Trial Outcomes & Findings for Comparing Visual Outcomes in Matched Patients Receiving a Low Cylinder Power Toric IOL or a Non-toric IOL (NCT NCT06717607)
NCT ID: NCT06717607
Last Updated: 2026-06-15
Results Overview
Uncorrected distance visual acuty in logMAR
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
3 months
Results posted on
2026-06-15
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Clareon T2 IOL Implantation
Clareon T2 (low cylinder) toric IOL implanted
|
Clareon Non-toric IOL Implantation
The Clareon aspheric (non-toric) IOL was implanted
|
|---|---|---|
|
Overall Study
STARTED
|
25 30
|
18 20
|
|
Overall Study
COMPLETED
|
25 30
|
18 20
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was considered by participant, rather than eye.
Baseline characteristics by cohort
| Measure |
Clareon T2 IOL Implantation
n=25 Participants
Clareon T2 (low cylinder) toric IOL implanted
|
Clareon Non-toric IOL Implantation
n=18 Participants
The Clareon aspheric (non-toric) IOL was implanted
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 Years
STANDARD_DEVIATION 6 • n=25 Participants • Age was considered by participant, rather than eye.
|
73 Years
STANDARD_DEVIATION 7 • n=18 Participants • Age was considered by participant, rather than eye.
|
74 Years
STANDARD_DEVIATION 7 • n=43 Participants • Age was considered by participant, rather than eye.
|
|
Sex: Female, Male
Female
|
13 Participants
n=25 Participants • Sex was considered by participant, rather than eye.
|
11 Participants
n=18 Participants • Sex was considered by participant, rather than eye.
|
24 Participants
n=43 Participants • Sex was considered by participant, rather than eye.
|
|
Sex: Female, Male
Male
|
12 Participants
n=25 Participants • Sex was considered by participant, rather than eye.
|
7 Participants
n=18 Participants • Sex was considered by participant, rather than eye.
|
19 Participants
n=43 Participants • Sex was considered by participant, rather than eye.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Norway
|
25 Participants
n=25 Participants
|
18 Participants
n=18 Participants
|
43 Participants
n=43 Participants
|
PRIMARY outcome
Timeframe: 3 monthsUncorrected distance visual acuty in logMAR
Outcome measures
| Measure |
Clareon Non-toric IOL Implantation
n=20 Eyes
The Clareon aspheric (non-toric) IOL was implanted
|
Clareon T2 IOL Implantation
n=30 Eyes
Clareon T2 (low cylinder) toric IOL implanted
|
|---|---|---|
|
UDVA
|
0.09 logMAR
Standard Deviation 0.13
|
0 logMAR
Standard Deviation .08
|
SECONDARY outcome
Timeframe: 3 monthsManifest refractive cylinder, in diopters
Outcome measures
| Measure |
Clareon Non-toric IOL Implantation
n=20 Eyes
The Clareon aspheric (non-toric) IOL was implanted
|
Clareon T2 IOL Implantation
n=30 Eyes
Clareon T2 (low cylinder) toric IOL implanted
|
|---|---|---|
|
Manifest Refractive Cylinder
|
0.59 Dioptres
Standard Deviation .28
|
0.23 Dioptres
Standard Deviation .22
|
SECONDARY outcome
Timeframe: 3 monthsthe percentage of eyes with \<= 0.25 D of postoperative refractive cylinder
Outcome measures
| Measure |
Clareon Non-toric IOL Implantation
n=20 Eyes
The Clareon aspheric (non-toric) IOL was implanted
|
Clareon T2 IOL Implantation
n=30 Eyes
Clareon T2 (low cylinder) toric IOL implanted
|
|---|---|---|
|
Percentage of Eyes With <= 0.25 D of Refractive Cylinder
|
4 Eyes
|
22 Eyes
|
SECONDARY outcome
Timeframe: 3 monthsThe percentage of eyes with \<= 0.50 D of refractive cylinder
Outcome measures
| Measure |
Clareon Non-toric IOL Implantation
n=20 Eyes
The Clareon aspheric (non-toric) IOL was implanted
|
Clareon T2 IOL Implantation
n=30 Eyes
Clareon T2 (low cylinder) toric IOL implanted
|
|---|---|---|
|
Percentage of Eyes With <= 0.50 D of Refractive Cylinder
|
11 Eyes
|
29 Eyes
|
SECONDARY outcome
Timeframe: 3 monthsCorrected distance visual acuity (CDVA), logMAR
Outcome measures
| Measure |
Clareon Non-toric IOL Implantation
n=20 Eyes
The Clareon aspheric (non-toric) IOL was implanted
|
Clareon T2 IOL Implantation
n=30 Eyes
Clareon T2 (low cylinder) toric IOL implanted
|
|---|---|---|
|
Corrected Distance Visual Acuity
|
-0.04 logMAR
Standard Deviation .07
|
-0.07 logMAR
Standard Deviation .05
|
SECONDARY outcome
Timeframe: 3 monthsMesopic log contrast sensitivity by spatial frequency - cycles per degree (CPD), using the Clinical Trial Suite (CTS) from M\&S Technologies (Niles, IL, 129 USA)
Outcome measures
| Measure |
Clareon Non-toric IOL Implantation
n=20 Eyes
The Clareon aspheric (non-toric) IOL was implanted
|
Clareon T2 IOL Implantation
n=30 Eyes
Clareon T2 (low cylinder) toric IOL implanted
|
|---|---|---|
|
Mesopic Contrast Sensitivity
12 CPD
|
-0.25 log contrast sensitivity
Standard Deviation 0.63
|
-0.23 log contrast sensitivity
Standard Deviation 0.57
|
|
Mesopic Contrast Sensitivity
6 CPD
|
-1.17 log contrast sensitivity
Standard Deviation 0.33
|
-1.21 log contrast sensitivity
Standard Deviation 0.25
|
|
Mesopic Contrast Sensitivity
3 CPD
|
-1.72 log contrast sensitivity
Standard Deviation 0.30
|
-1.76 log contrast sensitivity
Standard Deviation 0.24
|
|
Mesopic Contrast Sensitivity
1.5 CPD
|
-1.69 log contrast sensitivity
Standard Deviation 0.29
|
-1.79 log contrast sensitivity
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: 3 monthsPhotopic log contrast sensitivity by spatial frequency - cycles per degree (CPD), using the Clinical Trial Suite (CTS) from M\&S Technologies (Niles, IL, 129 USA)
Outcome measures
| Measure |
Clareon Non-toric IOL Implantation
n=20 Eyes
The Clareon aspheric (non-toric) IOL was implanted
|
Clareon T2 IOL Implantation
n=30 Eyes
Clareon T2 (low cylinder) toric IOL implanted
|
|---|---|---|
|
Photopic Contrast Sensitivity
18 CPD
|
-0.08 log contrast sensitivity
Standard Deviation 0.78
|
0.06 log contrast sensitivity
Standard Deviation 0.67
|
|
Photopic Contrast Sensitivity
12 CPD
|
-0.82 log contrast sensitivity
Standard Deviation 0.67
|
-0.84 log contrast sensitivity
Standard Deviation 0.60
|
|
Photopic Contrast Sensitivity
6 CPD
|
-1.70 log contrast sensitivity
Standard Deviation 0.40
|
-1.82 log contrast sensitivity
Standard Deviation 0.32
|
|
Photopic Contrast Sensitivity
3 CPD
|
-1.68 log contrast sensitivity
Standard Deviation 0.29
|
-2.16 log contrast sensitivity
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: 3 monthsLow contrast visual acuity (VA), logMAR, 10% contrast, using the Clinical Trial Suite (CTS) from M\&S Technologies (Niles, IL, 129 USA)
Outcome measures
| Measure |
Clareon Non-toric IOL Implantation
n=20 Eyes
The Clareon aspheric (non-toric) IOL was implanted
|
Clareon T2 IOL Implantation
n=30 Eyes
Clareon T2 (low cylinder) toric IOL implanted
|
|---|---|---|
|
Low Contrast Visual Acuity
Mesopic no glare
|
0.62 logMAR
Standard Deviation 0.2
|
0.59 logMAR
Standard Deviation 0.2
|
|
Low Contrast Visual Acuity
Photopic no glare
|
.34 logMAR
Standard Deviation .14
|
.33 logMAR
Standard Deviation .15
|
|
Low Contrast Visual Acuity
Photopic glare
|
1.09 logMAR
Standard Deviation .03
|
1.06 logMAR
Standard Deviation .09
|
|
Low Contrast Visual Acuity
Mesopic with glare
|
1.10 logMAR
Standard Deviation 0.03
|
1.10 logMAR
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: 3 monthsMean refraction, spherical equivalent (MRSE), in diopters
Outcome measures
| Measure |
Clareon Non-toric IOL Implantation
n=20 Eyes
The Clareon aspheric (non-toric) IOL was implanted
|
Clareon T2 IOL Implantation
n=30 Eyes
Clareon T2 (low cylinder) toric IOL implanted
|
|---|---|---|
|
Mean Refraction, Spherical Equivalent (MRSE)
|
0.47 Dioptres
Standard Deviation 0.55
|
0.22 Dioptres
Standard Deviation 0.42
|
Adverse Events
Clareon T2 IOL Implantation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clareon Non-toric IOL Implantation
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