ClinicalTrials.gg
CompletedNCT05796453Updated Sep 2, 2026

Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix

An interventional study of Clareon Vivity IOL - Non Toric and Clareon Vivity IOL - Toric in Aphakia, Astigmatism and Presbyopia, sponsored by Alcon Research. Completed at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
470
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this Post-Market Clinical Follow-up study is to describe the long-term safety and performance of the Clareon Vivity and Vivity Toric and Clareon PanOptix and PanOptix Toric IOLs.

Read the detailed 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 from time of study enrollment through the Year 1 follow-up visit.

02

Conditions studied

  • Aphakia
  • Astigmatism
  • Presbyopia

Keywords

  • Cataract surgery
03

In context

Aphakia

69 studies on the registry are indexed under Aphakia; 6 are open to participants now.

This study's enrollment of 470 is above the median of 103 across 52 interventional studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Subject or legally authorized representative must be able to understand and sign an approved Form.
  • Subject must have had bilateral implantation of Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOLs between 3-6 months prior to enrollment.
  • Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Subject is currently participating in another drug or device study.
  • Subject has had corneal refractive surgery after Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOL implantation.
  • Subject is pregnant at the time of enrollment.
  • Other protocol-defined exclusion criteria may apply.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
470 participants (actual)

Study arms

  • Experimental
    Clareon Vivity IOL - Non Toric

    Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon Vivity IOL.

    Device: Clareon Vivity IOL - Non Toric

  • Experimental
    Clareon Vivity IOL - Toric

    Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon Vivity IOL.

    Device: Clareon Vivity IOL - Toric

  • Experimental
    Clareon PanOptix IOL - Non Toric

    Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon PanOptix IOL.

    Device: Clareon PanOptix Trifocal IOL - Non Toric

  • Experimental
    Clareon PanOptix IOL - Toric

    Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon PanOptix IOL.

    Device: Clareon PanOptix Trifocal IOL - Toric

Interventions

  • DeviceClareon Vivity IOL - Non Toric

    Spherical extended vision IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed.

    Also known as: Models CNWET0, CCWET0

  • DeviceClareon Vivity IOL - Toric

    Toric extended vision IOL implanted in the capsular bag of the eye for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients in whom a cataractous lens has been removed.

    Also known as: Models CNWET2, CNWET3, CNWET4, CNWET5, CNWET6, CCWET-2, CCWET3, CCWET4, CCWET3, CCWET3-T6

  • DeviceClareon PanOptix Trifocal IOL - Non Toric

    Spherical trifocal IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed.

    Also known as: Model CNWTT0, CCWTT2

  • DeviceClareon PanOptix Trifocal IOL - Toric

    Toric trifocal IOL implanted in the capsular bag of the eye for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients in whom a cataractous lens has been removed.

    Also known as: Models CNWTT2, CNWTT3, CNWTT4, CNWTT5, CNWTT6, CCWTT2, CCWTT3, CCWTT4, CCWTT5, and CCWTT6

06

What researchers measure

Primary outcomes

  1. Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit

    BCDVA will be assessed at a distance of 4 meters using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR).

    Time frame: Up to Year 3

  2. Number of Adverse Events

    Protocol-specified ocular adverse events will be assessed at each prospective visit and include the following: * Cystoid Macular Edema (CME) * Hypopyon * Endophthalmitis * Lens dislocation * Pupillary Block * Retinal Detachment * Secondary Surgical Interventions (Explantation/exchange/repositioning)

    Time frame: Up to Year 3

  3. Number of Device Deficiencies

    Device deficiencies will be assessed at each prospective visit. Examples include the following: * Failure to meet product specifications (e.g., incorrect IOL power) * IOL defect * Broken IOL optic * Broken IOL haptic * Scratched IOL optic * Unsealed device packaging * Suspected product contamination * Lack of performance

    Time frame: Up to Year 3

07

Study locations

7 sites
  • Wolstan & Goldberg Eye Associates
    Torrance, California 90505, United States
  • Levenson Eye Associates
    Jacksonville, Florida 32204, United States
  • Eye Surgeons of CNY
    Liverpool, New York 13088, United States
  • Tulsa Ophthalmology
    Tulsa, Oklahoma 74104, United States
  • Chu Eye Institute
    Fort Worth, Texas 76107, United States
  • The Eye Institute of Utah
    Salt Lake City, Utah 84107, United States
  • Centro Oftalmologico Metropolitano
    San Juan, 00921, Puerto Rico
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05796453
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Apr 3, 2023
Start date
Sep 19, 2023
Primary completion
Aug 21, 2026
Completion
Aug 21, 2026
Last update
Sep 2, 2026

Study contacts

Clinical Trial Lead, Surgical
study director · Alcon Research, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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