Trial Outcomes & Findings for Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens (NCT NCT05518539)
NCT ID: NCT05518539
Last Updated: 2025-07-18
Results Overview
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
1 month postoperatively
Results posted on
2025-07-18
Participant Flow
Participant milestones
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
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|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
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|---|---|
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Overall Study
Lost to Follow-up
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
n=30 Participants
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
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|---|---|
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Age, Continuous
|
65.0 years
STANDARD_DEVIATION 7.7 • n=30 Participants
|
|
Sex: Female, Male
Female
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20 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 1 month postoperativelyOutcome measures
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
n=24 Participants
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
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|---|---|
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Binocular Distance-corrected Near (40 cm) Visual Acuity
|
0.00 logMAR
Standard Deviation 00.06
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PRIMARY outcome
Timeframe: 3 months postoperativelyOutcome measures
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
n=24 Participants
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
|
|---|---|
|
Binocular Distance-corrected Near (40 cm) Visual Acuity
|
0.01 logMAR
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: 1 and 3 months postoperativeOutcome measures
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
n=24 Participants
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
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|---|---|
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Binocular Uncorrected Distance (6 m) Visual Acuity
1 Month
|
0.00 logMAR
Standard Deviation 0.08
|
|
Binocular Uncorrected Distance (6 m) Visual Acuity
3 Months
|
0.02 logMAR
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: 1 and 3 months postoperativeOutcome measures
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
n=24 Participants
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
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|---|---|
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Binocular Uncorrected Intermediate (60 cm) Visual Acuity
1 Month
|
-0.04 logMAR
Standard Deviation 0.08
|
|
Binocular Uncorrected Intermediate (60 cm) Visual Acuity
3 Months
|
-0.08 logMAR
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: 1 and 3 months postoperativeOutcome measures
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
n=24 Participants
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
|
|---|---|
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Binocular Uncorrected Near (40 cm) Visual Acuity
1 Month
|
0.04 logMAR
Standard Deviation 0.09
|
|
Binocular Uncorrected Near (40 cm) Visual Acuity
3 Months
|
0.04 logMAR
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: 1 and 3 months postoperativeOutcome measures
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
n=24 Participants
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
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|---|---|
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Binocular Corrected Corrected Distance (6 m) Visual Acuity
1 Month
|
-0.02 logMAR
Standard Deviation 0.07
|
|
Binocular Corrected Corrected Distance (6 m) Visual Acuity
3 Months
|
-0.04 logMAR
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: 1 and 3 months postoperativeOutcome measures
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
n=24 Participants
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
|
|---|---|
|
Binocular Distance-corrected Intermediate (60 cm) Visual Acuity
1 Month
|
-0.04 logMAR
Standard Deviation 0.08
|
|
Binocular Distance-corrected Intermediate (60 cm) Visual Acuity
3 Months
|
-0.08 logMAR
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: 3 months postoperativespherical equivalent refraction and astigmatism less than or equal to 0.5 D.
Outcome measures
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
n=48 eyes
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
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|---|---|
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Manifest Refraction
Manifest Refraction Spherical Equivalent
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46 eyes
|
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Manifest Refraction
Astigmatism
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46 eyes
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SECONDARY outcome
Timeframe: 3 months postoperativeThe Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome.
Outcome measures
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
n=24 Participants
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
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|---|---|
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Satisfaction Questionnaire
Spectacle independence distance (overall)
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24 Participants
|
|
Satisfaction Questionnaire
Spectacle independence intermediate (overall)
|
22 Participants
|
|
Satisfaction Questionnaire
Spectacle independence near (overall)
|
17 Participants
|
SECONDARY outcome
Timeframe: 3 months postoperativeQuestionnaire for Visual Disturbances (QUVID).
Outcome measures
| Measure |
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
n=24 Participants
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
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|---|---|
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Visual Disturbances Questionnaire
Bothered quite a bit" or "Bothered very much" by starbursts
|
3 Participants
|
|
Visual Disturbances Questionnaire
Bothered quite a bit" or "Bothered very much" by halos
|
2 Participants
|
|
Visual Disturbances Questionnaire
Bothered quite a bit" or "Bothered very much" by glare
|
0 Participants
|
|
Visual Disturbances Questionnaire
Bothered quite a bit" or "Bothered very much" by haze
|
0 Participants
|
|
Visual Disturbances Questionnaire
Bothered quite a bit" or "Bothered very much" by blurred vision
|
0 Participants
|
|
Visual Disturbances Questionnaire
Bothered quite a bit" or "Bothered very much" by double vision
|
0 Participants
|
|
Visual Disturbances Questionnaire
dark area
|
0 Participants
|
Adverse Events
The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place