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Evaluation of Clareon Vivity/Vivity Toric

Sponsor
Alcon Research (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05852470
Collaborator
(none)
210
Enrollment
7
Locations
2
Arms
5
Anticipated Duration (Months)
30
Patients Per Site
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Clareon Vivity/Vivity Toric Extended Vision IOL
  • Device: Clareon/Clareon Toric Aspheric IOL
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Assessors will be masked to the IOLs that have been previously implanted in the subject until the end of the study.
Primary Purpose:
Treatment
Official Title:
PMCF (Post Market Clinical Follow-up) Evaluation of Clareon Vivity/Vivity Toric
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean Binocular photopic BCDVA (logMAR) at 4 m [Visit 1 (Day 1-14)]

      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).

    2. Mean Binocular photopic DCIVA (logMAR) at 66 cm [Visit 1 (Day 1-14)]

      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).

    Secondary Outcome Measures

    1. Mean Binocular photopic DCNVA (logMAR) at 40 cm [Visit 1 (Day 1-14)]

      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).

    2. Proportion of subjects who respond "Never" to Question 1 of the spectacle use questionnaire (IOLSAT) [Visit 1 (Day 1-14)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wolstan Goldberg Eye Associates Torrance California United States 90505
    2 Eye Center of Northern Colorado, PC Fort Collins Colorado United States 80528
    3 Grosinger, Spigelman & Grey Eye Surgeons, P.C. Bloomfield Hills Michigan United States 48302
    4 Associated Eye Care Stillwater Minnesota United States 55082
    5 Cincinnati Eye Institute Cincinnati Ohio United States 45242
    6 Eye Care Specialists Kingston Pennsylvania United States 18704
    7 Vance Thompson Vision Sioux Falls South Dakota United States 57108

    Sponsors and Collaborators

    • Alcon Research

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT05852470
    Other Study ID Numbers:
    • ILE632-C002
    First Posted:
    May 10, 2023
    Last Update Posted:
    May 10, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Alcon Research
    Cataract
    Intraocular lens
    Additional relevant MeSH terms:
    Aphakia

    Study Results

    No Results Posted as of May 10, 2023