Post-Market Study of Alcon Intraocular Lenses

Visual Acuity Clinical Trial

Official title:

Clinical and Functional Performance of Acrysof IQ Vivity Versus Aspheric Monofocal IOLs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05414565
• Other study ID #: A04429
• Status: Recruiting
• Start date: September 15, 2022
• Est. completion date: March 2024

Study information

• Verified date: October 2023
• Source: Alcon Research
• Contact: Jessie Hull, DrPH
• Phone: +1 817-909-6199
• Email: jessie.hull[@]alcon.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• Vivity IOL
Commercially available extended vision IOL
• Aspheric monofocal IOL
Commercially available aspheric IOL

Locations

Country	Name	City	State
Australia	School of Optometry and Vision Science, Queensland University of Technology	Kelvin Grove	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Alcon Research	Queensland University of Technology

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular photopic best-corrected distance visual acuity (BCDVA)	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).	At least 4 months post-operative