Evaluation of Clareon Vivity/Vivity Toric

Not Applicable

Completed

Interventions: Device: Clareon Vivity/Vivity Toric Extended Vision IOL
Device: Clareon/Clareon Toric Aspheric IOL

Brief Summary: 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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Clareon Vivity/Vivity Toric Extended Vision	Clareon Vivity/Vivity Toric Extended Vision IOL	Previous implantation, defined as 90-180 days post second eye implantation, with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens)
Clareon/Clareon Toric Aspheric	Clareon/Clareon Toric Aspheric IOL	Previous implantation, defined as 90-180 days post second eye implantation, with Clareon/Clareon Toric Aspheric IOL (intraocular lens)

Primary Outcome Measures

Name	Time	Method
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant	Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)	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.
Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant	Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)	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.

Secondary Outcome Measures

Name	Time	Method
Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant	Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)	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.
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	Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)	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.

Locations (7): Wolstan Goldberg Eye Associates
🇺🇸
Torrance, California, United States
Eye Center of Northern Colorado, PC
🇺🇸
Fort Collins, Colorado, United States
Carolina Eyecare Physicians LLC
🇺🇸
Mount Pleasant, South Carolina, United States
Grosinger, Spigelman & Grey Eye Surgeons, P.C.
🇺🇸
Bloomfield Hills, Michigan, United States
Cincinnati Eye Institute
🇺🇸
Cincinnati, Ohio, United States
Eye Care Specialists
🇺🇸
Kingston, Pennsylvania, United States
Vance Thompson Vision
🇺🇸
Sioux Falls, South Dakota, United States