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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-27

Study Completion Date

2025-02-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aphakia Astigmatism Presbyopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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AcrySof IQ PanOptix IOL - Non Toric

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

Group Type EXPERIMENTAL

AcrySof IQ PanOptix IOL

Intervention Type DEVICE

Trifocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism, with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence.

AcrySof IQ PanOptix IOL - Toric

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

Group Type EXPERIMENTAL

AcrySof IQ PanOptix Toric IOL

Intervention Type DEVICE

Toric trifocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence.

Interventions

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AcrySof IQ PanOptix IOL

Trifocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism, with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence.

Intervention Type DEVICE

AcrySof IQ PanOptix Toric IOL

Toric trifocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence.

Intervention Type DEVICE

Other Intervention Names

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Model TFNT00 Models TFNT20, TFNT30, TFNT40, TFNT50, TFNT60

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No