Trial Outcomes & Findings for Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs) (NCT NCT06784063)
NCT ID: NCT06784063
Last Updated: 2026-07-13
Results Overview
BCDVA was assessed with best refractive correction in place at a distance of 4 meters (m) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. Trial lenses were used to induce 1.0 diopter (D) of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
COMPLETED
NA
40 participants
Day 0 before induced astigmatism; Day 0 after induced astigmatism
2026-07-13
Participant Flow
Participants were recruited from 3 investigative sites.
Of the 40 participants who signed an Informed Consent, 6 were exited as screen failures. This reporting group includes all eligible subjects (34).
Participant milestones
| Measure |
Started With ATR
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with ATR induced astigmatism assessed first
|
Started With WTR
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with WTR induced astigmatism assessed first
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
20
|
|
Overall Study
COMPLETED
|
12
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs)
Baseline characteristics by cohort
| Measure |
Clareon Vivity/Vivity Toric
n=31 Participants
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation.
|
|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 8.76 • n=20 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Day 0 before induced astigmatism; Day 0 after induced astigmatismPopulation: Full Analysis Set: All enrolled subjects who met the study eligibility criteria. Note: 3 eligible subjects were randomized in error and were excluded from the Full Analysis Set.
BCDVA was assessed with best refractive correction in place at a distance of 4 meters (m) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. Trial lenses were used to induce 1.0 diopter (D) of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Outcome measures
| Measure |
Clareon Vivity/Vivity Toric
n=31 eye
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation.
|
|---|---|
|
Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - WTR
|
0.175 logMAR
Standard Deviation 0.1121
|
PRIMARY outcome
Timeframe: Day 0 before induced astigmatism; Day 0 after induced astigmatismPopulation: Full Analysis Set: All enrolled subjects who met the study eligibility criteria. Note: 3 eligible subjects were randomized in error and were excluded from the Full Analysis Set.
DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 centimeters (cm) from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Outcome measures
| Measure |
Clareon Vivity/Vivity Toric
n=31 eye
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation.
|
|---|---|
|
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism - WTR
|
0.074 logMAR
Standard Deviation 0.1141
|
PRIMARY outcome
Timeframe: Day 0 before induced astigmatism; Day 0 after induced astigmatismPopulation: Full Analysis Set: All enrolled subjects who met the study eligibility criteria. Note: 3 eligible subjects were randomized in error and were excluded from the Full Analysis Set.
DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism WTR, defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis.VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Outcome measures
| Measure |
Clareon Vivity/Vivity Toric
n=31 eye
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation.
|
|---|---|
|
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - WTR
|
0.052 logMAR
Standard Deviation 0.1425
|
PRIMARY outcome
Timeframe: Day 0 before induced astigmatism; Day 0 after induced astigmatismPopulation: Full Analysis Set: All enrolled subjects who met the study eligibility criteria. Note: 3 eligible subjects were randomized in error and were excluded from the Full Analysis Set.
BCDVA was assessed with best refractive correction in place at a distance of 4 m using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism against the rule (ATR), defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Outcome measures
| Measure |
Clareon Vivity/Vivity Toric
n=31 eye
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation.
|
|---|---|
|
Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - ATR
|
0.184 logMAR
Standard Deviation 0.1321
|
PRIMARY outcome
Timeframe: Day 0 before induced astigmatism; Day 0 after induced astigmatismPopulation: Full Analysis Set: All enrolled subjects who met the study eligibility criteria. Note: 3 eligible subjects were randomized in error and were excluded from the Full Analysis Set.
DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Outcome measures
| Measure |
Clareon Vivity/Vivity Toric
n=31 eye
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation.
|
|---|---|
|
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism.- ATR
|
0.060 logMAR
Standard Deviation 0.0996
|
PRIMARY outcome
Timeframe: Day 0 before induced astigmatism; Day 0 after induced astigmatismPopulation: Full Analysis Set: All enrolled subjects who met the study eligibility criteria. Note: 3 eligible subjects were randomized in error and were excluded from the Full Analysis Set.
DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Outcome measures
| Measure |
Clareon Vivity/Vivity Toric
n=31 eye
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation.
|
|---|---|
|
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - ATR
|
0.023 logMAR
Standard Deviation 0.1077
|
Adverse Events
Clareon Vivity/Vivity Toric
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER