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