An observational study in Ametropia, Myopia and Hyperopia, sponsored by Alcon Research. Terminated at 1 site in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by Alcon Research · Observational
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.
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).
Subjects will be recruited from clinical sites located in the United States.
Key Inclusion Criteria:
Key Exclusion Criteria, as determined or known by the Investigator:
Lehfilcon A spherical contact lenses worn in both eyes in a real-world setting
Device: Lehfilcon A spherical contact lenses
Lehfilcon A toric contact lenses worn in both eyes in a real-world setting
Device: Lehfilcon A toric contact lenses
Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia)
Also known as: TOTAL30® Spherical Contact Lenses
Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia) with astigmatism
Also known as: TOTAL30® for Astigmatism Contact Lenses
Distance visual acuity with study lenses at baseline
Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.
Time frame: Baseline
Distance visual acuity with study lenses at 1-year follow-up
Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.
Time frame: Year 1
Incidence of corneal infiltrative events
Incidence of corneal infiltrative events occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam).
Time frame: Up to Year 1
Incidence of microbial keratitis
Incidence of microbial keratitis occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam).
Time frame: Up to Year 1
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Alcon Research