Trial Outcomes & Findings for Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens (NCT NCT06122103)
NCT ID: NCT06122103
Last Updated: 2026-01-28
Results Overview
Recruitment status
COMPLETED
Target enrollment
138 participants
Primary outcome timeframe
3 months postop
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
Clareon Monofocal
Bilateral Implantation of the Clareon Monofocal IOL
|
Light-Adjustable Lens
Bilateral Implantation of the Light-Adjustable Lens
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
68
|
|
Overall Study
COMPLETED
|
70
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Clareon Monofocal
n=70 Participants
Bilateral Implantation of the Clareon Monofocal IOL
|
Light-Adjustable Lens
n=68 Participants
Bilateral Implantation of the Light-Adjustable Lens
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.7 Years
STANDARD_DEVIATION 7.9 • n=70 Participants
|
70.8 Years
STANDARD_DEVIATION 7.6 • n=68 Participants
|
71.2 Years
STANDARD_DEVIATION 7.6 • n=138 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=70 Participants
|
38 Participants
n=68 Participants
|
83 Participants
n=138 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=70 Participants
|
30 Participants
n=68 Participants
|
55 Participants
n=138 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 3 months postopOutcome measures
| Measure |
Light-Adjustable Lens
n=68 Participants
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=70 Participants
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Binocular Corrected Distance Visual Acuity (CDVA)
|
-0.03 logMAR
Standard Deviation 0.07
|
-0.03 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 3 months postopOutcome measures
| Measure |
Light-Adjustable Lens
n=68 Participants
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=70 Participants
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Binocular Uncorrected Distance Visual Acuity (UDVA)
|
0.03 logMAR
Standard Deviation 0.10
|
0.02 logMAR
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: 3 months postopOutcome measures
| Measure |
Light-Adjustable Lens
n=68 Participants
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=70 Participants
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
|
0.11 logMAR
Standard Deviation 0.11
|
0.17 logMAR
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: 3 months postopOutcome measures
| Measure |
Light-Adjustable Lens
n=68 Participants
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=70 Participants
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Binocular Uncorrected Intermediate Visual Acuity (UIVA)
|
0.04 logMAR
Standard Deviation 0.09
|
0.06 logMAR
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: 3 months postopOutcome measures
| Measure |
Light-Adjustable Lens
n=136 eyes
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=140 eyes
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Monocular Corrected Distance Visual Acuity (CDVA)
Dominant Eyes
|
0.01 logMAR
Standard Deviation 0.08
|
-0.01 logMAR
Standard Deviation 0.07
|
|
Monocular Corrected Distance Visual Acuity (CDVA)
Non-Dominant Eyes
|
0.01 logMAR
Standard Deviation 0.07
|
0.02 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 3 months postopOutcome measures
| Measure |
Light-Adjustable Lens
n=136 eyes
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=140 eyes
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Monocular Uncorrected Distance Visual Acuity (UDVA)
Dominant Eyes
|
0.08 logMAR
Standard Deviation 0.12
|
0.05 logMAR
Standard Deviation 0.10
|
|
Monocular Uncorrected Distance Visual Acuity (UDVA)
Non-Dominant Eyes
|
0.26 logMAR
Standard Deviation 0.18
|
0.28 logMAR
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: 3 months postopOutcome measures
| Measure |
Light-Adjustable Lens
n=136 eyes
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=140 eyes
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Dominant Eyes
|
0.23 logMAR
Standard Deviation 0.14
|
0.26 logMAR
Standard Deviation 0.12
|
|
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Non-Dominant Eyes
|
0.22 logMAR
Standard Deviation 0.13
|
0.25 logMAR
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: 3 months postopOutcome measures
| Measure |
Light-Adjustable Lens
n=136 eyes
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=140 eyes
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Dominant Eyes
|
0.22 logMAR
Standard Deviation 0.16
|
0.30 logMAR
Standard Deviation 0.18
|
|
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Non-Dominant Eyes
|
0.08 logMAR
Standard Deviation 0.12
|
0.11 logMAR
Standard Deviation 0.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months postopOutcome measures
| Measure |
Light-Adjustable Lens
n=68 Participants
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=70 Participants
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Binocular Distance-corrected Near Visual Acuity (DCNVA)
|
0.34 logMAR
Standard Deviation 0.16
|
0.38 logMAR
Standard Deviation 0.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months postopOutcome measures
| Measure |
Light-Adjustable Lens
n=68 Participants
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=70 Participants
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Binocular Uncorrected Near Visual Acuity (UNVA)
|
0.18 logMAR
Standard Deviation 0.11
|
0.25 logMAR
Standard Deviation 0.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months postopPopulation: Data were collected for Dominant and Non-Dominant Eyes for the LAL Group and Dominant Eyes for the Clareon Group
Outcome measures
| Measure |
Light-Adjustable Lens
n=136 eyes
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=140 eyes
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Monocular Distance Corrected Defocus Curve
1.00 D (Dominant Eyes)
|
0.24 logMAR
Standard Deviation 0.18
|
0.28 logMAR
Standard Deviation 0.16
|
|
Monocular Distance Corrected Defocus Curve
1.00 D (Non-Dominant Eyes)
|
0.30 logMAR
Standard Deviation 0.23
|
—
|
|
Monocular Distance Corrected Defocus Curve
0.50 D (Dominant Eyes)
|
0.14 logMAR
Standard Deviation 0.20
|
0.12 logMAR
Standard Deviation 0.13
|
|
Monocular Distance Corrected Defocus Curve
0.50 D (Non-Dominant Eyes)
|
0.18 logMAR
Standard Deviation 0.22
|
—
|
|
Monocular Distance Corrected Defocus Curve
0.25 D (Dominant Eyes)
|
0.10 logMAR
Standard Deviation 0.14
|
0.07 logMAR
Standard Deviation 0.12
|
|
Monocular Distance Corrected Defocus Curve
0.25 D (Non-Dominant Eyes)
|
0.14 logMAR
Standard Deviation 0.14
|
—
|
|
Monocular Distance Corrected Defocus Curve
0.00 D (Dominant Eyes)
|
0.05 logMAR
Standard Deviation 0.12
|
0.03 logMAR
Standard Deviation 0.10
|
|
Monocular Distance Corrected Defocus Curve
0.00 D (Non-Dominant Eyes)
|
0.10 logMAR
Standard Deviation 0.22
|
—
|
|
Monocular Distance Corrected Defocus Curve
-0.25 D (Dominant Eyes)
|
0.07 logMAR
Standard Deviation 0.10
|
0.07 logMAR
Standard Deviation 0.12
|
|
Monocular Distance Corrected Defocus Curve
-0.25 D (Non-Dominant Eyes)
|
0.11 logMAR
Standard Deviation 0.20
|
—
|
|
Monocular Distance Corrected Defocus Curve
-0.50 D (Dominant Eyes)
|
0.10 logMAR
Standard Deviation 0.12
|
0.10 logMAR
Standard Deviation 0.12
|
|
Monocular Distance Corrected Defocus Curve
-0.50 D (Non-Dominant Eyes)
|
0.13 logMAR
Standard Deviation 0.19
|
—
|
|
Monocular Distance Corrected Defocus Curve
-1.00 D (Dominant Eyes)
|
0.16 logMAR
Standard Deviation 0.14
|
0.21 logMAR
Standard Deviation 0.13
|
|
Monocular Distance Corrected Defocus Curve
-1.00 D (Non-Dominant Eyes)
|
0.20 logMAR
Standard Deviation 0.16
|
—
|
|
Monocular Distance Corrected Defocus Curve
-1.50 D (Dominant Eyes)
|
0.30 logMAR
Standard Deviation 0.17
|
0.36 logMAR
Standard Deviation 0.16
|
|
Monocular Distance Corrected Defocus Curve
-1.50 D (Non-Dominant Eyes)
|
0.28 logMAR
Standard Deviation 0.17
|
—
|
|
Monocular Distance Corrected Defocus Curve
-2.00 D (Dominant Eyes)
|
0.43 logMAR
Standard Deviation 0.19
|
0.48 logMAR
Standard Deviation 0.18
|
|
Monocular Distance Corrected Defocus Curve
-2.00 D (Non-Dominant Eyes)
|
0.38 logMAR
Standard Deviation 0.19
|
—
|
|
Monocular Distance Corrected Defocus Curve
-2.50 D (Dominant Eyes)
|
0.58 logMAR
Standard Deviation 0.21
|
0.61 logMAR
Standard Deviation 0.19
|
|
Monocular Distance Corrected Defocus Curve
-2.50 D (Non-Dominant Eyes)
|
0.50 logMAR
Standard Deviation 0.23
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months postopOutcome measures
| Measure |
Light-Adjustable Lens
n=68 Participants
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=70 Participants
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Binocular Distance Corrected Defocus Curve
1.00 D
|
0.22 logMAR
Standard Deviation 0.17
|
0.25 logMAR
Standard Deviation 0.14
|
|
Binocular Distance Corrected Defocus Curve
0.50 D
|
0.11 logMAR
Standard Deviation 0.12
|
0.08 logMAR
Standard Deviation 0.11
|
|
Binocular Distance Corrected Defocus Curve
0.25 D
|
0.07 logMAR
Standard Deviation 0.11
|
0.04 logMAR
Standard Deviation 0.09
|
|
Binocular Distance Corrected Defocus Curve
0.00 D
|
0.03 logMAR
Standard Deviation 0.09
|
0.00 logMAR
Standard Deviation 0.08
|
|
Binocular Distance Corrected Defocus Curve
-0.25 D
|
0.03 logMAR
Standard Deviation 0.09
|
0.03 logMAR
Standard Deviation 0.12
|
|
Binocular Distance Corrected Defocus Curve
-0.50 D
|
0.04 logMAR
Standard Deviation 0.09
|
0.05 logMAR
Standard Deviation 0.09
|
|
Binocular Distance Corrected Defocus Curve
-1.00 D
|
0.08 logMAR
Standard Deviation 0.12
|
0.09 logMAR
Standard Deviation 0.11
|
|
Binocular Distance Corrected Defocus Curve
-1.50 D
|
0.13 logMAR
Standard Deviation 0.13
|
0.11 logMAR
Standard Deviation 0.13
|
|
Binocular Distance Corrected Defocus Curve
-2.00 D
|
0.13 logMAR
Standard Deviation 0.15
|
0.13 logMAR
Standard Deviation 0.17
|
|
Binocular Distance Corrected Defocus Curve
-2.50 D
|
0.16 logMAR
Standard Deviation 0.21
|
0.21 logMAR
Standard Deviation 0.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months postopMRSE, residual sphere, and residual astigmatism
Outcome measures
| Measure |
Light-Adjustable Lens
n=68 eyes
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=70 eyes
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Manifest Refraction
Sphere (Dominant Eyes)
|
-0.05 D
Standard Deviation 0.24
|
-0.13 D
Standard Deviation 0.31
|
|
Manifest Refraction
Sphere (Non-Dominant Eyes)
|
-1.08 D
Standard Deviation 0.32
|
-0.97 D
Standard Deviation 0.29
|
|
Manifest Refraction
Cylinder (Dominant Eyes)
|
0.07 D
Standard Deviation 0.19
|
0.06 D
Standard Deviation 0.18
|
|
Manifest Refraction
Cylinder (Non-Dominant Eyes)
|
0.11 D
Standard Deviation 0.22
|
0.06 D
Standard Deviation 0.20
|
|
Manifest Refraction
MRSE (Dominant Eyes)
|
-0.01 D
Standard Deviation 0.24
|
-0.10 D
Standard Deviation 0.30
|
|
Manifest Refraction
MRSE (Non-Dominant Eyes)
|
-1.03 D
Standard Deviation 0.37
|
-0.94 D
Standard Deviation 0.31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months postopPopulation: Count of participants answering "None of the time" when asked "During the last 7 days, how often did you need glasses or contacts"
Participants are asked to indicate spectacle usage on a scale of "All of the time" to "None of the time" for distance, intermediate, and near vision.
Outcome measures
| Measure |
Light-Adjustable Lens
n=68 Participants
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=70 Participants
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Patient Reported Spectacle Usage Questionnaire (PRSIQ)
Distance
|
91 percentage of participants
|
93 percentage of participants
|
|
Patient Reported Spectacle Usage Questionnaire (PRSIQ)
Intermediate
|
87 percentage of participants
|
79 percentage of participants
|
|
Patient Reported Spectacle Usage Questionnaire (PRSIQ)
Near
|
49 percentage of participants
|
37 percentage of participants
|
|
Patient Reported Spectacle Usage Questionnaire (PRSIQ)
Overall
|
50 percentage of participants
|
39 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months postopPopulation: 70 dominant and 70 non-dominant eyes (140 eyes total) in the Clareon Group 68 dominant and 68 non-dominant eyes (136 eyes total) in the LAL Group
Aberrometry was performed using the iTrace (Tracy Technologies, USA)
Outcome measures
| Measure |
Light-Adjustable Lens
n=136 eyes
Bilateral Implantation of the Light-Adjustable Lens
|
Clareon Monofocal
n=140 eyes
Bilateral Implantation of the Clareon Monofocal IOL
|
|---|---|---|
|
Wavefront Aberrometry Using iTrace (Internal, Ocular, and Corneal Total Higher Order Aberrations)
Ocular HOA (Dominant Eyes)
|
0.38 microns
Standard Deviation 0.21
|
0.36 microns
Standard Deviation 0.24
|
|
Wavefront Aberrometry Using iTrace (Internal, Ocular, and Corneal Total Higher Order Aberrations)
Ocular HOA (Non-Dominant Eyes)
|
0.45 microns
Standard Deviation 0.25
|
0.31 microns
Standard Deviation 0.23
|
|
Wavefront Aberrometry Using iTrace (Internal, Ocular, and Corneal Total Higher Order Aberrations)
Internal HOA (Dominant Eyes)
|
0.31 microns
Standard Deviation 0.16
|
0.25 microns
Standard Deviation 0.18
|
|
Wavefront Aberrometry Using iTrace (Internal, Ocular, and Corneal Total Higher Order Aberrations)
Internal HOA (Non-Dominant Eyes)
|
0.40 microns
Standard Deviation 0.21
|
0.25 microns
Standard Deviation 0.26
|
|
Wavefront Aberrometry Using iTrace (Internal, Ocular, and Corneal Total Higher Order Aberrations)
Corneal HOA (Dominant Eyes)
|
0.31 microns
Standard Deviation 0.20
|
0.29 microns
Standard Deviation 0.16
|
|
Wavefront Aberrometry Using iTrace (Internal, Ocular, and Corneal Total Higher Order Aberrations)
Corneal HOA (Non-Dominant Eyes)
|
0.37 microns
Standard Deviation 0.26
|
0.30 microns
Standard Deviation 0.22
|
Adverse Events
Clareon Monofocal
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Light-Adjustable Lens
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clareon Monofocal
n=70 participants at risk
Clareon Monofocal: Clareon Monofocal Intraocular Lens (toric and non-toric)
|
Light-Adjustable Lens
n=68 participants at risk
Light-Adjustable Lens: Light-Adjustable Lens (Intraocular Lens)
|
|---|---|---|
|
Eye disorders
YAG laser capsulotomy
|
5.7%
4/70 • 3 months
|
5.9%
4/68 • 3 months
|
|
Eye disorders
Dry Eye
|
2.9%
2/70 • 3 months
|
10.3%
7/68 • 3 months
|
|
Eye disorders
Herpes simplex virus keratitis
|
0.00%
0/70 • 3 months
|
2.9%
2/68 • 3 months
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/70 • 3 months
|
1.5%
1/68 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place