Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric 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

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-14

Study Completion Date

2026-10-31

Brief Summary

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The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants who require cataract surgery in both eyes. The IOLs are designed to provide vision at far, arm's length, and near.

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Detailed Description

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Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. Both eyes will undergo cataract surgery. The second eye surgery will occur within 7 to 14 days of the first.

Conditions

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Aphakia Presbyopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clareon PanOptix Pro/Pro Toric Trifocal IOL

The clouded lens will be removed by phacoemulsification, after which the PanOptix Pro and/or PanOptix Pro Toric IOLs will be implanted.

Group Type EXPERIMENTAL

Clareon PanOptix Pro/Pro Toric Trifocal IOL

Intervention Type DEVICE

Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.

Phacoemulsification

Intervention Type PROCEDURE

Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for IOL implantation.

Interventions

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Clareon PanOptix Pro/Pro Toric Trifocal IOL

Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.

Intervention Type DEVICE

Phacoemulsification

Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for IOL implantation.

Intervention Type PROCEDURE

Other Intervention Names

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Clareon PanOptix Pro Trifocal IOL Models PXYWT0, PXCWT0, PXYAT0, PXCAT0 Clareon PanOptix Pro Trifocal Toric IOL Models PXYWT3- PXYWT6, PXCWT3-T6, PXYAT3-PXYAT6, PXCAT3-PXCAT6

Eligibility Criteria

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Inclusion Criteria

* Subjects with cataracts in both eyes, planned for removal by routine surgery (phacoemulsification);
* Subject must be able to understand and sign an approved informed consent form;
* Subject is willing to complete all the required study visits for the duration of the study;