An interventional study of Clareon Vivity/Vivity Toric Extended Vision IOL and Clareon Monofocal/Clareon Toric IOL in Aphakia, sponsored by Alcon Research. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 155 is above the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
Device: Clareon Vivity/Vivity Toric Extended Vision IOL
Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
Device: Clareon Monofocal/Clareon Toric 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.
Also known as: Models CNWET0, CNWET3, CNWET4, CNWET5, CNWET6, CCWET0, CCWET3, CCWET4, CCWET5, CCWET6, Clareon Vivity™ Extended Vision Hydrophobic IOL, Clareon Vivity™ Toric Extended Vision Hydrophobic IOL
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.
Also known as: SY60WF, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, Clareon with AutonoMe (CCA0T0, CNA0T0), Clareon™ Aspheric Hydrophobic Acrylic IOL, Clareon™ Toric Aspheric Hydrophobic Acrylic IOL
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)
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)
Participants were enrolled at 7 investigative sites located in the United States.
| Milestone | Clareon Vivity/Vivity Toric | Clareon Monofocal/Clareon Toric |
|---|---|---|
| Started | 73 | 77 |
| Full analysis set | 73 | 76 |
| Completed | 73 | 76 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| logMAR | Clareon Vivity/Vivity Toric | Clareon Monofocal/Clareon Toric |
|---|---|---|
| Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | -0.028 ± 0.1165 | -0.062 ± 0.0847 |
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.
| logMAR | Clareon Vivity/Vivity Toric | Clareon Monofocal/Clareon Toric |
|---|---|---|
| Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | 0.035 ± 0.0788 | 0.126 ± 0.1033 |
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.
| logMAR | Clareon Vivity/Vivity Toric | Clareon Monofocal/Clareon Toric |
|---|---|---|
| Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | 0.205 ± 0.1008 | 0.334 ± 0.1410 |
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.
| percentage of participants | Clareon Vivity/Vivity Toric | Clareon Monofocal/Clareon Toric |
|---|---|---|
| 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 | 21.4 | 4.1 |
Collected over Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 14 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clareon Vivity/Vivity Toric - First Eye (Ocular) | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
| Clareon Vivity/Vivity Toric - Second Eye (Ocular) | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
| Clareon Vivity/Vivity Toric - Systemic | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
| Clareon Monofocal/Clareon Toric - First Eye (Ocular) | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| Clareon Monofocal/Clareon Toric - Second Eye (Ocular) | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| Clareon Monofocal/Clareon Toric - Systemic (Subject) | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
Full Analysis Set (FAS): All subjects/eyes bilaterally implanted with the test or comparator IOL
| Age, Continuous(years) | Clareon Vivity/Vivity Toric | Clareon Monofocal/Clareon Toric | Total |
|---|---|---|---|
| Mean | 68.4 ± 8.92 | 71.5 ± 6.97 | 70.0 ± 8.10 |
| Sex: Female, Male(Participants) | Clareon Vivity/Vivity Toric | Clareon Monofocal/Clareon Toric | Total |
|---|---|---|---|
| Female | 42 | 46 | 88 |
| Male | 31 | 30 | 61 |
| Ethnicity (NIH/OMB)(Participants) | Clareon Vivity/Vivity Toric | Clareon Monofocal/Clareon Toric | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 73 | 75 | 148 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Clareon Vivity/Vivity Toric | Clareon Monofocal/Clareon Toric | Total |
|---|---|---|---|
| White | 68 | 63 | 131 |
| Black or African American | 2 | 7 | 9 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 6 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Other | 0 | 0 | 0 |
| Region of Enrollment(participants) | Clareon Vivity/Vivity Toric | Clareon Monofocal/Clareon Toric | Total |
|---|---|---|---|
| United States | 73 | 76 | 149 |
PDFs hosted by the registry, ClinicalTrials.gov.
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