Post-Market Study of Alcon Intraocular Lenses

Completed

• Conditions: Visual Acuity
• Interventions: Device: Vivity IOL; Device: Aspheric monofocal IOL

• Registration Number: NCT05414565
• Lead Sponsor: Alcon Research

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 Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-10
• Study Start: 2022-09-15
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vivity IOL	Vivity IOL	Subjects previously implanted with Vivity or Vivity toric IOL
Aspheric Monofocal IOL	Aspheric monofocal IOL	Subjects previously implanted with an aspheric monofocal or monofocal toric IOL

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

School of Optometry and Vision Science, Queensland University of Technology; 🇦🇺 Kelvin Grove, Queensland, Australia