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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
155
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.
Single 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.
Wolstan Goldberg Eye Associates
Torrance, California, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, United States
Grosinger, Spigelman & Grey Eye Surgeons, P.C.
Bloomfield Hills, Michigan, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
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.
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
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.
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
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.
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
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Eye Care Specialists
Kingston, Pennsylvania, United States
Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
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
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.
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)