Post-Market Study of Alcon Intraocular Lenses

• Sponsor: Alcon Research (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05414565
• Collaborator: Queensland University of Technology (Other)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: Vivity IOL; Device: Aspheric monofocal IOL

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 Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Clinical and Functional Performance of Acrysof IQ Vivity Versus Aspheric Monofocal IOLs
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Binocular photopic best-corrected distance visual acuity (BCDVA) [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Optometry and Vision Science, Queensland University of Technology	Kelvin Grove	Queensland	Australia	4059

Sponsors and Collaborators

• Alcon Research
• Queensland University of Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT05414565
• Other Study ID Numbers: A04429
• First Posted: Jun 10, 2022
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 12, 2022