Evaluation of Clareon Vivity/Vivity Toric

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: Completed
• Conditions: Aphakia
• Intervention / Treatment: Device: Clareon Vivity/Vivity Toric Extended Vision IOL; Device: Clareon Monofocal/Clareon Toric IOL

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: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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	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

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	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	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

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Surgical CRD, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cataract; Intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Aphakia
• Other Study ID 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