Post-Market Study of Alcon Intraocular Lenses

NCT05414565 | Completed

• 1 other identifier: A04429
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Binocular photopic best-corrected distance visual acuity (BCDVA)

  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

Study Arms (2)

Vivity IOL

Subjects previously implanted with Vivity or Vivity toric IOL

Device: Vivity IOL

Aspheric Monofocal IOL

Subjects previously implanted with an aspheric monofocal or monofocal toric IOL

Device: Aspheric monofocal IOL

Interventions

Vivity IOL DEVICE

Commercially available extended vision IOL

Also known as: Acrysof IQ Vivity or Vivity toric IOL

Vivity IOL

Aspheric monofocal IOL DEVICE

Commercially available aspheric IOL

Also known as: Acrysof IQ monofocal or monofocal toric IOL, Clareon monofocal or monofocal toric IOL

Aspheric Monofocal IOL

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead
• Queensland University of Technology: collaborator

Study Sites (1)

School of Optometry and Vision Science, Queensland University of Technology

Kelvin Grove, Queensland, 4059, Australia

Location

Study Officials

• Director of Clinical Projects, Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 10, 2022
• Study Start: September 15, 2022
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)