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OpenTrials
Completed

NCT Number: NCT05414565

Post-Market Study of Alcon Intraocular Lenses

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.

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Key information

Conditions

Visual Acuity

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Optometry and Vision Science, Queensland University of Technology

Kelvin Grove, Queensland, 4059, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vivity IOL

Device

Commercially available extended vision IOL

Other names: Acrysof IQ Vivity or Vivity toric IOL

Aspheric monofocal IOL

Device

Commercially available aspheric IOL

Other names: Acrysof IQ monofocal or monofocal toric IOL, Clareon monofocal or monofocal toric IOL

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Collaborators

  • Queensland University of Technology

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2022
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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