N/A
N=193
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
Aphakia
Bottom Line
View on ClinicalTrials.gov: NCT04098367 ↗Enrolled (actual)
193
Serious AEs
2.0%
Results posted
May 2022
Primary outcome: Primary: Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3) — 88.7; 58.1; 58.6 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VIVITY (Device); SYMFONY (Device); AT LARA (Device); Cataract surgery (Procedure)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3) |
88.7; 58.1; 58.6 | — |
| SECONDARY Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3) |
53.2; 55.6; 35.0 | — |
| SECONDARY Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3) |
79.0; 55.6; 38.3 | — |
Summary
The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.
Eligibility Criteria
Inclusion Criteria
- Planned cataract removal in both eyes.
- Willing and able to complete all required postoperative visits.
- Able to understand, read and write English and willing to sign an approved statement of informed consent.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding.
- Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol.
- Ocular trauma or ocular surface disease that would affect study measurements.
- Patients who desire monovision correction.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04098367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.