Evaluation of Clareon Vivity/Vivity Toric

February 20, 2026 updated by: Alcon Research

PMCF (Post Market Clinical Follow-up) Evaluation of Clareon Vivity/Vivity Toric

This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Both eyes of a subject must qualify for enrollment into this study. A total of 2 scheduled visits are planned. The visits include a Screening visit (Visit 0) and a visit after screening (Visit 1). The subject must be 90-180 days post second eye implant at the time of Visit 1. Visit 1 should occur 1 to 14 days after Visit 0. Subject participation is expected to last approximately 2 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90505
        • Wolstan Goldberg Eye Associates
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Eye Center of Northern Colorado, PC
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Grosinger, Spigelman & Grey Eye Surgeons, P.C.
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704
        • Eye Care Specialists
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Carolina Eyecare Physicians LLC
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Understand and sign an approved Informed Consent form
  • Previously implanted in both eyes with Clareon Vivity/Clareon Vivity Toric or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 months (90 to 180 days) after second eye implant.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • History of clinically significant ocular co-morbidities that would affect surgical outcomes based on investigator expert medical opinion.
  • Subjects who were targeted to monovision defined as ≥ 1.50 Diopter (D) of anisometropia.
  • Clinically significant PCO (posterior capsule opacification) affecting vision.
  • Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Clareon Vivity/Vivity Toric
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
Device: Clareon Vivity/Vivity Toric Extended Vision IOL
Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
Other Names:
  • Models CNWET0, CNWET3, CNWET4, CNWET5, CNWET6, CCWET0, CCWET3, CCWET4, CCWET5, CCWET6
  • Clareon Vivity™ Extended Vision Hydrophobic IOL
  • Clareon Vivity™ Toric Extended Vision Hydrophobic IOL
Active Comparator: Clareon Monofocal/Clareon Toric
Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
Device: Clareon Monofocal/Clareon Toric IOL
Single vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
Other Names:
  • SY60WF, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, Clareon with AutonoMe (CCA0T0, CNA0T0)
  • Clareon™ Aspheric Hydrophobic Acrylic IOL
  • Clareon™ Toric Aspheric Hydrophobic Acrylic IOL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Time Frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Visual acuity (VA) was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters (m) using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.
Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Time Frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.
Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Time Frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 40 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together.
Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Time Frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The percentage was calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100. A higher percentage is a better outcome.
Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Lead, Surgical CRD, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILE632-C002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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