Trial Outcomes & Findings for AcrySof IQ Toric A-Code Post-Market Clinical Study (NCT NCT03350503)
NCT ID: NCT03350503
Last Updated: 2022-12-28
Results Overview
IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)
Results posted on
2022-12-28
Participant Flow
Subjects were enrolled at 4 investigative sites located in Japan.
Of the 125 subjects enrolled, 4 were exited as screen failures prior to implantation with the test article. This reporting group includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye) (Safety Analysis Set).
Unit of analysis: eye
Participant milestones
| Measure |
AcrySof IQ Toric A-code IOL
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|
|
Overall Study
STARTED
|
121 121
|
|
Overall Study
Successful Implantation
|
120 120
|
|
Overall Study
Implanted With SN6AT3
|
61 61
|
|
Overall Study
Implanted With SN6AT4
|
27 27
|
|
Overall Study
Implanted With SN6AT5
|
33 33
|
|
Overall Study
COMPLETED
|
104 104
|
|
Overall Study
NOT COMPLETED
|
17 17
|
Reasons for withdrawal
| Measure |
AcrySof IQ Toric A-code IOL
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Continuation impossible due to move
|
4
|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
AcrySof IQ Toric A-Code Post-Market Clinical Study
Baseline characteristics by cohort
| Measure |
Acrysof IQ Toric A-code IOL
n=121 Participants
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|
|
Age, Continuous
|
75.5 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Age, Customized
Less than 60 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
60 to 69 years
|
14 Participants
n=5 Participants
|
|
Age, Customized
70 to 79 years
|
69 Participants
n=5 Participants
|
|
Age, Customized
Equal to or greater than 80 years
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
121 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
121 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)Population: All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at Visit 4.
IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted.
Outcome measures
| Measure |
Acrysof IQ Toric A-code IOL
n=114 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 (Day 1-2 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 2 (Day 7-14 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 3 (Day 30-60 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 4 (Day 120-180 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 5 (Day 330-420 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 6 (Day 630-780 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 7 (Day 990-1140 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 Through Visit 7 Cumulative
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
Less than 10 degrees rotation
|
99.1 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
Greater than or equal to 10 degrees rotation
|
0.9 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
Less than 20 degrees rotation
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
Greater than or equal to 20 degrees rotation
|
0.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
Less than 30 degrees rotation
|
100.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
Greater than or equal to 30 degrees rotation
|
0.0 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)Population: All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at both visits.
IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability.
Outcome measures
| Measure |
Acrysof IQ Toric A-code IOL
n=116 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 (Day 1-2 Postoperative)
n=118 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 2 (Day 7-14 Postoperative)
n=118 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 3 (Day 30-60 Postoperative)
n=116 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 4 (Day 120-180 Postoperative)
n=114 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 5 (Day 330-420 Postoperative)
n=109 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 6 (Day 630-780 Postoperative)
n=95 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 7 (Day 990-1140 Postoperative)
n=90 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 Through Visit 7 Cumulative
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00
Less than 10 degrees rotation
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
99.2 percentage of eyes
|
99.1 percentage of eyes
|
99.1 percentage of eyes
|
99.1 percentage of eyes
|
98.9 percentage of eyes
|
100.0 percentage of eyes
|
—
|
|
Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00
Greater than or equal to 10 degrees rotation
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.8 percentage of eyes
|
0.9 percentage of eyes
|
0.9 percentage of eyes
|
0.9 percentage of eyes
|
1.1 percentage of eyes
|
0.0 percentage of eyes
|
—
|
|
Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00
Less than 20 degrees rotation
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
—
|
|
Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00
Greater than or equal to 20 degrees rotation
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
—
|
|
Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00
Less than 30 degrees rotation
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
—
|
|
Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00
Greater than or equal to 30 degrees rotation
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)Population: All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at both visits.
IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability.
Outcome measures
| Measure |
Acrysof IQ Toric A-code IOL
n=116 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 (Day 1-2 Postoperative)
n=118 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 2 (Day 7-14 Postoperative)
n=118 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 3 (Day 30-60 Postoperative)
n=116 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 4 (Day 120-180 Postoperative)
n=114 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 5 (Day 330-420 Postoperative)
n=109 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 6 (Day 630-780 Postoperative)
n=95 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 7 (Day 990-1140 Postoperative)
n=90 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 Through Visit 7 Cumulative
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Absolute Value of IOL Rotation From Visit 00
|
2.11 degree
Standard Deviation 1.80
|
2.37 degree
Standard Deviation 1.96
|
2.22 degree
Standard Deviation 2.08
|
2.32 degree
Standard Deviation 2.14
|
2.30 degree
Standard Deviation 2.23
|
2.10 degree
Standard Deviation 2.08
|
2.31 degree
Standard Deviation 1.99
|
2.10 degree
Standard Deviation 2.06
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)Population: All Implanted Analysis Set: All eyes with successful test article implantation
Visual acuity (VA) was tested under well-lit conditions with no refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity.
Outcome measures
| Measure |
Acrysof IQ Toric A-code IOL
n=120 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 (Day 1-2 Postoperative)
n=119 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 2 (Day 7-14 Postoperative)
n=118 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 3 (Day 30-60 Postoperative)
n=118 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 4 (Day 120-180 Postoperative)
n=116 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 5 (Day 330-420 Postoperative)
n=115 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 6 (Day 630-780 Postoperative)
n=109 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 7 (Day 990-1140 Postoperative)
n=104 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 Through Visit 7 Cumulative
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Uncorrected Distance Visual Acuity (UCDVA) by Visit
|
0.551 logMAR
Standard Deviation 0.368
|
0.087 logMAR
Standard Deviation 0.170
|
0.058 logMAR
Standard Deviation 0.156
|
0.040 logMAR
Standard Deviation 0.127
|
0.054 logMAR
Standard Deviation 0.149
|
0.045 logMAR
Standard Deviation 0.163
|
0.070 logMAR
Standard Deviation 0.157
|
0.086 logMAR
Standard Deviation 0.182
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)Population: All Implanted Analysis Set: All eyes with successful test article implantation
Visual acuity (VA) was tested under well-lit conditions with refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity.
Outcome measures
| Measure |
Acrysof IQ Toric A-code IOL
n=120 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 (Day 1-2 Postoperative)
n=119 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 2 (Day 7-14 Postoperative)
n=118 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 3 (Day 30-60 Postoperative)
n=118 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 4 (Day 120-180 Postoperative)
n=116 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 5 (Day 330-420 Postoperative)
n=115 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 6 (Day 630-780 Postoperative)
n=109 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 7 (Day 990-1140 Postoperative)
n=104 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 Through Visit 7 Cumulative
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Best Corrected Distance Visual Acuity (BCDVA) by Visit
|
0.190 logMAR
Standard Deviation 0.163
|
-0.030 logMAR
Standard Deviation 0.113
|
-0.063 logMAR
Standard Deviation 0.088
|
-0.080 logMAR
Standard Deviation 0.063
|
-0.075 logMAR
Standard Deviation 0.099
|
-0.085 logMAR
Standard Deviation 0.077
|
-0.073 logMAR
Standard Deviation 0.080
|
-0.069 logMAR
Standard Deviation 0.101
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)Population: All Implanted Analysis Set: All eyes with successful test article implantation
Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Peak value is the highest value in the IOL anterior surface light scattering densitometry.
Outcome measures
| Measure |
Acrysof IQ Toric A-code IOL
n=117 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 (Day 1-2 Postoperative)
n=117 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 2 (Day 7-14 Postoperative)
n=117 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 3 (Day 30-60 Postoperative)
n=115 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 4 (Day 120-180 Postoperative)
n=114 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 5 (Day 330-420 Postoperative)
n=107 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 6 (Day 630-780 Postoperative)
n=103 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 7 (Day 990-1140 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 Through Visit 7 Cumulative
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Sub-Surface Nano Glistening (SSNG) Densitometry (Peak) by Visit
|
4.50 arbitrary units
Standard Deviation 0.70
|
4.55 arbitrary units
Standard Deviation 0.57
|
4.50 arbitrary units
Standard Deviation 0.55
|
4.48 arbitrary units
Standard Deviation 0.64
|
4.64 arbitrary units
Standard Deviation 0.78
|
4.82 arbitrary units
Standard Deviation 0.63
|
5.11 arbitrary units
Standard Deviation 0.76
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)Population: All Implanted Analysis Set: All eyes with successful test article implantation
Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Area analysis value is an average value of the IOL anterior surface light scattering densitometry in a certain area.
Outcome measures
| Measure |
Acrysof IQ Toric A-code IOL
n=117 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 (Day 1-2 Postoperative)
n=117 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 2 (Day 7-14 Postoperative)
n=117 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 3 (Day 30-60 Postoperative)
n=115 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 4 (Day 120-180 Postoperative)
n=114 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 5 (Day 330-420 Postoperative)
n=107 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 6 (Day 630-780 Postoperative)
n=103 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 7 (Day 990-1140 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 Through Visit 7 Cumulative
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean SSNG Densitometry (Area Analysis) by Visit
|
4.07 arbitrary units
Standard Deviation 0.50
|
4.12 arbitrary units
Standard Deviation 0.47
|
4.08 arbitrary units
Standard Deviation 0.46
|
4.05 arbitrary units
Standard Deviation 0.42
|
4.19 arbitrary units
Standard Deviation 0.38
|
4.30 arbitrary units
Standard Deviation 0.41
|
4.45 arbitrary units
Standard Deviation 0.48
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)Population: Safety Analysis Set
A device deficiency was defined as an inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety, or performance.
Outcome measures
| Measure |
Acrysof IQ Toric A-code IOL
n=121 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 (Day 1-2 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 2 (Day 7-14 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 3 (Day 30-60 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 4 (Day 120-180 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 5 (Day 330-420 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 6 (Day 630-780 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 7 (Day 990-1140 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 Through Visit 7 Cumulative
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Device Deficiencies
Broken IOL haptic
|
0 device deficiency
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Device Deficiencies
IOL luxation
|
0 device deficiency
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Device Deficiencies
IOL dislocation
|
0 device deficiency
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Device Deficiencies
Other: IOL rotation
|
2 device deficiency
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Device Deficiencies
Broken IOL optic
|
0 device deficiency
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)Population: Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment.
A slit lamp examination was conducted to determine the presence/absence of glistening particles on the implanted IOL. Glistening was reported by on a 4-point scale, where Grade 0 = no glistening; Grade 1 = mild glistening (50/mm3); Grade 2 = moderate glistening (100/mm3); and Grade 3 = severe glistening (200/mm3).
Outcome measures
| Measure |
Acrysof IQ Toric A-code IOL
n=120 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 (Day 1-2 Postoperative)
n=119 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 2 (Day 7-14 Postoperative)
n=119 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 3 (Day 30-60 Postoperative)
n=117 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 4 (Day 120-180 Postoperative)
n=116 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 5 (Day 330-420 Postoperative)
n=101 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 6 (Day 630-780 Postoperative)
n=104 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 7 (Day 990-1140 Postoperative)
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 Through Visit 7 Cumulative
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Eyes With Glistening by Visit
Grade 0
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
100.0 percentage of eyes
|
88.0 percentage of eyes
|
68.1 percentage of eyes
|
59.4 percentage of eyes
|
49.0 percentage of eyes
|
—
|
—
|
|
Percentage of Eyes With Glistening by Visit
Grade 1
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
9.4 percentage of eyes
|
20.7 percentage of eyes
|
21.8 percentage of eyes
|
27.9 percentage of eyes
|
—
|
—
|
|
Percentage of Eyes With Glistening by Visit
Grade 2
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
2.6 percentage of eyes
|
7.8 percentage of eyes
|
13.9 percentage of eyes
|
15.4 percentage of eyes
|
—
|
—
|
|
Percentage of Eyes With Glistening by Visit
Grade 3
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
3.4 percentage of eyes
|
5.0 percentage of eyes
|
7.7 percentage of eyes
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7Population: Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment.
A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). The presence or absence of PCO was recorded. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Acrysof IQ Toric A-code IOL
n=120 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 (Day 1-2 Postoperative)
n=119 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 2 (Day 7-14 Postoperative)
n=119 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 3 (Day 30-60 Postoperative)
n=117 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 4 (Day 120-180 Postoperative)
n=116 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 5 (Day 330-420 Postoperative)
n=105 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 6 (Day 630-780 Postoperative)
n=104 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 7 (Day 990-1140 Postoperative)
n=21 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 Through Visit 7 Cumulative
n=120 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Eyes With Posterior Capsule Opacification (PCO) by Visit
Clinically nonsignificant
|
0 eye
|
1 eye
|
7 eye
|
12 eye
|
16 eye
|
26 eye
|
34 eye
|
0 eye
|
39 eye
|
|
Number of Eyes With Posterior Capsule Opacification (PCO) by Visit
None
|
120 eye
|
118 eye
|
112 eye
|
105 eye
|
100 eye
|
79 eye
|
66 eye
|
16 eye
|
74 eye
|
|
Number of Eyes With Posterior Capsule Opacification (PCO) by Visit
Clinically significant
|
0 eye
|
0 eye
|
0 eye
|
0 eye
|
0 eye
|
0 eye
|
2 eye
|
2 eye
|
2 eye
|
|
Number of Eyes With Posterior Capsule Opacification (PCO) by Visit
Clinically significant requiring Nd:YAG laser treatment
|
0 eye
|
0 eye
|
0 eye
|
0 eye
|
0 eye
|
0 eye
|
2 eye
|
3 eye
|
5 eye
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7Population: Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment.
A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). A neodymium-doped yttrium aluminum garnet (Nd:YAG) laser was used to treat posterior capsule opacification, with treatment determined by the investigator. The presence or absence of Nd:YAG laser treament was recorded.
Outcome measures
| Measure |
Acrysof IQ Toric A-code IOL
n=120 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 (Day 1-2 Postoperative)
n=119 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 2 (Day 7-14 Postoperative)
n=119 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 3 (Day 30-60 Postoperative)
n=117 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 4 (Day 120-180 Postoperative)
n=116 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 5 (Day 330-420 Postoperative)
n=110 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 6 (Day 630-780 Postoperative)
n=104 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 7 (Day 990-1140 Postoperative)
n=32 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
Visit 1 Through Visit 7 Cumulative
n=120 eye
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Eyes Receiving Nd:YAG Laser Treatment for Posterior Capsule Opacification (PCO) by Visit
No
|
120 eye
|
119 eye
|
119 eye
|
117 eye
|
116 eye
|
110 eye
|
103 eye
|
29 eye
|
116 eye
|
|
Number of Eyes Receiving Nd:YAG Laser Treatment for Posterior Capsule Opacification (PCO) by Visit
Yes
|
0 eye
|
0 eye
|
0 eye
|
0 eye
|
0 eye
|
0 eye
|
1 eye
|
3 eye
|
4 eye
|
Adverse Events
Acrysof IQ Toric A-code IOL
Serious events: 15 serious events
Other events: 7 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Acrysof IQ Toric A-code IOL
n=121 participants at risk
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally
|
|---|---|
|
Nervous system disorders
Cerebral infarction
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Infections and infestations
Pneumonia
|
1.7%
2/121 • Number of events 2 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Gastrointestinal disorders
Haemmorhoids
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.7%
2/121 • Number of events 2 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Cardiac disorders
Cardiac failure
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
General disorders
Pyrexia
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Renal and urinary disorders
Bladder prolapse
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
|
Eye disorders
Dermatochalasis
|
0.83%
1/121 • Number of events 1 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
Other adverse events
| Measure |
Acrysof IQ Toric A-code IOL
n=121 participants at risk
AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally
|
|---|---|
|
Eye disorders
Posterior capsule opacification
|
5.8%
7/121 • Number of events 7 • Adverse events are reported for the duration of individual participation (up to 990-1140 days).
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).
|
Additional Information
Expert Clinical Project Lead, CDMA Surgical
Alcon Research
Phone: 1-888-451-3937
Email: [email protected]
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