Evaluation of Long-term Safety and Performance of PanOptix Intraocular Lens (IOLs)

Alcon

Status: Invitation-only

Conditions: Astigmatism; Presbyopia; Aphakia

Treatments: Device: AcrySof IQ PanOptix Toric IOL; Device: AcrySof IQ PanOptix IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT06166901

ILH297-I001

Details and patient eligibility

About

The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term safety and performance of the AcrySof PanOptix Trifocal toric and non-toric IOL models in subjects bilaterally implanted with these IOLs for 3 to 5 years. This study will be conducted in Spain.

Full description

Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. Prospective data will be collected at Visit 1, which will occur Year 3-5 postoperative.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject or legally authorized representative must be able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form.
• Subject must have had bilateral implantation of AcrySof PanOptix and/or AcrySof PanOptix Toric IOL models for 3 to 5 years prior to enrollment. A subject may have a Toric lens in one eye and a non-Toric in the fellow eye.
• Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.

Exclusion criteria

• Subject currently participating in another investigational drug or device study.
• Subject has had corneal refractive surgery after AcrySof PanOptix or AcrySof PanOptix Toric IOL implantation.
• Subject exposed to a study IOL for a minimum of 3 years prior to Visit 1 that have subsequently undergone an IOL exchange and are no longer implanted with a study IOL at the time of enrollment.
• Subject is pregnant or nursing at the time of enrollment.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

AcrySof IQ PanOptix IOL - Non Toric

Experimental group

Description:

Implantation with AcrySof IQ PanOptix non toric IOL in both eyes 3-5 years prior to enrollment

Treatment:

Device: AcrySof IQ PanOptix IOL

AcrySof IQ PanOptix IOL - Toric

Experimental group

Description:

Implantation with AcrySof IQ PanOptix IOL in both eyes 3-5 years prior to enrollment, with at least one of the eyes implanted with a toric AcrySof IQ PanOptix IOL

Treatment:

Device: AcrySof IQ PanOptix Toric IOL