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/Clareon Vivity Toric IOLs or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits with model-specific data.

Study Overview

• Status: Completed
• Conditions: Aphakia
• Intervention / Treatment: Device: Clareon Vivity/Vivity Toric Extended Vision IOL; Device: Clareon/Clareon Toric Aspheric 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). 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.
  • Minnesota
    • Stillwater, Minnesota, United States, 55082
      • Associated Eye Care
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists
  • 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:

• Previous bilateral implantation of 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 Extended Vision; Previous implantation, defined as 90-180 days post second eye implantation, with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens)	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
Active Comparator: Clareon/Clareon Toric Aspheric; Previous implantation, defined as 90-180 days post second eye implantation, with Clareon/Clareon Toric Aspheric IOL (intraocular lens)	Device: Clareon/Clareon Toric Aspheric IOL; Ultraviolet-absorbing and blue light-filtering 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Binocular photopic BCDVA (logMAR) at 4 m	Visual acuity (VA) will be assessed for both eyes together with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters (m) using a visual acuity chart. The subject must be 90-180 days post 2nd eye implantation at time of assessment (Visit 1).	Visit 1 (Day 1-14)
Mean Binocular photopic DCIVA (logMAR) at 66 cm	Visual acuity (VA) will be assessed for both eyes together with best refractive correction in place under photopic (well-lit) conditions at a distance of 66 centimeters (cm) using a visual acuity chart. The subject must be 90-180 days post 2nd eye implantation at time of assessment (Visit 1).	Visit 1 (Day 1-14)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Binocular photopic DCNVA (logMAR) at 40 cm	Visual acuity (VA) will be assessed for both eyes together with distance correction (plus or minus power) in place under photopic (well-lit) conditions at a distance of 40 centimeters (cm) using a visual acuity chart. The subject must be 90-180 days post 2nd eye implantation at time of assessment (Visit 1).	Visit 1 (Day 1-14)
Proportion of subjects who respond "Never" to Question 1 of the spectacle use questionnaire (IOLSAT)	The IOLSAT is a patient-reported outcomes questionnaire. Subjects will be asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" will be reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.The subject must be 90-180 days post 2nd eye implant at the time of Visit 1.	Visit 1 (Day 1-14)

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): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cataract; Intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; 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