Back to resultsEvaluation of Clareon Vivity/Vivity Toric
Primary Purpose
Aphakia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clareon Vivity/Vivity Toric Extended Vision IOL
Clareon/Clareon Toric Aspheric IOL
Sponsored by
About this trial
This is an interventional treatment trial for Aphakia focused on measuring Cataract, Intraocular lens
Eligibility Criteria
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.
Sites / Locations
- Wolstan Goldberg Eye AssociatesRecruiting
- Eye Center of Northern Colorado, PCRecruiting
- Grosinger, Spigelman & Grey Eye Surgeons, P.C.Recruiting
- Associated Eye CareRecruiting
- Cincinnati Eye InstituteRecruiting
- Eye Care SpecialistsRecruiting
- Vance Thompson VisionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clareon Vivity/Vivity Toric Extended Vision
Clareon/Clareon Toric Aspheric
Arm Description
Previous implantation, defined as 90-180 days post second eye implantation, with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens)
Previous implantation, defined as 90-180 days post second eye implantation, with Clareon/Clareon Toric Aspheric IOL (intraocular lens)
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05852470
Brief Title
Evaluation of Clareon Vivity/Vivity Toric
Official Title
PMCF (Post Market Clinical Follow-up) Evaluation of Clareon Vivity/Vivity Toric
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
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
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia
Keywords
Cataract, Intraocular lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Non-Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clareon Vivity/Vivity Toric Extended Vision
Arm Type
Experimental
Arm Description
Previous implantation, defined as 90-180 days post second eye implantation, with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens)
Arm Title
Clareon/Clareon Toric Aspheric
Arm Type
Active Comparator
Arm Description
Previous implantation, defined as 90-180 days post second eye implantation, with Clareon/Clareon Toric Aspheric IOL (intraocular lens)
Intervention Type
Device
Intervention Name(s)
Clareon Vivity/Vivity Toric Extended Vision IOL
Other Intervention Name(s)
Models CNWET0, CNWET3, CNWET4, CNWET5, CNWET6, CCWET0, CCWET3, CCWET4, CCWET5, CCWET6
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Clareon/Clareon Toric Aspheric IOL
Other Intervention Name(s)
SY60WF, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, Clareon with AutonoMe (CCA0T0, CNA0T0)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Binocular photopic BCDVA (logMAR) at 4 m
Description
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).
Time Frame
Visit 1 (Day 1-14)
Title
Mean Binocular photopic DCIVA (logMAR) at 66 cm
Description
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).
Time Frame
Visit 1 (Day 1-14)
Secondary Outcome Measure Information:
Title
Mean Binocular photopic DCNVA (logMAR) at 40 cm
Description
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).
Time Frame
Visit 1 (Day 1-14)
Title
Proportion of subjects who respond "Never" to Question 1 of the spectacle use questionnaire (IOLSAT)
Description
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.
Time Frame
Visit 1 (Day 1-14)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alcon Call Center
Phone
1-888-451-3937
Email
alcon.medinfo@alcon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Surgical CRD
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Wolstan Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Name
Eye Center of Northern Colorado, PC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Recruiting
Facility Name
Grosinger, Spigelman & Grey Eye Surgeons, P.C.
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Individual Site Status
Recruiting
Facility Name
Associated Eye Care
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Individual Site Status
Recruiting
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Clareon Vivity/Vivity Toric
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