Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs)

July 10, 2026 updated by: Alcon Research

Evaluation of the Impact of Residual Astigmatism on the Visual Performance With Clareon Vivity

The purpose of this study is to generate clinical data to quantify the impact of residual astigmatism on the overall visual performance during distance, intermediate, and near viewing in patients implanted with Clareon Vivity IOLs.

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

This single visit study is designed to help understand how vision is affected if the eye still has astigmatism after cataract surgery. Participants will be individuals who have already undergone cataract surgery and received a Clareon Vivity IOL in both eyes at least 4 months prior to study enrollment. During the study visit, trial lenses (glass lenses that are used during an eye exam) will be used to temporarily create the effect of astigmatism on the eye.

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.
40

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
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Grosinger, Spigelman & Grey Eye Surgeons, P.C
    • Texas
      • Dallas, Texas, United States, 75243
        • Key-Whitman Eye Center
      • Sugar Land, Texas, United States, 77478
        • Berkeley Eye Center

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

Inclusion Criteria:

  • Able to understand and sign an Institution Review Board-approved informed consent form;
  • Willing and able to attend all scheduled study visits as required by the protocol;
  • Implanted with study IOLs in both eyes at least 4 months prior to study participation;
  • Best Corrected Distance Visual Acuity (BCDVA) of 0 logarithm minimum angle of resolution (logMAR) or better in each eye.

Exclusion Criteria:

  • Residual astigmatism greater than or equal to 1.00 diopter (D);
  • Clinically significant ocular conditions as specified in the protocol;
  • History of ocular surgeries other than limbal relaxing incisions
  • Other protocol-specified 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 IOLs, with previous implantation defined as at least 4 months prior to study participation.
Device: Clareon Vivity 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:
  • Clareon Vivity™ Extended Vision Hydrophobic IOL
  • Models CNWET0, CNWET3, CNWET4, CNWET5, CNWET6, CNAET0, CNAET3, CNAET4, CNAET5, CNAET6, CCWET0, CCWET3, CCWET4, CCWET5, CCWET6, CCAET0, CCAET3, CCAET4, CCAET5, CCAET6.
  • Clareon Vivity™ Extended Vision Hydrophobic Toric IOL
  • Clareon Vivity™ UV Absorbing 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 Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - WTR
Time Frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
BCDVA was assessed with best refractive correction in place at a distance of 4 meters (m) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. Trial lenses were used to induce 1.0 diopter (D) of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Day 0 before induced astigmatism; Day 0 after induced astigmatism
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism - WTR
Time Frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 centimeters (cm) from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Day 0 before induced astigmatism; Day 0 after induced astigmatism
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - WTR
Time Frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism WTR, defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis.VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Day 0 before induced astigmatism; Day 0 after induced astigmatism
Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - ATR
Time Frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
BCDVA was assessed with best refractive correction in place at a distance of 4 m using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism against the rule (ATR), defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Day 0 before induced astigmatism; Day 0 after induced astigmatism
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism.- ATR
Time Frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Day 0 before induced astigmatism; Day 0 after induced astigmatism
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - ATR
Time Frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Day 0 before induced astigmatism; Day 0 after induced astigmatism

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
April 10, 2025

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.
June 13, 2025

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.
June 13, 2025

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).
January 15, 2025

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.
January 15, 2025

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.
January 20, 2025

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.
July 13, 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.
July 10, 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.
July 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-C003

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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