Visual Acuity
Conditions
Brief summary
The purpose of the study is to evaluate clinical and functional performance in real-world conditions in participants who have been implanted with Acrysof IQ Vivity (Extended Vision) IOLs compared with Alcon Aspheric Monofocal IOLs.
Detailed description
This observational study will enroll subjects who have been implanted with an Alcon aspheric monofocal or monofocal toric IOL no less than 4 months prior to study procedures. This study will be conducted in Australia.
Interventions
DEVICEVivity IOL
Commercially available extended vision IOL
DEVICEAspheric monofocal IOL
Commercially available aspheric IOL
Sponsors
Queensland University of Technology
Alcon Research
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * In good general health at the screening visit; * Implanted in both eyes at least 4 months ago with either Vivity/Vivity toric IOL or an Alcon aspheric monofocal/monofocal toric IOL (Acrysof IQ/Clareon); * Best Corrected Distance Visual Acuity (BCDVA) of 20/25 or better with both eyes together; * BCDVA of 20/40 or better in each eye; Key
Exclusion criteria
* Clinically significant Posterior Capsular Opacity (PCO) as assessed via slit-lamp exam per investigator opinion; * History of ocular surgery other than cataract surgery and Nd:YAG laser surgery; * History of amblyopia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular photopic best-corrected distance visual acuity (BCDVA) | At least 4 months post-operative | Visual acuity will be measured using a standard visual acuity chart at a distance of 4 meters under photopic (well-lit) conditions and reported in logarithm Minimum Angle of Resolution (logMAR) units. Visual acuity will be measured binocularly (both eyes together). |
Countries
Australia
Outcome results
None listed