Evaluation of Clareon Vivity/Vivity Toric

Study Overview
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Brief Summary
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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
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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.

Official Title
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PMCF (Post Market Clinical Follow-up) Evaluation of Clareon Vivity/Vivity Toric

Conditions
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Aphakia

Intervention / Treatment
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* Device: Clareon Vivity/Vivity Toric Extended Vision IOL
* Device: Clareon/Clareon Toric Aspheric IOL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clareon Vivity/Vivity Toric Extended Vision<br>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<br>* 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.<br>* Other names: Models CNWET0, CNWET3, CNWET4, CNWET5, CNWET6, CCWET0, CCWET3, CCWET4, CCWET5, CCWET6;|
| Active Comparator: Clareon/Clareon Toric Aspheric<br>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<br>* 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.<br>* Other names: SY60WF, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, Clareon with AutonoMe (CCA0T0, CNA0T0);|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Intraocular lens