Post-Market Study of Alcon Intraocular Lenses

October 11, 2023 updated by: Alcon Research

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Kelvin Grove, Queensland, Australia, 4059
        • Recruiting
        • School of Optometry and Vision Science, Queensland University of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from ophthalmology practices who implant the Alcon Vivity and Alcon aspheric monofocal IOLs.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vivity IOL
Subjects previously implanted with Vivity or Vivity toric IOL
Device: Vivity IOL
Commercially available extended vision IOL
Other Names:
  • Acrysof IQ Vivity or Vivity toric IOL
Aspheric Monofocal IOL
Subjects previously implanted with an aspheric monofocal or monofocal toric IOL
Device: Aspheric monofocal IOL
Commercially available aspheric IOL
Other Names:
  • Acrysof IQ monofocal or monofocal toric IOL
  • Clareon monofocal or monofocal toric IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At least 4 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Collaborators

Queensland University of Technology

Investigators

  • Study Director: Director of Clinical Projects, Surgical, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

June 8, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • A04429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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