Post-Market Study of Alcon Intraocular Lenses

Alcon

Status: Completed

Conditions: Visual Acuity

Treatments: Device: Aspheric monofocal IOL; Device: Vivity IOL

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05414565

A04429

Details and patient eligibility

About

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 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.

Enrollment: 50 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

50 participants in 2 patient groups

Vivity IOL

Description:

Subjects previously implanted with Vivity or Vivity toric IOL

Treatment:

Device: Vivity IOL

Aspheric Monofocal IOL

Description:

Subjects previously implanted with an aspheric monofocal or monofocal toric IOL

Treatment:

Device: Aspheric monofocal IOL