Trial Outcomes & Findings for Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance With Clareon® Vivity® IOL Implantation (NCT NCT05827133)
NCT ID: NCT05827133
Last Updated: 2026-07-10
Results Overview
The mean value and standard deviation of IOL decentration.
Recruitment status
COMPLETED
Target enrollment
101 participants
Primary outcome timeframe
1 day
Results posted on
2026-07-10
Participant Flow
Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs).
Unit of analysis: Eyes
Participant milestones
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|---|---|
|
Overall Study
STARTED
|
101 202
|
|
Overall Study
COMPLETED
|
101 202
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age of Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
Baseline characteristics by cohort
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 6 • n=9 Participants • Age of Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Sex: Female, Male
Female
|
56 Participants
n=9 Participants • Sex of Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Sex: Female, Male
Male
|
45 Participants
n=9 Participants • Sex of Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants • Race for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants • Race for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • Race for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants • Race for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Race (NIH/OMB)
White
|
100 Participants
n=9 Participants • Race for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants • Race for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • Race for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=9 Participants • Ethnicity for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=9 Participants • Ethnicity for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants • Ethnicity for IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
IOL Type
Non-toric
|
70 Participants
n=9 Participants • IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
IOL Type
Toric
|
31 Participants
n=9 Participants • IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Pre-Op CDVA High-Contrast
|
0.177 logMAR
STANDARD_DEVIATION 0.166 • n=9 Participants • Pre-operation Data High-Contrast CDVA in IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
|
Pre-Op MRSE
|
-0.031 D
STANDARD_DEVIATION 2.801 • n=9 Participants • Pre-operation Data MRSE in IOL Types for Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
|
PRIMARY outcome
Timeframe: 1 DayPopulation: All participants enrolled were analyzed.
The mean between Monocular best-corrected distance visual acuity (CDVA100) (logMAR) (High Contrast - 100%).
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=101 Participants
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
CDVA100
|
0.056 logMAR
Standard Deviation 0.110
|
PRIMARY outcome
Timeframe: 1 dayPopulation: All participants enrolled were analyzed.
The mean value and standard deviation of IOL decentration.
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
IOL Decentration
|
0.211 mm
Standard Deviation 0.127
|
PRIMARY outcome
Timeframe: 1 dayPopulation: All participants enrolled were analyzed.
The mean value and standard deviation of IOL tilt.
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
IOL Tilt
|
5.6 degree
Standard Deviation 1.178
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All participants enrolled were analyzed.
The mean between Uncorrected Distance Visual Acuity (UCDVA100) (logMAR) (High Contrast - 100%)
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
UCDVA100
|
0.155 logMAR
Standard Deviation 0.143
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All participants enrolled were analyzed.
The mean between Uncorrected Intermediate Visual Acuity (UCIVA100) (logMAR) (High Contrast - 100%).
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
UCIVA100
|
0.019 logMAR
Standard Deviation 0.100
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All participants were analyzed.
The mean between Distance Corrected Intermediate Visual Acuity (100%) (DCIVA100) (logMAR) (High Contrast - 100%).
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
DCIVA100
|
0.018 logMAR
Standard Deviation 0.068
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All participants enrolled were analyzed.
The mean between Manifest Refraction Spherical Equivalent (MRSE) (D).
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
MRSE
|
-0.146 D
Standard Deviation 0.443
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayPopulation: All participants enrolled were analyzed.
The mean between Corrected Distant Visual Acuity (logMAR) (Low Contrast - 25%).
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
CDVA25
|
0.171 logMAR
Standard Deviation 0.119
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayPopulation: All participants enrolled were analyzed.
The mean between Mesopic Pupil Size (mm).
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
Mesopic Pupil Size
|
2.980 mm
Standard Deviation 0.785
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayPopulation: All participants enrolled were analyzed.
The mean between Higher-Order Aberration, Spherical (HOA S) (µm)
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
HOA S
|
0.011 µm
Standard Deviation 0.012
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayPopulation: All participants enrolled were analyzed.
The mean between Higher-Order Aberration- Coma, Horizontal (HOA CH).
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
HOA CH
|
0.007 µm
Standard Deviation 0.026
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayPopulation: All participants enrolled were analyzed.
The mean between Higher-Order Aberration- Coma, Vertical (HOA CV) (µm).
Outcome measures
| Measure |
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
n=202 Eyes
Individuals who have a history of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric IOL implantation with MRSE within ±1.00 D.
|
|---|---|
|
HOA CV
|
0.011 µm
Standard Deviation 0.069
|
Adverse Events
Individuals Implanted With Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rebecca Goldfaden, PharmD, CCRP
East Coast Institute for Research at Florida Eye Specialists
Phone: 904-854-1354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place