Clinical and Functional Performance of Acrysof IQ Vivity Versus Aspheric Monofocal IOLs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Binocular photopic best-corrected distance visual acuity (BCDVA)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
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.
Outcomes
Primary Outcomes
Binocular photopic best-corrected distance visual acuity (BCDVA)
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported