contact lenses in a real-world setting across a broad variety of patients through routine clinical practices.
Detailed description
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 TOTAL30 sphere or toric contact lens prescription was released. Baseline visit data will be collected retrospectively (chart review). The Year 1 visit is defined as the visit that occurs 1 year (-2/+6 months) since the Baseline visit during which period the subject is wearing test lenses of the same design in both eyes, and a contact lens examination is performed. Year 1 data will be collected either retrospectively or prospectively (eye exam).
Interventions
DEVICELehfilcon A spherical contact lenses
Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia)
Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia) with astigmatism
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Inclusion criteria
Key Inclusion Criteria: * Wearers of lehfilcon A (sphere or toric) contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at the baseline timepoint; * Best corrected spectacle visual acuity (VA) 20/25 or better at baseline; * Healthy, non-diseased eyes; * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
, as determined or known by the Investigator: * Any ocular disease or condition that would contraindicate contact lens wear present at baseline; * The use of systemic or ocular medications that would contraindicate contact lens wear at baseline; * Participation in a contact lens or contact lens care product clinical trial during the period of the retrospective chart collection or during prospective study participation; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance visual acuity with study lenses at baseline | Baseline | Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place. |
| Distance visual acuity with study lenses at 1-year follow-up | Year 1 | Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place. |
| Incidence of corneal infiltrative events | Up to Year 1 | Incidence of corneal infiltrative events occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam). |
| Incidence of microbial keratitis | Up to Year 1 | Incidence of microbial keratitis occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam). |
Countries
United States
Outcome results
None listed