Status:
COMPLETED
Post-Market Study of Alcon Intraocular Lenses
Lead Sponsor:
Alcon Research
Collaborating Sponsors:
Queensland University of Technology
Conditions:
Visual Acuity
Eligibility:
All Genders
50-70 years
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...
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 conduc...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05414565
Start Date
September 15 2022
End Date
April 15 2024
Last Update
July 9 2024
Active Locations (1)
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1
School of Optometry and Vision Science, Queensland University of Technology
Kelvin Grove, Queensland, Australia, 4059