Trial Outcomes & Findings for AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0] in Japan (NCT NCT01605877)
NCT ID: NCT01605877
Last Updated: 2015-07-07
Results Overview
Visual acuity (VA) was tested monocularly (each eye separately) at all visits and binocularly (both eyes together) at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Results posted on
2015-07-07
Participant Flow
Subjects were recruited from 2 study sites located in Japan.
Of the 70 subjects enrolled, 6 were discontinued prior to first implantation due to withdrawn consent (1) and meeting exclusion criteria (5). This reporting group includes all implanted subjects (64).
Participant milestones
| Measure |
SN6AD2
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\], bilateral implantation
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
SN6AD2
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\], bilateral implantation
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0] in Japan
Baseline characteristics by cohort
| Measure |
SN6AD2
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\], bilateral implantation
|
|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Age, Customized
<60 years
|
10 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
29 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
24 participants
n=5 Participants
|
|
Age, Customized
≥ 80 years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
Visual acuity (VA) was tested monocularly (each eye separately) at all visits and binocularly (both eyes together) at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Uncorrected Decimal VA (5 m)
First Eye worse than 0.5 decimal
|
48 participants
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Uncorrected Decimal VA (5 m)
First Eye 0.5 to less than 0.7 decimal
|
9 participants
|
9 participants
|
6 participants
|
9 participants
|
7 participants
|
6 participants
|
|
Uncorrected Decimal VA (5 m)
First Eye 0.7 to less than1.0 decimal
|
6 participants
|
22 participants
|
17 participants
|
19 participants
|
20 participants
|
13 participants
|
|
Uncorrected Decimal VA (5 m)
First Eye 1.0 decimal or better
|
1 participants
|
30 participants
|
40 participants
|
36 participants
|
37 participants
|
44 participants
|
|
Uncorrected Decimal VA (5 m)
Second Eye worse than 0.5 decimal
|
49 participants
|
7 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Uncorrected Decimal VA (5 m)
Second Eye 0.5 to less than 0.7 decimal
|
5 participants
|
7 participants
|
8 participants
|
7 participants
|
6 participants
|
3 participants
|
|
Uncorrected Decimal VA (5 m)
Second Eye 0.7 to less than 1.0 decimal
|
8 participants
|
21 participants
|
17 participants
|
21 participants
|
17 participants
|
22 participants
|
|
Uncorrected Decimal VA (5 m)
Binocular worse than 0.5 decimal
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
0 participants
|
0 participants
|
0 participants
|
|
Uncorrected Decimal VA (5 m)
Second Eye 1.0 decimal or better
|
2 participants
|
29 participants
|
38 participants
|
36 participants
|
41 participants
|
38 participants
|
|
Uncorrected Decimal VA (5 m)
Binocular 0.5 to less than 0.7 decimal
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
2 participants
|
0 participants
|
1 participants
|
|
Uncorrected Decimal VA (5 m)
Binocular 0.7 to less than 1.0 decimal
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
14 participants
|
14 participants
|
7 participants
|
|
Uncorrected Decimal VA (5 m)
Binocular 1.0 decimal or better
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
48 participants
|
50 participants
|
55 participants
|
PRIMARY outcome
Timeframe: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 50 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Uncorrected Decimal VA (50 cm)
First Eye 0.4 decimal or better
|
15 participants
|
52 participants
|
58 participants
|
60 participants
|
59 participants
|
61 participants
|
|
Uncorrected Decimal VA (50 cm)
Second Eye worse than 0.4 decimal
|
44 participants
|
11 participants
|
4 participants
|
3 participants
|
5 participants
|
3 participants
|
|
Uncorrected Decimal VA (50 cm)
Binocular worse than 0.4 decimal
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
2 participants
|
2 participants
|
0 participants
|
|
Uncorrected Decimal VA (50 cm)
Binocular 0.4 decimal or better
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
62 participants
|
62 participants
|
63 participants
|
|
Uncorrected Decimal VA (50 cm)
First Eye worse than 0.4 decimal
|
49 participants
|
12 participants
|
6 participants
|
4 participants
|
5 participants
|
2 participants
|
|
Uncorrected Decimal VA (50 cm)
Second Eye 0.4 decimal or better
|
20 participants
|
53 participants
|
60 participants
|
61 participants
|
59 participants
|
60 participants
|
PRIMARY outcome
Timeframe: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 5 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Best Corrected Decimal VA (5 m)
First Eye 0.5 to less than 0.7 decimal
|
18 participants
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Best Corrected Decimal VA (5 m)
First Eye 0.7 to less than 1.0 decimal
|
10 participants
|
14 participants
|
3 participants
|
3 participants
|
2 participants
|
4 participants
|
|
Best Corrected Decimal VA (5 m)
First Eye 1.0 decimal or better
|
14 participants
|
47 participants
|
61 participants
|
61 participants
|
61 participants
|
59 participants
|
|
Best Corrected Decimal VA (5 m)
Second Eye worse than 0.5 decimal
|
15 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Best Corrected Decimal VA (5 m)
Second Eye 0.5 to less than 0.7 decimal
|
11 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Best Corrected Decimal VA (5 m)
Second Eye 0.7 to less than 1.0 decimal
|
17 participants
|
17 participants
|
3 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Best Corrected Decimal VA (5 m)
Second Eye 1.0 decimal or better
|
21 participants
|
47 participants
|
61 participants
|
62 participants
|
63 participants
|
61 participants
|
|
Best Corrected Decimal VA (5 m)
Binocular worse than 0.5 decimal
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
0 participants
|
0 participants
|
0 participants
|
|
Best Corrected Decimal VA (5 m)
Binocular 0.5 to less than 0.7 decimal
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
0 participants
|
0 participants
|
0 participants
|
|
Best Corrected Decimal VA (5 m)
Binocular 0.7 to less than 1.0 decimal
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
0 participants
|
1 participants
|
1 participants
|
|
Best Corrected Decimal VA (5 m)
Binocular 1.0 decimal or better
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
64 participants
|
63 participants
|
62 participants
|
|
Best Corrected Decimal VA (5 m)
First Eye worse than 0.5 decimal
|
22 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 50 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Best Corrected Decimal VA (50 cm)
First Eye worse than 0.5 decimal
|
22 participants
|
7 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Best Corrected Decimal VA (50 cm)
First Eye 0.5 to less than 0.7 decimal
|
19 participants
|
22 participants
|
9 participants
|
7 participants
|
8 participants
|
5 participants
|
|
Best Corrected Decimal VA (50 cm)
First Eye 0.7 to less than 1.0 decimal
|
12 participants
|
30 participants
|
38 participants
|
39 participants
|
35 participants
|
32 participants
|
|
Best Corrected Decimal VA (50 cm)
First Eye 1.0 decimal or better
|
11 participants
|
5 participants
|
16 participants
|
18 participants
|
21 participants
|
25 participants
|
|
Best Corrected Decimal VA (50 cm)
Second Eye worse than 0.5 decimal
|
11 participants
|
4 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Best Corrected Decimal VA (50 cm)
Second Eye 0.5 to less than 0.7 decimal
|
19 participants
|
22 participants
|
6 participants
|
3 participants
|
4 participants
|
4 participants
|
|
Best Corrected Decimal VA (50 cm)
Second Eye 0.7 to less than 1.0 decimal
|
17 participants
|
28 participants
|
43 participants
|
42 participants
|
37 participants
|
28 participants
|
|
Best Corrected Decimal VA (50 cm)
Second Eye 1.0 decimal or better
|
17 participants
|
10 participants
|
15 participants
|
19 participants
|
22 participants
|
30 participants
|
|
Best Corrected Decimal VA (50 cm)
Binocular 0.5 to less than 0.7 decimal
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
0 participants
|
2 participants
|
2 participants
|
|
Best Corrected Decimal VA (50 cm)
Binocular 0.7 to less than 1.0 decimal
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
29 participants
|
26 participants
|
17 participants
|
|
Best Corrected Decimal VA (50 cm)
Binocular 1.0 decimal or better
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
35 participants
|
36 participants
|
44 participants
|
|
Best Corrected Decimal VA (50 cm)
Binocular worse than 0.5 decimal
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
VA was tested monocularly at the preoperative, Day 30-60, Day 120-180, and Day 330-420 visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart. Distance-corrected VA at 50 cm is the VA at 50 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Distance-Corrected Decimal VA (50 cm)
First Eye worse than 0.4 decimal
|
48 participants
|
4 participants
|
4 participants
|
2 participants
|
—
|
—
|
|
Distance-Corrected Decimal VA (50 cm)
First Eye 0.4 decimal or better
|
16 participants
|
60 participants
|
60 participants
|
61 participants
|
—
|
—
|
|
Distance-Corrected Decimal VA (50 cm)
Second Eye worse than 0.4 decimal
|
43 participants
|
4 participants
|
4 participants
|
2 participants
|
—
|
—
|
|
Distance-Corrected Decimal VA (50 cm)
Second Eye 0.4 decimal or better
|
21 participants
|
60 participants
|
60 participants
|
61 participants
|
—
|
—
|
|
Distance-Corrected Decimal VA (50 cm)
Binocular worse than 0.4 decimal
|
NA participants
Not Assessed
|
0 participants
|
2 participants
|
1 participants
|
—
|
—
|
|
Distance-Corrected Decimal VA (50 cm)
Binocular 0.4 decimal or better
|
NA participants
Not Assessed
|
64 participants
|
62 participants
|
62 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
VA was tested binocularly unaided at a distance of 1 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Uncorrected Decimal VA (1 m)
Worse than 0.5 decimal
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
|
Uncorrected Decimal VA (1 m)
0.5 to less than 0.7 decimal
|
8 participants
|
3 participants
|
—
|
—
|
—
|
—
|
|
Uncorrected Decimal VA (1 m)
0.7 to less than 1.0 decimal
|
20 participants
|
22 participants
|
—
|
—
|
—
|
—
|
|
Uncorrected Decimal VA (1 m)
1.0 decimal or better
|
36 participants
|
38 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
VA was tested binocularly using a chart. Distance-corrected VA at 1 m is the VA at 1 m measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Distance Corrected Decimal VA (1 m)
Worse than 0.5 decimal
|
3 participants
|
0 participants
|
—
|
—
|
—
|
—
|
|
Distance Corrected Decimal VA (1 m)
0.5 to less than 0.7 decimal
|
4 participants
|
3 participants
|
—
|
—
|
—
|
—
|
|
Distance Corrected Decimal VA (1 m)
0.7 to less than 1.0 decimal
|
24 participants
|
26 participants
|
—
|
—
|
—
|
—
|
|
Distance Corrected Decimal VA (1 m)
1.0 decimal or better
|
33 participants
|
34 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
VA was tested binocularly unaided at a distance of 40 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Uncorrected Decimal VA (40 cm)
Worse than 0.4 decimal
|
3 participants
|
2 participants
|
—
|
—
|
—
|
—
|
|
Uncorrected Decimal VA (40 cm)
0.4 decimal or better
|
61 participants
|
61 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
VA was tested binocularly using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Distance Corrected Decimal VA (40 cm)
Worse than 0.4 decimal
|
2 participants
|
2 participants
|
—
|
—
|
—
|
—
|
|
Distance Corrected Decimal VA (40 cm)
0.4 decimal or better
|
62 participants
|
61 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart at the distance of best near vision (cm) as decided by the participant. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Uncorrected Decimal VA at Best Distance
First Eye worse than 0.4 decimal
|
52 participants
|
13 participants
|
6 participants
|
4 participants
|
5 participants
|
3 participants
|
|
Uncorrected Decimal VA at Best Distance
First Eye 0.4 decimal or better
|
12 participants
|
51 participants
|
58 participants
|
60 participants
|
59 participants
|
60 participants
|
|
Uncorrected Decimal VA at Best Distance
Second Eye worse than 0.4 decimal
|
48 participants
|
14 participants
|
6 participants
|
4 participants
|
3 participants
|
5 participants
|
|
Uncorrected Decimal VA at Best Distance
Binocular worse than 0.4 decimal
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
2 participants
|
2 participants
|
1 participants
|
|
Uncorrected Decimal VA at Best Distance
Binocular 0.4 decimal or better
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
NA participants
Not Assessed
|
62 participants
|
62 participants
|
62 participants
|
|
Uncorrected Decimal VA at Best Distance
Second Eye 0.4 decimal or better
|
16 participants
|
50 participants
|
58 participants
|
60 participants
|
61 participants
|
58 participants
|
SECONDARY outcome
Timeframe: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group, respectively.
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided using a chart. The participant indicated the distance (cm) at which best near vision was attained.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Mean Best Distance (cm) for Uncorrected Decimal Near VA
First Eye (n=45,64,64,64,64,63)
|
40.5 centimeters
Standard Deviation 11.6
|
46.9 centimeters
Standard Deviation 5.2
|
47.3 centimeters
Standard Deviation 4.4
|
47.2 centimeters
Standard Deviation 3.8
|
47.3 centimeters
Standard Deviation 3.6
|
48.5 centimeters
Standard Deviation 3.6
|
|
Mean Best Distance (cm) for Uncorrected Decimal Near VA
Second Eye (n=47,64,64,64,64,63)
|
39.8 centimeters
Standard Deviation 12.0
|
47.1 centimeters
Standard Deviation 3.8
|
46.9 centimeters
Standard Deviation 4.0
|
46.9 centimeters
Standard Deviation 3.7
|
47.5 centimeters
Standard Deviation 3.9
|
48.5 centimeters
Standard Deviation 3.7
|
|
Mean Best Distance (cm) for Uncorrected Decimal Near VA
Binocular (n=NA,NA,NA,64,64,63)
|
NA centimeters
Standard Deviation NA
Not Assessed
|
NA centimeters
Standard Deviation NA
Not Assessed
|
NA centimeters
Standard Deviation NA
Not Assessed
|
47.0 centimeters
Standard Deviation 3.9
|
47.8 centimeters
Standard Deviation 3.6
|
48.9 centimeters
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
VA was tested monocularly at Day 1-2, Day 7-14, Day 30-60, Day 120-180, and Day 330-420 and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction using a chart. The participant indicated the distance (cm) at which best near vision was attained.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
n=63 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Mean Best Distance (cm) for Distance Corrected Decimal Near VA
First Eye
|
48.2 centimeters
Standard Deviation 4.5
|
49.5 centimeters
Standard Deviation 4.4
|
48.6 centimeters
Standard Deviation 3.9
|
49.1 centimeters
Standard Deviation 3.3
|
49.4 centimeters
Standard Deviation 3.2
|
—
|
|
Mean Best Distance (cm) for Distance Corrected Decimal Near VA
Second Eye
|
48.2 centimeters
Standard Deviation 4.3
|
48.3 centimeters
Standard Deviation 3.5
|
48.5 centimeters
Standard Deviation 3.6
|
49.0 centimeters
Standard Deviation 3.3
|
49.2 centimeters
Standard Deviation 3.5
|
—
|
|
Mean Best Distance (cm) for Distance Corrected Decimal Near VA
Binocular
|
NA centimeters
Standard Deviation NA
Not Assessed
|
NA centimeters
Standard Deviation NA
Not Assessed
|
48.8 centimeters
Standard Deviation 3.9
|
48.8 centimeters
Standard Deviation 3.1
|
49.5 centimeters
Standard Deviation 3.1
|
—
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: This analysis population includes all implanted subjects.
Far contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 3 m using the Vector Vision CSV 1000 illuminated box (one site) and the Vision Contrast Test System (other site). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). For CSV 1000, contrast sensitivity was not measured at spatial frequency 1.5 cpd because there was no option for this frequency. Raw scores were transformed to logMar (logarithm of the minimum angle of resolution) units. A higher numeric value represents better contrast sensitivity.
Outcome measures
| Measure |
Preoperative
n=32 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
n=32 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Best Corrected Far (3 m) Contrast Sensitivity
6 cpd
|
2.026 logMAR
Standard Deviation 0.138
|
2.080 logMAR
Standard Deviation 0.187
|
—
|
—
|
—
|
—
|
|
Best Corrected Far (3 m) Contrast Sensitivity
12 cpd
|
1.673 logMAR
Standard Deviation 0.186
|
1.800 logMAR
Standard Deviation 0.273
|
—
|
—
|
—
|
—
|
|
Best Corrected Far (3 m) Contrast Sensitivity
18 cpd
|
1.176 logMAR
Standard Deviation 0.223
|
1.356 logMAR
Standard Deviation 0.244
|
—
|
—
|
—
|
—
|
|
Best Corrected Far (3 m) Contrast Sensitivity
1.5 cpd
|
NA logMAR
Standard Deviation NA
Not an option for CSV-1000; therefore, not assessed.
|
1.760 logMAR
Standard Deviation 0.227
|
—
|
—
|
—
|
—
|
|
Best Corrected Far (3 m) Contrast Sensitivity
3 cpd
|
1.889 logMAR
Standard Deviation 0.130
|
2.047 logMAR
Standard Deviation 0.200
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: This analysis population includes all implanted subjects.
Near contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 46 cm using the Functional Acuity Contrast Test (FACT). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). Raw scores were transformed to logMar units. A higher numeric value represents better contrast sensitivity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Best Corrected Near (46 cm) Contrast Sensitivity
1.5 cpd
|
1.825 logMAR
Standard Deviation 0.121
|
—
|
—
|
—
|
—
|
—
|
|
Best Corrected Near (46 cm) Contrast Sensitivity
3 cpd
|
1.933 logMAR
Standard Deviation 0.137
|
—
|
—
|
—
|
—
|
—
|
|
Best Corrected Near (46 cm) Contrast Sensitivity
6 cpd
|
1.739 logMAR
Standard Deviation 0.192
|
—
|
—
|
—
|
—
|
—
|
|
Best Corrected Near (46 cm) Contrast Sensitivity
12 cpd
|
1.311 logMAR
Standard Deviation 0.220
|
—
|
—
|
—
|
—
|
—
|
|
Best Corrected Near (46 cm) Contrast Sensitivity
18 cpd
|
0.856 logMAR
Standard Deviation 0.220
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: This analysis population includes all implanted subjects.
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction at a distance of 5 m using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Mean Defocus Decimal VA (5 m)
+2.00
|
0.44 decimal
Interval 0.24 to 0.82
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
+1.50
|
0.65 decimal
Interval 0.38 to 1.1
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
+1.00
|
0.85 decimal
Interval 0.57 to 1.26
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
+0.50
|
1.11 decimal
Interval 0.82 to 1.5
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
0.00
|
1.43 decimal
Interval 1.16 to 1.76
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
-0.50
|
1.16 decimal
Interval 0.9 to 1.49
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
-1.00
|
0.93 decimal
Interval 0.68 to 1.28
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
-1.50
|
0.84 decimal
Interval 0.62 to 1.15
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
-2.00
|
0.94 decimal
Interval 0.67 to 1.31
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
-2.50
|
0.73 decimal
Interval 0.51 to 1.05
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
-3.00
|
0.51 decimal
Interval 0.32 to 0.8
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
-3.50
|
0.36 decimal
Interval 0.22 to 0.58
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
-4.00
|
0.25 decimal
Interval 0.15 to 0.41
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
-4.50
|
0.19 decimal
Interval 0.11 to 0.3
|
—
|
—
|
—
|
—
|
—
|
|
Mean Defocus Decimal VA (5 m)
-5.00
|
0.14 decimal
Interval 0.08 to 0.24
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: This analysis population includes all implanted subjects.
Stereopsis (the ability to perceive depth and 3-dimensional structure) was assessed binocularly under well-lit conditions at best distance using the Stereo Optical Company, Inc., Original Stereo Fly Test and polarized viewers. The participant was shown a series of symbols, with a positive response defined as correct identification of the 3-dimensional symbol. Responses were recorded for 3 symbols: Fly (easiest to perceive), animal, and circle (hardest to perceive).
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Response, Stereoscopic Vision Test
House Fly
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Stereoscopic Vision Test
Animal
|
93.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Stereoscopic Vision Test
Circle
|
85.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: This analysis population includes all implanted subjects.
The participant completed a questionnaire, indicating (yes/no) if he/she experienced visual difficulty in every-day activities while not wearing spectacles. A positive response was defined as, "Yes=visual difficulty."
Outcome measures
| Measure |
Preoperative
n=64 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 1-2
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 7-14
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 30-60
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 120-180
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
Day 330-420
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Reading small print, labels, telephone book
|
89.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Reading a newspaper or a book
|
81.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Reading dial plate of a wrist watch
|
10.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Reading headline in a newspaper or book
|
7.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Writing on papers or documents
|
60.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Playing games such as chess, cards, mah-jongg
|
1.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Drawing, sewing, knitting, or handiwork
|
51.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Cooking
|
15.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Watching TV
|
3.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Seeing steps or stairs
|
3.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Recognizing people when they are close
|
1.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Play table tennis, gate ball, tennis, golf, bowl
|
4.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Reading a timetable in subway or train station
|
6.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Reading plate of a bus or train coming
|
1.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Reading traffic sign or shop sign
|
1.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Seeing a PC screen
|
42.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Seeing face in the mirror during makeup or shaving
|
18.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Seeing distant blackboard or slide
|
39.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Positive Response, Quality of Life Questions
Reading dial plate of clock or numbers on calendar
|
3.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SN6AD2
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SN6AD2
n=64 participants at risk
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\], bilateral implantation
|
|---|---|
|
Eye disorders
Uveitis
|
1.6%
1/64 • Adverse events (AEs) were collected from time of lens implantation for the duration of the study (May 9, 2012 to December 10, 2013). This reporting group includes all implanted subjects.
An AE was defined as any untoward medical occurrence in a subject, user or other person regardless of whether or not the event had a causal relationship with the medical device or test procedures. Secondary surgical intervention (SSI) was also reported as an AE. AEs were collected as solicited comments and as observations by the study investigator.
|
|
Infections and infestations
Urinary Tract Infection
|
1.6%
1/64 • Adverse events (AEs) were collected from time of lens implantation for the duration of the study (May 9, 2012 to December 10, 2013). This reporting group includes all implanted subjects.
An AE was defined as any untoward medical occurrence in a subject, user or other person regardless of whether or not the event had a causal relationship with the medical device or test procedures. Secondary surgical intervention (SSI) was also reported as an AE. AEs were collected as solicited comments and as observations by the study investigator.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.6%
1/64 • Adverse events (AEs) were collected from time of lens implantation for the duration of the study (May 9, 2012 to December 10, 2013). This reporting group includes all implanted subjects.
An AE was defined as any untoward medical occurrence in a subject, user or other person regardless of whether or not the event had a causal relationship with the medical device or test procedures. Secondary surgical intervention (SSI) was also reported as an AE. AEs were collected as solicited comments and as observations by the study investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.6%
1/64 • Adverse events (AEs) were collected from time of lens implantation for the duration of the study (May 9, 2012 to December 10, 2013). This reporting group includes all implanted subjects.
An AE was defined as any untoward medical occurrence in a subject, user or other person regardless of whether or not the event had a causal relationship with the medical device or test procedures. Secondary surgical intervention (SSI) was also reported as an AE. AEs were collected as solicited comments and as observations by the study investigator.
|
|
Nervous system disorders
Intra-cerebral haemorrhage
|
1.6%
1/64 • Adverse events (AEs) were collected from time of lens implantation for the duration of the study (May 9, 2012 to December 10, 2013). This reporting group includes all implanted subjects.
An AE was defined as any untoward medical occurrence in a subject, user or other person regardless of whether or not the event had a causal relationship with the medical device or test procedures. Secondary surgical intervention (SSI) was also reported as an AE. AEs were collected as solicited comments and as observations by the study investigator.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.6%
1/64 • Adverse events (AEs) were collected from time of lens implantation for the duration of the study (May 9, 2012 to December 10, 2013). This reporting group includes all implanted subjects.
An AE was defined as any untoward medical occurrence in a subject, user or other person regardless of whether or not the event had a causal relationship with the medical device or test procedures. Secondary surgical intervention (SSI) was also reported as an AE. AEs were collected as solicited comments and as observations by the study investigator.
|
Other adverse events
Adverse event data not reported
Additional Information
Hiroshi Kodama, Group Manager
Alcon Japan, Ltd.
Phone: 81-3-6899-5000
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