Cataract
Conditions
Brief summary
Evaluate the long-term (\>1 yr) outcomes of the Vivity IOL. The investigator will use similar measurements and procedures to the ones performed on these subjects during the FDA clinical trial.
Interventions
DEVICEVivity ACRYSOF IQ IOL Group
Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens
DEVICEACRYSOF IQ IOL Control Group
Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens
Sponsors
Alcon Research
The Eye Associates
Eye Care Specialists
NewsomeEye
John Berdahl, MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Must have participated in the FDA study at one of the included sites
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Distance Visual Acuity (BCDVAA) | After 1 year post-op | Best correct distance visual acuity |
| Best Corrected Intermediate Visual Acuity (BCIVA) | After 1 year post-op | Best correct intermediate visual acuity |
| Defocus Curve | After 1 year post-op | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative IOLSAT | After 1 year post-op | Questionnaire about satisfaction with your vision after surgery. 0-4 scale with 4 being the worse outcome |
| Uncorrected Distance Visual Acuity (UCDVA) | After 1 year post-op | Uncorrected Distance Visual Acuity |
| (Post-operative QUVID) | After 1 year post-op | Questionnaire about the quality of your vision after surgery.0-4 scale with 4 being the worse outcome |
| UCNVA | After 1 year post-op | Uncorrected Near Visual Acuity |
| Dyphotopsia rate | After 1 year post-op | Demonstrated by responses on questionnaire |
Countries
United States
Outcome results
None listed