Post-Market Study of Alcon Intraocular Lenses

Overview

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.

Full Title of Study: “Clinical and Functional Performance of Acrysof IQ Vivity Versus Aspheric Monofocal IOLs”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2023

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.

Interventions

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

Arms, Groups and Cohorts

  • Vivity IOL
    • Subjects previously implanted with Vivity or Vivity toric IOL
  • Aspheric Monofocal IOL
    • Subjects previously implanted with an aspheric monofocal or monofocal toric IOL

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Alcon Research
  • Collaborator
    • Queensland University of Technology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Director of Clinical Projects, Surgical, Study Director, Alcon Research, LLC
  • Overall Contact(s)
    • Jessie Hull, DrPH, +1 817-909-6199, jessie.hull@alcon.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.