Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses

Alcon

Status

Not yet enrolling

Conditions

Presbyopia

Aphakia

Residual Refractive Cylinder

Treatments

Device: AcrySof IQ Vivity Extended Vision IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT06541795

ILI875-I001

Details and patient eligibility

About

The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.

Full description

This study includes a retrospective chart review to obtain preoperative, operative, and post-operative data, and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified IOLs for 3 to 5 years in the real world.

This study will be conducted in the US and in Spain.

Enrollment

210 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

22 years old or older at Visit 1.
Able to understand and sign an approved informed consent form.
Implantation of AcrySof IQ Vivity and/or Vivity Toric IOL models in both eyes for 3 to 5 years prior to enrollment.
Documented medical history and required pre-operative baseline information available for retrospective data collection.
Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation.
Pregnant or nursing at the time of enrollment.
Childbirth after IOL implantation.
Other protocol-specified exclusion criteria may apply.